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1.  Total Knee Replacement 
Executive Summary
Objective
The aim of this review was to assess the effectiveness, in terms of pain reduction and functional improvement, and costing of total knee replacement (TKR) for people with osteoarthritis for whom less invasive treatments (such as physiotherapy, analgesics, anti-inflammatory drugs, intra-articular steroids, hyaluronic acids, and arthroscopic surgery) have failed.
Clinical Need
Osteoarthritis affects an estimated 10% to 12% of Canadian adults. The therapeutic goals of osteoarthritis treatment are to improve joint mobility and reduce pain. Stepwise treatment options include exercise, weight loss, physiotherapy, analgesics, anti-inflammatory drugs, intra-articular steroids and hyaluronic acids, arthroscopic surgery, and, in severe cases, total joint replacement with follow-up rehabilitation. These treatments are delivered by a range of health care professionals, including physiotherapists, occupational therapists, family physicians, internists, rheumatologists, and orthopedic surgeons. TKR is an end-of-line treatment for patients with severe pain and functional limitations. More women than men undergo knee replacement, and most patients are between 55 and 84 years old.
The Technology
TKR is a surgical procedure in which an artificial joint or prosthesis replaces a damaged knee joint. The primary indication for TKR is pain, followed by functional limitation. Usually, a person’s daily activities must be substantially affected by pain and functional limitations for him or her to be considered a candidate for TKR.
There are 3 different types of knee replacement prostheses. Non-constrained prostheses use the patient’s ligaments and muscles to provide the stability for the prosthesis. Semi-constrained prostheses provide some stability for the knee and do not rely entirely on the patient’s ligaments and muscles to provide the stability. Constrained prostheses are for patients whose ligaments and muscles are not able to provide stability for the knee prosthesis.
The most common risks and complications associated with TKR are deep venous thrombosis, infection, stiffness, loosening, and osteolysis. To prevent deep venous thrombosis, patients are treated with heparin prophylactically and/or given support stockings to wear. Patients are also given antibiotics for 24 hours after surgery to minimize the risk of infection. Stiffness is another associated complication. In most patients, it can be avoided by keeping the knee moving in the days and weeks following surgery.
The National Institutes of Health in the United States concluded that the indications for TKR should include the following: radiological evidence of joint damage, moderate to severe persistent pain that is not adequately relieved by nonsurgical management, and clinically significant functional limitation resulting in diminished quality of life.
Review Strategy
In March 2005, the following databases were searched: Cochrane Library International Agency for Health Technology Assessment (first quarter 2005), Cochrane Database of Systematic Reviews (first quarter 2005), Cochrane Central Register of Controlled Trials (first quarter 2005), MEDLINE (1966 to March 2005), MEDLINE In-Process and Other Non-indexed Citations (1966 to March 14, 2005), and EMBASE (1980 to 2005 week 9). The Medical Advisory Secretariat also searched Medscape on the Internet for recent reports on trials that were unpublished but that were presented at international conferences. In addition, the Web site Current Controlled Trials (www.controlled-trials.com) was searched for ongoing trials investigating TKR or unicompartmental knee replacement.
No studies were identified that compared TKR to an alternative treatment. Several studies have been reported that compare preoperative measurement scores on targeted measures of functioning and pain to postoperative measurement scores in patients undergoing various TKR procedures.
In order for the Medical Advisory Secretariat to measure the effectiveness of TKR and to compare the effectiveness of TKR across studies, effect sizes were calculated in studies that reported the standard deviations of the preoperative and postoperative measurement scores. Percent change was also calculated. For this review, a 20% improvement in outcome score was defined as the minimal clinically important difference.
Summary of Findings
Overall, patients who undergo TKR surgery for osteoarthritis have substantial improvements in terms of reduction of pain and improvement of function. A comparison of the mean effect score and the percent change in 19 studies that reported preoperative and postoperative outcome scores for patients who had TKR showed that the procedure is effective. The 19 studies included patients of various ages and used a variety of prostheses and techniques to implant the device. TKR was effective in all of the studies. The revision rates ranged from 0% to 13% in the studies that reported at least 5 years of follow-up.
As for the factors that predict TKR outcomes, a variety of factors have been evaluated, including obesity, age, gender, prosthesis design, and surgical techniques; however, none of these have been shown to predict outcomes (pain or function) consistently across studies. However, the regression analyses identified accounted for only 12% to 27% of the variance, indicating that over 70% of the variance in the outcomes of TKR is unexplained.
In terms of the timing of TKR surgery, 2 studies found that the severity of osteoarthritis does not predict outcome, but 1 study was found that higher functioning patients had significantly less pain and better function up to 2 years after surgery compared with lower functioning patients. It is important to note that the patients in the low and high function groups were evenly matched on comorbid conditions.
Unicompartmental knee replacement surgery seems to be as effective as TKR surgery for people who meet the indications for it. This is a subset of people who have osteoarthritis of the knee, because for unicompartmental knee replacement to be indicated, only 1 (usually the medial) compartment of the knee can be affected. Patients who undergo this kind of surgery seem to have shorter hospital stays and faster recovery times than do patients who have TKR surgery.
Conclusion
There is substantial evidence to indicate that TKR effectively reduces pain and improves function.
PMCID: PMC3382388  PMID: 23074478
2.  Consenting Operative Orthopaedic Trauma Patients: Challenges and Solutions 
ISRN Surgery  2014;2014:354239.
Guidelines exist to obtain informed consent before any operative procedure. We completed an audit cycle starting with retrospective review of 50 orthopaedic trauma procedures (Phase 1 over three months to determine the quality of consenting documentation). The results were conveyed and adequate training of the staff was arranged according to guidelines from BOA, DoH, and GMC. Compliance in filling consent forms was then prospectively assessed on 50 consecutive trauma surgeries over further three months (Phase 2). Use of abbreviations was significantly reduced (P = 0.03) in Phase 2 (none) compared to 10 (20%) in Phase 1 with odds ratio of 0.04. Initially, allocation of patient's copy was dispensed in three (6% in Phase 1) cases compared to 100% in Phase 2, when appropriate. Senior doctors (registrars or consultant) filled most consent forms. However, 7 (14%) consent forms in Phase 1 and eleven (22%) in Phase 2 were signed by Core Surgical Trainees year 2, which reflects the difference in seniority amongst junior doctors. The requirement for blood transfusion was addressed in 40% of cases where relevant and 100% cases in Phase 2. Consenting patients for trauma surgery improved in Phase 2. Regular audit is essential to maintain expected national standards.
doi:10.1155/2014/354239
PMCID: PMC3933397  PMID: 24653843
3.  Rationing of total knee replacement: a cost-effectiveness analysis on a large trial data set 
BMJ Open  2012;2(1):e000332.
Objectives
Many UK primary care trusts have recently introduced eligibility criteria restricting total knee replacement (TKR) to patients with low pre-operative Oxford Knee Scores (OKS) to cut expenditure. We evaluate these criteria by assessing the cost-effectiveness of TKR compared with no knee replacement for patients with different baseline characteristics from an NHS perspective.
Design
The cost-effectiveness of TKR in different patient subgroups was assessed using regression analyses of patient-level data from the Knee Arthroplasty Trial, a large, pragmatic randomised trial comparing knee prostheses.
Setting
34 UK hospitals.
Participants
2131 osteoarthritis patients undergoing TKR.
Interventions and outcome measures
Costs and quality-adjusted life years (QALYs) observed in the Knee Arthroplasty Trial within 5 years of TKR were compared with conservative assumptions about the costs and outcomes that would have been accrued had TKR not been performed.
Results
On average, primary TKR and 5 years of subsequent care cost £7458 per patient (SD: £4058), and patients gained an average of 1.33 (SD: 1.43) QALYs. As a result, TKR cost £5623/QALY gained. Although costs and health outcomes varied with age and sex, TKR cost <£20 000/QALY gained for patients with American Society of Anaesthesiologists grades 1–2 who had baseline OKS <40 and for American Society of Anaesthesiologists grade 3 patients with OKS <35, even with highly conservative assumptions about costs and outcomes without TKR. Body mass index had no significant effect on costs or outcomes. Restricting TKR to patients with pre-operative OKS <27 would inappropriately deny a highly cost-effective treatment to >10 000 patients annually.
Conclusions
TKR is highly cost-effective for most current patients if the NHS is willing to pay £20 000–£30 000/QALY gained. At least 97% of TKR patients in England have more severe symptoms than the thresholds we have identified, suggesting that further rationing by OKS is probably unjustified.
Trial registration number
ISRCTN 45837371.
Article summary
Article focus
We assess the cost-effectiveness of total knee replacement (TKR) compared with no knee replacement for patients with different baseline characteristics from a NHS perspective.
In particular, we assess the appropriateness of eligibility criteria recently introduced by many UK primary care trusts, which restrict TKR to patients with low (ie, poor) pre-operative Oxford Knee Scores (OKS) to cut expenditure.
Key messages
We find TKR to be highly cost-effective, costing £5623 per quality-adjusted life year gained for the average patient.
TKR costs <£20 000 per quality-adjusted life year gained for healthy patients with OKS of <40 or <35 for patients who have other conditions restricting their daily activities.
We find no evidence to support the criteria for restricting access to TKR that have been proposed by some primary care trusts and calculate that restricting TKR to those patients with pre-operative OKS of 26 or less would deny a highly cost-effective treatment to >10 000 patients/year.
Strengths and limitations of this study
This is the first study assessing how the cost-effectiveness of TKR varies with OKS and the first assessing the clinical/economic implications of the newly introduced rationing criteria.
Analyses are based on patient-level data from a large pragmatic trial with detailed prospective collection of utilities, baseline characteristics and all major knee-related NHS resource use, including revisions and ambulatory care.
Our study makes several highly conservative assumptions: in particular, assuming that patients would have accrued no knee-related costs and remained at baseline utility without TKR. Furthermore, the Knee Arthroplasty Trial sample included only 37 patients with pre-operative OKS >35. As result, TKR may be also cost-effective for some patients with OKS above 39.
doi:10.1136/bmjopen-2011-000332
PMCID: PMC3269047  PMID: 22290396
4.  Physiotherapy Rehabilitation After Total Knee or Hip Replacement 
Executive Summary
Objective
The objective of this health technology policy analysis was to determine, where, how, and when physiotherapy services are best delivered to optimize functional outcomes for patients after they undergo primary (first-time) total hip replacement or total knee replacement, and to determine the Ontario-specific economic impact of the best delivery strategy. The objectives of the systematic review were as follows:
To determine the effectiveness of inpatient physiotherapy after discharge from an acute care hospital compared with outpatient physiotherapy delivered in either a clinic-based or home-based setting for primary total joint replacement patients
To determine the effectiveness of outpatient physiotherapy delivered by a physiotherapist in either a clinic-based or home-based setting in addition to a home exercise program compared with a home exercise program alone for primary total joint replacement patients
To determine the effectiveness of preoperative exercise for people who are scheduled to receive primary total knee or hip replacement surgery
Clinical Need
Total hip replacements and total knee replacements are among the most commonly performed surgical procedures in Ontario. Physiotherapy rehabilitation after first-time total hip or knee replacement surgery is accepted as the standard and essential treatment. The aim is to maximize a person’s functionality and independence and minimize complications such as hip dislocation (for hip replacements), wound infection, deep vein thrombosis, and pulmonary embolism.
The Therapy
The physiotherapy rehabilitation routine has 4 components: therapeutic exercise, transfer training, gait training, and instruction in the activities of daily living. Physiotherapy rehabilitation for people who have had total joint replacement surgery varies in where, how, and when it is delivered. In Ontario, after discharge from an acute care hospital, people who have had a primary total knee or hip replacement may receive inpatient or outpatient physiotherapy. Inpatient physiotherapy is delivered in a rehabilitation hospital or specialized hospital unit. Outpatient physiotherapy is done either in an outpatient clinic (clinic-based) or in the person’s home (home-based). Home-based physiotherapy may include practising an exercise program at home with or without supplemental support from a physiotherapist.
Finally, physiotherapy rehabilitation may be administered at several points after surgery, including immediately postoperatively (within the first 5 days) and in the early recovery period (within the first 3 months) after discharge. There is a growing interest in whether physiotherapy should start before surgery. A variety of practises exist, and evidence regarding the optimal pre- and post-acute course of rehabilitation to obtain the best outcomes is needed.
Review Strategy
The Medical Advisory Secretariat used its standard search strategy, which included searching the databases of Ovid MEDLINE, CINHAL, EMBASE, Cochrane Database of Systematic Reviews, and PEDro from 1995 to 2005. English-language articles including systematic reviews, randomized controlled trials (RCTs), non-RCTs, and studies with a sample size of greater than 10 patients were included. Studies had to include patients undergoing primary total hip or total knee replacement, aged 18 years of age or older, and they had to have investigated one of the following comparisons: inpatient rehabilitation versus outpatient (clinic- or home-based therapy) rehabilitation, land-based post-acute care physiotherapy delivered by a physiotherapist compared with patient self-administered exercise and a land-based exercise program before surgery. The primary outcome was postoperative physical functioning. Secondary outcomes included the patient’s assessment of therapeutic effect (overall improvement), perceived pain intensity, health services utilization, treatment side effects, and adverse events
The quality of the methods of the included studies was assessed using the criteria outlined in the Cochrane Musculoskeletal Injuries Group Quality Assessment Tool. After this, a summary of the biases threatening study validity was determined. Four methodological biases were considered: selection bias, performance bias, attrition bias, and detection bias. A meta-analysis was conducted when adequate data were available from 2 or more studies and where there was no statistical or clinical heterogeneity among studies. The GRADE system was used to summarize the overall quality of evidence.
Summary of Findings
The search yielded 422 citations; of these, 12 were included in the review including 10 primary studies (9 RCTs, 1 non-RCT) and 2 systematic reviews.
The Medical Advisory Secretariat review included 2 primary studies (N = 334) that examined the effectiveness of an inpatient physiotherapy rehabilitation program compared with an outpatient home-based physiotherapy program on functional outcomes after total knee or hip replacement surgery. One study, available only as an abstract, found no difference in functional outcome at 1 year after surgery (TKR or THR) between the treatments. The other study was an observational study that found that patients who are younger than 71 years of age on average, who do not live alone, and who do not have comorbid illnesses recover adequate function with outpatient home-based physiotherapy. However results were only measured up to 3 months after surgery, and the outcome measure they used is not considered the best one for physical functioning.
Three primary studies (N = 360) were reviewed that tested the effectiveness of outpatient home-based or clinic-based physiotherapy in addition to a self-administered home exercise program, compared with a self-administered exercise program only or in addition to using another therapy (phone calls or continuous passive movement), on postoperative physical functioning after primary TKR surgery. Two of the studies reported no difference in change from baseline in flexion range of motion between those patients receiving outpatient or home-based physiotherapy and doing a home exercise program compared with patients who did a home exercise program only with or without continuous passive movement. The other study reported no difference in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) scores between patients receiving clinic-based physiotherapy and practising a home exercise program and those who received monitoring phone calls and did a home exercise program after TKR surgery.
The Medical Advisory Secretariat reviewed two systematic reviews evaluating the effects of preoperative exercise on postoperative physical functioning. One concluded that preoperative exercise is not effective in improving functional recovery or pain after TKR and any effects after THR could not be adequately determined. The other concluded that there was inconclusive evidence to determine the benefits of preoperative exercise on functional recovery after TKR. Because 2 primary studies were added to the published literature since the publication of these systematic reviews the Medical Advisory Secretariat revisited the question of effectiveness of a preoperative exercise program for patients scheduled for TKR ad THR surgery.
The Medical Advisory Secretariat also reviewed 3 primary studies (N = 184) that tested the effectiveness of preoperative exercise beginning 4-6 weeks before surgery on postoperative outcomes after primary TKR surgery. All 3 studies reported negative findings with regard to the effectiveness of preoperative exercise to improve physical functioning after TKR surgery. However, 2 failed to show an effect of the preoperative exercise program before surgery in those patients receiving preoperative exercise. The third study did not measure functional outcome immediately before surgery in the preoperative exercise treatment group; therefore the study’s authors could not document an effect of the preoperative exercise program before surgery. Regarding health services utilization, 2 of the studies did not find significant differences in either the length of the acute care hospital stay or the inpatient rehabilitation care setting between patients treated with a preoperative exercise program and those not treated. The third study did not measure health services utilization.
These results must be interpreted within the limitations and the biases of each study. Negative results do not necessarily support a lack of treatment effect but may be attributed to a type II statistical error.
Finally, the Medical Advisory Secretariat reviewed 2 primary studies (N = 136) that examined the effectiveness of preoperative exercise on postoperative functional outcomes after primary THR surgery. One study did not support the effectiveness of an exercise program beginning 8 weeks before surgery. However, results from the other did support the effectiveness of an exercise program 8 weeks before primary THR surgery on pain and functional outcomes 1 week before and 3 weeks after surgery.
Conclusions
Based on the evidence, the Medical Advisory Secretariat reached the following conclusions with respect to physiotherapy rehabilitation and physical functioning 1 year after primary TKR or THR surgery:
There is high-quality evidence from 1 large RCT to support the use of home-based physiotherapy instead of inpatient physiotherapy after primary THR or TKR surgery.
There is low-to-moderate quality evidence from 1 large RCT to support the conclusion that receiving a monitoring phone call from a physiotherapist and practising home exercises is comparable to receiving clinic-based physiotherapy and practising home exercises for people who have had primary TKR surgery. However, results may not be generalizable to those who have had THR surgery.
There is moderate evidence to suggest that an exercise program beginning 4 to 6 weeks before primary TKR surgery is not effective.
There is moderate evidence to support the effectiveness of an exercise program beginning 8 weeks before surgery to improve physical functioning 3 weeks after THR surgery.
PMCID: PMC3382414  PMID: 23074477
5.  Surgery for Fractured Neck of Femur – are Patients Adequately Consented? 
INTRODUCTION
Obtaining valid consent is a legal and ethical obligation when performing any procedure in clinical practice. This study was performed to identify the validity and effectiveness of the new consent form and any potential improvement that could be made when taking consent.
PATIENTS AND METHODS
Case notes of 173 patients undergoing surgery for fractured neck of femur were retrospectively reviewed. Risks and complications of the surgery as listed on the consent form were noted. Sixty-five cases were excluded from the study as they had either old consent forms with no risks recorded or a consent form signed by a consultant due to patient inability to consent. Six of the consent forms could not be located in the notes. This left 102 consent forms to be analysed.
RESULTS
The number of risks documented on each form ranged from 0–8 (mean, 3.92). No risks were recorded in 2 of these 102 forms. Most commonly recorded risks were infection (95.1%), DVT/PE (81.4%) and failure of procedure (59.8%). It was shown that many of the consent forms analysed did not have all the serious or frequently occurring risks recorded on them and that a large proportion of the forms had acronyms or phrases that may mean nothing to the patient. Comparison of documented risks for different hip surgery were made using Fisher's exact test showing no significant difference between the risks recorded on the forms for each type of procedure.
CONCLUSIONS
Although documentation of risks has been improved compared to old consent forms, patients are not necessarily given the most appropriate information to ensure consent is valid. Further refining of consent forms may be necessary to ensure that all major risks are explained and understood by patients and that there is satisfactory recording of this information.
doi:10.1308/003588407X160846
PMCID: PMC1963537  PMID: 17316526
Consent forms; Fracture; Neck of femur; Hip surgery
6.  Consenting for pelvic nerve injury in colorectal surgery: need to address age and gender bias 
INTRODUCTION
Pelvic nerve injury is a recognised complication following pelvic dissection in colorectal surgery. It can lead to urinary and sexual dysfunction in men and women, which varies from 5-40% depending on the surgery and the underlying pathology. Sexual dysfunction can manifest as erectile dysfunction in men and as dyspareunia and failure to achieve sexual arousal/orgasm in women. The aim of this study was to evaluate consent for these complications prior to surgery.
PATIENTS AND METHODS
We carried out a retrospective audit on patients who had undergone elective colorectal surgery involving pelvic dissection over a 2-year period (June 2006 to June 2008) at University Hospital of North Staffordshire. We reviewed the consent forms and medical records of these patients, specifically looking for documentation of pelvic nerve injury, sexual dysfunction or erectile dysfunction prior to surgery. Only patients who had documented pelvic dissection in their operative notes were included in the audit, and those who were deemed unable to consent were excluded.
RESULTS
Medical records of 118 patients were reviewed. Of this cohort, 31% were women (n = 37). Malignancy was the indication for surgery in 79% of women and 88% of men. Consent for the procedure was obtained by a consultant in 73% (n = 86) of patients and by a middle-grade surgeon in the remaining 27% (n = 32). Only two women were consented for pelvic nerve injury whilst this number was 41 for men (5% vs 51%). Patients younger than 50 years were more consistently informed of the risks (50%) compared to the over 50-year-olds (34%). Only eight patients (males 6, females 2) were consented for urinary dysfunction.
CONCLUSIONS
The risk of pelvic nerve injury is not frequently stated, which is more common in women and the elderly. Overall, only 36% of patients were consented for pelvic nerve injury, while only 5% of women were consented. Is this professional discretion, or evidence that surgeons are not being assiduous enough when obtaining consent, which may leave them vulnerable to medicolegal claims? Introduction of procedure-specific consent forms would be a method to address this issue.
doi:10.1308/003588410X12628812459779
PMCID: PMC3180310  PMID: 20487592
Pelvic nerve injury; Sexual dysfunction; Colorectal surgery; Gender bias; Surgical consent
7.  Lower limb orthopaedic surgery results in changes to coagulation and non-specific inflammatory biomarkers, including selective clinical outcome measures 
Background
With an aging society and raised expectations, joint replacement surgery is likely to increase significantly in the future. The development of postoperative complications following joint replacement surgery (for example, infection, systemic inflammatory response syndrome and deep vein thrombosis) is also likely to increase. Despite considerable progress in orthopaedic surgery, comparing a range of biological markers with the ultimate aim of monitoring or predicting postoperative complications has not yet been extensively researched. The aim of this clinical pilot study was to test the hypothesis that lower limb orthopaedic surgery results in changes to coagulation, non-specific markers of inflammation (primary objective) and selective clinical outcome measures (secondary objective).
Methods
Test subjects were scheduled for elective total hip replacement (THR) or total knee replacement (TKR) orthopaedic surgery due to osteoarthritis (n = 10). Platelet counts and D-dimer concentrations were measured to assess any changes to coagulation function. C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were measured as markers of non-specific inflammation. Patients were monitored regularly to assess for any signs of postoperative complications, including blood transfusions, oedema (knee swelling), wound infection, pain and fever.
Results
THR and TKR orthopaedic surgery resulted in similar changes of coagulation and non-specific inflammatory biomarkers, suggestive of increased coagulation and inflammatory reactions postoperatively. Specifically, THR and TKR surgery resulted in an increase in platelet (P = 0.013, THR) and D-dimer (P = 0.009, TKR) concentrations. Evidence of increased inflammation was demonstrated by an increase in CRP and ESR (P ≤ 0.05, THR and TKR). Four patients received blood transfusions (two THR and two TKR patients), with maximal oedema, pain and aural temperatures peaking between days 1 and 3 postoperatively, for both THR and TKR surgery. None of the patients developed postoperative infections.
Conclusions
The most noticeable changes in biological markers occur during days 1 to 3 postoperatively for both THR and TKR surgery, and these may have an effect on such postoperative clinical outcomes as oedema, pyrexia and pain. This study may assist in understanding the postoperative course following lower limb orthopaedic surgery, and may help clinicians in planning postoperative management and patient care.
doi:10.1186/2047-783X-18-40
PMCID: PMC3832226  PMID: 24206644
Coagulation; Inflammation; Orthopaedic surgery
8.  Postal consent for upper gastrointestinal endoscopy 
Gut  2000;46(1):37-39.
BACKGROUND—Standards for good practice in clinical risk management issued by the Clinical Negligence Scheme for Trusts indicate that "appropriate information is provided to patients on the risks and benefits of proposed treatment, and of the alternatives available before a signature on a consent form is sought".
AIMS—To investigate the practicability and patient acceptability of a postal information and consent booklet for patients undergoing outpatient gastroscopy.
METHODS—Information about gastroscopy procedure, personalised appointment details, and a carbonised consent form were compiled into a single booklet. This was mailed to patients well in advance of their endoscopic procedure. Patient satisfaction for this new process was assessed by questionnaire.
RESULTS—275 patients received a patient information booklet. Of these, 150 (54.5%) returned the consent form by post when they confirmed their attendance; 141 (94%) had signed the form, and the other nine requested further information. Of the remaining 125 booklets sent out, 115 (92%) forms were brought back on the day of the investigation having been previously signed. The remaining 10 (8%) required further information before signing the form. An audit of 168 patients was used to test reaction to the booklet and the idea of filling in the form before coming to hospital; 155 patients (92.2%) reported the information given in the booklet to be "very useful", and all reported it to be "clear and understandable".
CONCLUSION—A specifically designed patient information booklet with integral consent form is accepted by patients, and improves the level of understanding prior to the investigation being carried out.


Keywords: consent; endoscopy; gastroscopy
doi:10.1136/gut.46.1.37
PMCID: PMC1727779  PMID: 10601052
9.  Arthroscopic Lavage and Debridement for Osteoarthritis of the Knee 
Executive Summary
Objective
The purpose of this review was to determine the effectiveness and adverse effects of arthroscopic lavage and debridement, with or without lavage, in the treatment of symptoms of osteoarthritis (OA) of the knee, and to conduct an economic analysis if evidence for effectiveness can be established.
Questions Asked
Does arthroscopic lavage improve motor function and pain associated with OA of the knee?
Does arthroscopic debridement improve motor function and pain associated with OA of the knee?
If evidence for effectiveness can be established, what is the duration of effect?
What are the adverse effects of these procedures?
What are the economic considerations if evidence for effectiveness can be established?
Clinical Need
Osteoarthritis, the most common rheumatologic musculoskeletal disorder, affects about 10% of the Canadian adult population. Although the natural history of OA is not known, it is a degenerative condition that affects the bone cartilage in the joint. It can be diagnosed at earlier ages, particularly within the sports injuries population, though the prevalence of non-injury-related OA increases with increasing age and varies with gender, with women being twice as likely as men to be diagnosed with this condition. Thus, with an aging population, the impact of OA on the health care system is expected to be considerable.
Treatments for OA of the knee include conservative or nonpharmacological therapy, like physiotherapy, weight management and exercise; and more generally, intra-articular injections, arthroscopic surgery and knee replacement surgery. Whereas knee replacement surgery is considered an end-of-line intervention, the less invasive surgical procedures of lavage or debridement may be recommended for earlier and more severe disease. Both arthroscopic lavage and debridement are generally indicated in patients with knee joint pain, with or without mechanical problems, that are refractory to medical therapy. The clinical utility of these procedures is unclear, hence, the assessment of their effectiveness in this review.
Lavage and Debridement
Arthroscopic lavage involves the visually guided introduction of saline solution into the knee joint and removal of fluid, with the intent of extracting any excess fluids and loose bodies that may be in the knee joint. Debridement, in comparison, may include the introduction of saline into the joint, in addition to the smoothening of bone surface without any further intervention (less invasive forms of debridement), or the addition of more invasive procedures such as abrasion, partial or full meniscectomy, synovectomy, or osteotomy (referred to as debridement in combination with meniscectomy or other procedures). The focus of this health technology assessment is on the effectiveness of lavage, and debridement (with or without meniscal tear resection).
Review Strategy
The Medical Advisory Secretariat followed its standard procedures and searched these electronic databases: Ovid MEDLINE, EMBASE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews and The International Network of Agencies for Health Technology Assessment.
The keywords searched were: arthroscopy, debridement, lavage, wound irrigation, or curettage; arthritis, rheumatoid, osteoarthritis; osteoarthritis, knee; knee or knee joint.
Time frame: Only 2 previous health technology assessments were identified, one of which was an update of the other, and included 3 of 4 randomized controlled trials (RCTs) from the first report. Therefore, the search period for inclusion of studies in this assessment was January 1, 1995 to April 24, 2005.
Excluded were: case reports, comments, editorials, and letters. Identified were 335 references, including previously published health technology assessments, and 5 articles located through a manual search of references from published articles and health technology assessments. These were examined against the criteria, as described below, which resulted in the inclusion of 1 health technology assessment and its corresponding update, and 4 articles (2 RCTs and 2 level 4 studies) for arthroscopic lavage and 8 papers (2 RCTs and 6 level 4 studies) for arthroscopic debridement.
Inclusion Criteria
English-language articles from PubMed, EMBASE, Cochrane Systematic Reviews, and health technology assessments from January 1, 1995 onward
Studies on OA of the knee with a focus on the outcomes of motor function and pain
Studies of arthroscopic procedures only
Studies in which meniscal tear resection/meniscectomy (partial or full) has been conducted in conjunction with lavage or debridement.
Exclusion Criteria
Studies that focus on inflammatory OA, joint tuberculosis, septic joints, psoriatic joints (e.g., psoriatic knee joint synovitis), synovitis, chondropathy of the knee and gonarthrosis (which includes varotic gonarthrosis)
Studies that focus on rheumatoid arthritis
Studies that focus on meniscal tears from an acute injury (e.g., sports injury)
Studies that are based on lavage or debridement for microfracture of the knee
Studies in which other surgical procedures (e.g., high tibial osteotomy, synovectomy, have been conducted in addition to lavage/debridement)
Studies based on malalignment of the knee (e.g., varus/valgus arthritic conditions).
Studies that compare lavage to lavage plus drug therapy
Studies on procedures that are not arthroscopic (i.e., visually guided) (e.g., nonarthroscopic lavage)
Studies of OA in children.
Intervention
Arthroscopic lavage or debridement, with or without meniscectomy, for the treatment of motor function symptoms and pain associated with OA of the knee.
Comparators
Studies in which there was a comparison group of either diseased or healthy subjects or one in which subjects were their own control were included. Comparisons to other treatments included placebo (or sham) arthroscopy. Sham arthroscopy involved making small incisions and manipulating the knee, without the insertion of instruments.
Summary of Findings
In early OA of the knee with pain refractory to medical treatment, there is level 1b evidence that:
Arthroscopic lavage gives rise to a statistically significant, but not clinically meaningful effect in improving pain (WOMAC pain and VAS pain) up to 12 months following surgery. The effect on joint function (WOMAC function) and the primary outcome (WOMAC aggregate) was neither statistically nor clinically significant.
In moderate or severe OA of the knee with pain refractory to medical treatment, there is:
Level 1b evidence that the effect on pain and function of arthroscopic lavage (10 L saline) and debridement (with 10 L saline lavage) is not statistically significant up to 24 months following surgery.
Level 2 evidence that arthroscopic debridement (with 3 L saline lavage) is effective in the control of pain in severe OA of the medial femoral condyle for up to 5 years.
For debridement in combination with meniscectomy, there is level 4 evidence that the procedure, as appropriate, might be effective in earlier stages, unicompartmental disease, shorter symptom duration, sudden onset of mechanical symptoms, and preoperative full range of motion. However, as these findings are derived from very poor quality evidence, the identification of subsets of patients that may benefit from this procedure requires further testing.
In patients with pain due to a meniscal tear, of the medial compartment in particular, repair of the meniscus results in better pain control at 2 years following surgery than if the pain is attributable to other causes. There is insufficient evidence to comment on the effectiveness of lateral meniscus repair on pain control.
Conclusions
Arthroscopic debridement of the knee has thus far only been found to be effective for medial compartmental OA. All other indications should be reviewed with a view to reducing arthroscopic debridement as an effective therapy.
Arthroscopic lavage of the knee is not indicated for any stage of OA.
There is very poor quality evidence on the effectiveness of debridement with partial meniscectomy in the case of meniscal tears in OA of the knee.
PMCID: PMC3382413  PMID: 23074463
10.  A Randomised Trial of Conventional versus BAUS Procedure-Specific Consent Forms for Transurethral Resection of Prostate 
INTRODUCTION
Conventional consent forms often contain incomplete information regarding risks associated with invasive procedures. BAUS has introduced procedure-specific consent forms (PSCF) documenting the risks associated with urological procedures. We compared patients' understanding of the risks and benefits of TURP after the consenting process with either conventional documentation or PSCF.
PATIENTS AND METHODS
One hundred patients were randomised to be consented with either a conventional or PSCF. After 3 h, their understanding was assessed with a questionnaire asking patients to document the indication and likelihood of symptomatic improvement, estimate frequency of complications and the risk of future re-operation. Data were compared by Mann–Whitney test.
RESULTS
Fifty patients were randomised to each group. There was no significant difference in mean age, grade of doctor obtaining consent or time interval from consent to questionnaire. Both groups accurately predicted the chance of improved symptoms (median, 80%). There was no significant difference in patients' median estimation of risk of complications such as incontinence, erectile dysfunction, or retrograde ejaculation. Patients consented with the PSCF predicted the risk of re-operation more accurately (median answer, 10% versus 30%; P = 0.007, Mann–Whitney test).
CONCLUSIONS
Recall of data was sub-optimal in both groups. For most data points there was no significant difference in estimation of risks between groups. Those consented with a procedure-specific consent form predicted risk of re-operation at 10 years more accurately. Procedure-specific consent forms offer an advantage over conventional consent in this study. We feel that the provision of a written structured framework allows better informed consent for TURP.
doi:10.1308/003588409X359277
PMCID: PMC2765012  PMID: 19220941
BPH; Informed consent; TURP
11.  Consent to surgery in a high risk specialty: a prospective audit. 
A prospective audit was performed to assess how well patients were being consented for neurosurgery. Sixty patients with various neurosurgical conditions were included in the study. Audit was performed firstly by means of a questionnaire to examine the type of information given to patients, and their understanding of such information. Secondly, the patient's medical notes were reviewed to analyse any written evidence by the consenting doctor for the consenting procedure. 100% of the patients felt that they had been informed satisfactorily about the nature of their condition and the nature of the operation. 92% understood the specific risks of their proposed operation. However, only 25% were informed about the general risks of surgery and anaesthesia. Only 33% felt that they were informed fully about alternative treatment options. 97% of the patients felt that they had reached an informed decision regarding surgery. 67% of the case notes contained information on the nature and specific risks of the operation, while information on general risks of surgery and anaesthesia was documented in only 17% of the case notes. 33% of the case notes contained no information for the consenting procedure. Our audit showed that the patients had a good understanding of the nature and aim of the operation and the specific risks. Areas that require improvement are explaining the general risks of surgery and alternative treatment. For the consenting doctor, there should be more documentation in the notes, and there should be mention of the doctor's satisfaction that the patient was deemed to be competent and had made an informed decision.
PMCID: PMC2503427  PMID: 10858689
12.  Hip and knee replacement patients prefer pen-and-paper questionnaires 
Bone & Joint Research  2013;2(11):238-244.
Objectives
Electronic forms of data collection have gained interest in recent years. In orthopaedics, little is known about patient preference regarding pen-and-paper or electronic questionnaires. We aimed to determine whether patients undergoing total hip (THR) or total knee replacement (TKR) prefer pen-and-paper or electronic questionnaires and to identify variables that predict preference for electronic questionnaires.
Methods
We asked patients who participated in a multi-centre cohort study investigating improvement in health-related quality of life (HRQoL) after THR and TKR using pen-and-paper questionnaires, which mode of questionnaire they preferred. Patient age, gender, highest completed level of schooling, body mass index (BMI), comorbidities, indication for joint replacement and pre-operative HRQoL were compared between the groups preferring different modes of questionnaire. We then performed logistic regression analyses to investigate which variables independently predicted preference of electronic questionnaires.
Results
A total of 565 THR patients and 387 TKR patients completed the preference question. Of the THR patients, 81.8% (95% confidence interval (CI) 78.4 to 84.7) preferred pen-and-paper questionnaires to electronic questionnaires, as did 86.8% (95% CI 83.1 to 89.8) of TKR patients. Younger age, male gender, higher completed level of schooling and higher BMI independently predicted preference of electronic questionnaires in THR patients. Younger age and higher completed level of schooling independently predicted preference of electronic questionnaires in TKR patients.
Conclusions
The majority of THR and TKR patients prefer pen-and-paper questionnaires. Patients who preferred electronic questionnaires differed from patients who preferred pen-and-paper questionnaires. Restricting the mode of patient-reported outcome measures to electronic questionnaires might introduce selection bias.
Cite this article: Bone Joint Res 2013;2:238–44.
doi:10.1302/2046-3758.211.2000219
PMCID: PMC3834769  PMID: 24203164
Health-related quality of life; Total hip replacement; Total knee replacement; Patient-reported outcome measure; PROM; Questionnaire mode
13.  The Warwick patellofemoral arthroplasty trial: a randomised clinical trial of total knee arthroplasty versus patellofemoral arthroplasty in patients with severe arthritis of the patellofemoral joint 
Background
Severe arthritis of the knee is a disabling condition, with over 50,000 knee replacements performed each year in the UK. Isolated patellofemoral joint arthritis occurs in over 10% of these patients with the treatment options being patellofemoral arthroplasty or total knee arthroplasty. Whilst many surgeons believe total knee arthroplasty is the 'gold standard' treatment for severe knee arthritis, patellofemoral arthroplasty has certain potential advantages. Primarily, because this operation allows the patient to keep the majority of their own knee joint; preserving bone-stock and the patients' own ligaments. Patellofemoral arthroplasty has also been recognised as a less 'invasive' operation than primary total knee arthroplasty, facilitating a more rapid recovery. There are currently no published results of randomised clinical trials comparing the two arthroplasty techniques. The primary objective of the current study is to assess whether there is a difference in functional knee scores and quality of life outcome assessments at one year post-operation between patellofemoral arthroplasty and total knee arthroplasty. The secondary objective is to assess the complication rates for both procedures.
Methods/design
Patients who are deemed suitable, by an Orthopaedic Consultant, for patellofemoral arthroplasty and medically fit for surgery are eligible to take part in this trial. The consenting patients will be randomised in a 1:1 allocation to a total knee or patellofemoral arthroplasty. The randomisation sequence will be computer generated and administered by a central independent randomisation service. Following consent, all participants will have their knee function, quality of life and physical activity level assessed through questionnaires. The assigned surgery will then be performed using the preferred technique and implant of the operating surgeon. The first post-operative assessments will take place at six weeks, followed by further assessments at 3, 6 and 12 months. At each assessment time point all complications will be recorded. In addition, community and social care services usage will be collected using a patient questionnaire at 3, 6 & 12 months. The patients will then be sent an annual postal questionnaire. The questionnaire will ask about any problems, knee pain and function following their knee arthroplasty to monitor long-term function and failure rates.
Discussion
This trial is expected to deliver results in early 2013.
Trial Registration
ISRCTN: ISRCTN34863373
UKCRN portfolio ID 6847
doi:10.1186/1471-2474-12-265
PMCID: PMC3235978  PMID: 22111771
14.  Pre-surgical radiologic identification of peri-prosthetic osteolytic lesions around TKRs: a pre-clinical investigation of diagnostic accuracy 
Background
Emerging longitudinal data appear to demonstrate an alarming trend towards an increasing prevalence of osteolysis-induced mechanical failure, following total knee replacement (TKR). Even with high-quality multi-plane X-rays, accurate pre-surgical evaluation of osteolytic lesions is often difficult. This is likely to have an impact on surgical management and provides reasonable indication for the development of a model allowing more reliable lesion assessment. The aim of this study, using a simulated cadaver model, was to explore the accuracy of rapid spiral computed tomography (CT) examination in the non-invasive evaluation of peri-prosthetic osteolytic lesions, secondary to TKR, and to compare this to conventional X-ray standards.
Methods
A series of nine volume-occupying defects, simulating osteolytic lesions, were introduced into three human cadaveric knees, adjacent to the TKR implant components. With implants in situ, each knee was imaged using a two-stage conventional plain X-ray series and rapid-acquisition spiral CT. A beam-hardening artefact removal algorithm was employed to improve CT image quality.
After random image sorting, 12 radiologists were independently shown the series of plain X-ray images and asked to note the presence, anatomic location and 'size' of osteolytic lesions observed. The same process was repeated separately for review of the CT images. The corresponding X-ray and CT responses were directly compared to elicit any difference in the ability to demonstrate the presence and size of osteolytic lesions.
Results
Access to CT images significantly improved the accuracy of recognition of peri-prosthetic osteolytic lesions when compared to AP and lateral projections alone (P = 0.008) and with the addition of bi-planar oblique X-rays (P = 0.03). No advantage was obtained in accuracy of identification of such lesions through the introduction of the oblique images when compared with the AP and lateral projections alone (P = 0.13)
Conclusion
The findings of this study suggest that peri-prosthetic osteolytic lesions can be reliably described non-invasively using a simple, rapid-acquisition CT-based imaging approach. The low sensitivity of conventional X-ray, even with provision of supplementary bi-planar 45° oblique views, suggests a limited role for use in situ for TKR implant screening where peri-prosthetic osteolytic lesions are clinically suspected. In contrast, the accuracy of CT evaluation, linked to its procedural ease and widespread availability, may provide a more accurate way of evaluating osteolysis around TKRs, at routine orthopaedic follow up. These findings have direct clinical relevance, as accurate early recognition and classification of such lesions influences the timing and aggressiveness of surgical and non-operative management strategies, and also the nature and appropriateness of planned implant revision or joint-salvaging osteotomy procedures.
doi:10.1186/1749-799X-3-47
PMCID: PMC2570664  PMID: 18834525
15.  Audit on the Efficient Use of Cross-Matched Blood in Elective Total Hip and Total Knee Replacement 
INTRODUCTION
This prospective audit studies the use of cross-matched blood in 301 patients over a 1-year period undergoing total knee (TKR) and total hip replacement (THR) surgery in an orthopaedic unit.
PATIENTS AND METHODS
Analysis over the first 6 months revealed a high level of unnecessary cross-matched blood. The following interventions were introduced: (i) to cease routine cross-matching for THR; (ii) all patients to have a check full blood count on day 2 after surgery; and (iii) Hb < 8 g/dl to be considered as the trigger for transfusion in patients over 65 years and free from significant co-morbidity. These changes are in accordance with published national guidelines [Anon. Guidelines for the clinical use of red cell transfusions. Br J Haematol 2001; 113: 24–31].
RESULTS
In the next 6 months, the number of units cross-matched but not transfused fell by 96% for THR, and the cross-match transfusion (C:T) ratio reduced from 3.21 to 1.62. Reductions were also observed for the TKR cohort. These results provide evidence of a substantial risk and cost benefit in the use of this limited resource. A telephone survey of 44 hospitals revealed that 20 hospitals routinely cross-matched blood for THR and 11 do so for TKR.
CONCLUSIONS
Changes can be made to the Maximum Surgical Blood Ordering Schedules (MSBOS) in other orthopaedic units according to national guidelines.
doi:10.1308/003588406X82952
PMCID: PMC1964061  PMID: 16551419
Total hip replacement; Total knee replacement; Cross-match transfusion ratio (C/T); Maximum Surgical Blood Ordering Schedule (MSBOS)
16.  Variability of indication criteria in knee and hip replacement: an observational study 
Background
Total knee (TKR) and hip (THR) replacement (arthroplasty) are effective surgical procedures that relieve pain, improve patients' quality of life and increase functional capacity. Studies on variations in medical practice usually place the indications for performing these procedures to be highly variable, because surgeons appear to follow different criteria when recommending surgery in patients with different severity levels. We therefore proposed a study to evaluate inter-hospital variability in arthroplasty indication.
Methods
The pre-surgical condition of 1603 patients included was compared by their personal characteristics, clinical situation and self-perceived health status. Patients were asked to complete two health-related quality of life questionnaires: the generic SF-12 (Short Form) and the specific WOMAC (Western Ontario and Mcmaster Universities) scale. The type of patient undergoing primary arthroplasty was similar in the 15 different hospitals evaluated.
The variability in baseline WOMAC score between hospitals in THR and TKR indication was described by range, mean and standard deviation (SD), mean and standard deviation weighted by the number of procedures at each hospital, high/low ratio or extremal quotient (EQ5-95), variation coefficient (CV5-95) and weighted variation coefficient (WCV5-95) for 5-95 percentile range. The variability in subjective and objective signs was evaluated using median, range and WCV5-95. The appropriateness of the procedures performed was calculated using a specific threshold proposed by Quintana et al for assessing pain and functional capacity.
Results
The variability expressed as WCV5-95 was very low, between 0.05 and 0.11 for all three dimensions on WOMAC scale for both types of procedure in all participating hospitals. The variability in the physical and mental SF-12 components was very low for both types of procedure (0.08 and 0.07 for hip and 0.03 and 0.07 for knee surgery patients). However, a moderate-high variability was detected in subjective-objective signs. Among all the surgeries performed, approximately a quarter of them could be considered to be inappropriate.
Conclusions
A greater inter-hospital variability was observed for objective than for subjective signs for both procedures, suggesting that the differences in clinical criteria followed by surgeons when indicating arthroplasty are the main responsible factors for the variation in surgery rates.
doi:10.1186/1471-2474-11-249
PMCID: PMC2987974  PMID: 20977745
17.  Informed consent practices for surgical care at university teaching hospitals: a case in a low resource setting 
BMC Medical Ethics  2014;15:40.
Background
Informed consent in medical practice is essential and a global standard that should be sought at all the times doctors interact with patients. Its intensity would vary depending on the invasiveness and risks associated with the anticipated treatment. To our knowledge there has not been any systematic review of consent practices to document best practices and identify areas that need improvement in our setting. The objective of the study was to evaluate the informed consent practices of surgeons at University teaching Hospitals in a low resource setting.
Methods
A cross-sectional study conducted at three university teaching hospitals in Uganda. Self-guided questionnaires were left at a central location in each of the surgical departments after verbally communicating to the surgeons of the intention of the study. Filled questionnaires were returned at the same location by the respondents for collection by the research team. In addition, 20 in-depth interviews were held with surgeons and a review of 384 patients’ record files for informed consent documentation was done.
Results
A total of 132 (62.1%) out of 214 questionnaires were completed and returned. Respondents were intern doctors, residents and specialists from General surgery, Orthopedic surgery, Ear, Nose and Throat, Ophthalmology, Dentistry, Obstetrics and Gynaecology departments. The average working experience of respondents was 4.8 years (SD 4.454, range 0–39 years). 48.8% of the respondents said they obtained consent all the time surgery is done while 51.2% did not obtain consent all the time. Many of the respondents indicated that informed consent was not obtained by the surgeon who operated the patient but was obtained either at admission or by nurses in the surgical units. The consent forms used in the hospitals were found to be inadequate and many times signed at admission before diagnosing the patient’s disease.
Conclusions
Informed consent administration and documentation for surgical health care is still inadequate at University teaching hospitals in Uganda.
doi:10.1186/1472-6939-15-40
PMCID: PMC4068318  PMID: 24885609
Informed consent practices; Surgery; Uganda
18.  Inquiry into the potential value of an information pamphlet on consent to surgery to improve surgeon-patient communication 
Quality in Health Care : QHC  1998;7(2):65-69.
OBJECTIVES: To find out how patients recently undergoing surgery experienced the consenting process and the response of these patients to a pamphlet on consent to surgery. To test the reaction of health professionals to the pamphlet. DESIGN: A pilot pamphlet was produced and a questionnaire was sent to patients inquiring about their consenting experience, and how the pamphlet might have helped them through the consent procedure. A pamphlet and a questionnaire were also sent to a random sample of the health professionals serving these patients. SUBJECTS: Patients and health professionals. RESULTS: 61% of patients returned the questionnaire. Knowledge about the consent procedure was shown to be limited. 49% were unaware that they had the right to insist that the surgeon could only perform the specified operation and nothing more. 83% were unaware that they could add something in writing to the consent form before signing. 28% of health professionals returned their questionnaire, most of whom thought that the pamphlet provided a useful contribution to surgeon-patient communication. CONCLUSION: Evidence shows that patients are not well informed about consenting to surgery and further information would provide much needed guidance on understanding their role in the consent procedure. The low response from the health professional study is perhaps an indication that at present this is an issue which is not seen as a priority.
PMCID: PMC2483596  PMID: 10180792
19.  Relationship between cutting errors and learning curve in computer-assisted total knee replacement 
International Orthopaedics  2009;34(5):655-662.
Computer-assisted total knee replacement (TKR) has been shown to improve radiographic alignment. Continuous feedback from the navigation system allows accurate adjustment of the bone cuts, thus reducing errors. The aim of this study was to determine the impact of experience both with computer navigation and knee replacement surgery on the frequency of errors in intraoperative bone cuts and implant alignment. Three homogeneous patient groups undergoing computer assisted TKR were included in the study. Each group was treated by one of three surgeons with varying experience in computer-aided and knee replacement surgery. Surgeon A had extensive experience in knee replacement and computer-assisted surgery. Surgeon B was an experienced knee replacement surgeon. A general orthopaedic surgeon with limited knee replacement surgery experience performed all surgeries in group C. The cutting errors and the number of re-cuts were determined intraoperatively. The complications and mean surgical time were collected for each group. The postoperative frontal femoral component angle, frontal tibial component angle, hip–knee–ankle angle and component slopes were evaluated. The results showed that the number of cutting errors were lowest for TKR performed by the surgeon with experience in navigation. This difference was statistically significant when compared to the general orthopaedic surgeon. A statistically significant superior result was achieved in final mechanical axis alignment for the surgeon experienced in computer-guided surgery compared to the other two groups (179.3° compared to 178.9° and 178.1°). However, the total number of outliers was similar, with no statistically significant differences among the three surgeons. Experience with navigation significantly reduced the surgical time.
doi:10.1007/s00264-009-0816-z
PMCID: PMC2903159  PMID: 19513711
20.  Total or Partial Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial 
Trials  2013;14:292.
Background
In the majority of patients with osteoarthritis of the knee the disease originates in the medial compartment. There are two fundamentally different approaches to knee replacement for patients with unicompartmental disease: some surgeons feel that it is always best to replace both the knee compartments with a total knee replacement (TKR); whereas others feel it is best to replace just the damaged component of the knee using a partial or unicompartment replacement (UKR). Both interventions are established and well-documented procedures. Little evidence exists to prove the clinical and cost-effectiveness of either management option. This provides an explanation for the high variation in treatment of choice by individual surgeons for the same knee pathology.
The aim of the TOPKAT study will be to assess the clinical and cost effectiveness of TKRs compared to UKRs in patients with medial compartment osteoarthritis.
Methods/Design
The design of the study is a single layer multicentre superiority type randomised controlled trial of unilateral knee replacement patients. Blinding will not be possible as the surgical scars for each procedure differ.
We aim to recruit 500 patients from approximately 28 secondary care orthopaedic units from across the UK including district general and teaching hospitals. Participants will be randomised to either UKR or TKR. Randomisation will occur using a web-based randomisation system. The study is pragmatic in terms of implant selection for the knee replacement operation. Participants will be followed up for 5 years. The primary outcome is the Oxford Knee Score, which will be collected via questionnaires at 2 months, 1 year and then annually to 5 years. Secondary outcomes will include cost-effectiveness, patient satisfaction and complications data.
Trial registration
Current Controlled Trials ISRCTN03013488; ClinicalTrials.gov Identifier: NCT01352247
doi:10.1186/1745-6215-14-292
PMCID: PMC3848560  PMID: 24028414
Medial compartment osteoarthritis; Total knee replacement; Unicompartmental knee replacement; Equipoise; Expertise
21.  Informed consent for upper gastrointestinal endoscopy. 
Gut  1995;37(1):151-153.
Informed consent for upper gastrointestinal endoscopy requires that the patient understands the nature of, and reason for, the proposed procedure, and that he or she is given adequate time to deliberate and ask questions. In a prospective study, 200 outpatients completed questionnaires immediately before, and one day after, endoscopy, which assessed satisfaction with information provided by: (a) the referring doctor, (b) a standard information sheet sent out two to four weeks before endoscopy, and (c) the endoscopist. The first 100 patients were asked to read and sign a standard consent form immediately before the endoscopy. In the second 100 patients, a new endoscopy consent form that was simpler and easier to read than the standard form was sent out with the information sheet. Patients were directed to sign the new consent form before arriving at the unit only if they had no further questions. Overall, the indication for the endoscopy, and how it would be done, were explained clearly by the referring doctor in 79% and 68% of cases, respectively. Of the first 100 patients, only 54% had read the standard consent form in the endoscopy unit before signing it. In contrast, of the second 100 patients, the new form sent with the information sheet was read by 95%, and signed by 88% before coming to the unit. Furthermore, 84% found the new form easier to read and understand than the standard form. In our unit, roughly one quarter of patients referred for endoscopy are not adequately informed about the procedure. In contrast with the standard consent form, a simple endoscopy consent form sent out with the information sheet is preferred by most patients, and safeguards against patients undergoing endoscopy without informed consent.
PMCID: PMC1382789  PMID: 7672668
22.  Maximum recovery after knee replacement – the MARKER study rationale and protocol 
Background
There is little scientific evidence to support the usual practice of providing outpatient rehabilitation to patients undergoing total knee replacement surgery (TKR) immediately after discharge from the orthopaedic ward. It is hypothesised that the lack of clinical benefit is due to the low exercise intensity tolerated at this time, with patients still recovering from the effects of major orthopaedic surgery. The aim of the proposed clinical trial is to investigate the clinical and cost effectiveness of a novel rehabilitation strategy, consisting of an initial home exercise programme followed, approximately six weeks later, by higher intensity outpatient exercise classes.
Methods/Design
In this multicentre randomised controlled trial, 600 patients undergoing primary TKR will be recruited at the orthopaedic pre-admission clinic of 10 large public and private hospitals in Australia. There will be no change to the medical or rehabilitative care usually provided while the participant is admitted to the orthopaedic ward. After TKR, but prior to discharge from the orthopaedic ward, participants will be randomised to either the novel rehabilitation strategy or usual rehabilitative care as provided by the hospital or recommended by the orthopaedic surgeon. Outcomes assessments will be conducted at baseline (pre-admission clinic) and at 6 weeks, 6 months and 12 months following randomisation. The primary outcomes will be self-reported knee pain and physical function. Secondary outcomes include quality of life and objective measures of physical performance. Health economic data (health sector and community service utilisation, loss of productivity) will be recorded prospectively by participants in a patient diary. This patient cohort will also be followed-up annually for five years for knee pain, physical function and the need or actual incidence of further joint replacement surgery.
Discussion
The results of this pragmatic clinical trial can be directly implemented into clinical practice. If beneficial, the novel rehabilitation strategy of utilising outpatient exercise classes during a later rehabilitation phase would provide a feasible and potentially cost-effective intervention to optimise the physical well-being of the large number of people undergoing TKR.
Trial Registration
ACTRN12609000054213
doi:10.1186/1471-2474-10-69
PMCID: PMC2709653  PMID: 19534770
23.  Multimedia Consent for Research in People With Schizophrenia and Normal Subjects: a Randomized Controlled Trial 
Schizophrenia Bulletin  2008;35(4):719-729.
Limitations of printed, text-based, consent forms have long been documented and may be particularly problematic for persons at risk for impaired decision-making capacity, such as those with schizophrenia. We conducted a randomized controlled comparison of the effectiveness of a multimedia vs routine consent procedure (augmented with a 10-minute control video presentation) as a means of enhancing comprehension among 128 middle-aged and older persons with schizophrenia and 60 healthy comparison subjects. The primary outcome measure was manifest decisional capacity (understanding, appreciation, reasoning, and expression of choice) for participation in a (hypothetical) clinical drug trial, as measured with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and the University of California San Diego (UCSD) Brief Assessment for Capacity to Consent (UBACC). The MacCAT-CR and UBACC were administered by research assistants kept blind to consent condition. Additional assessments included standardized measures of psychopathology and cognitive functioning. Relative to patients in the routine consent condition, schizophrenia patients receiving multimedia consent had significantly better scores on the UBACC and on the MacCAT-CR understanding and expression of choice subscales and were significantly more likely to be categorized as being capable to consent than those in the routine consent condition (as categorized with several previously established criteria). Among the healthy subjects, there were few significant effects of consent condition. These findings suggest that multimedia consent procedures may be a valuable consent aid that should be considered for use when enrolling participants at risk for impaired decisional capacity, particularly for complex and/or high-risk research protocols.
doi:10.1093/schbul/sbm148
PMCID: PMC2696362  PMID: 18245061
bioethics; mental competency; informed consent; multimedia learning; cognition disorders; schizophrenia
24.  Regional and systemic prophylaxis with teicoplanin in monolateral and bilateral total knee replacement procedures: study of pharmacokinetics and tissue penetration. 
Antimicrobial Agents and Chemotherapy  1993;37(12):2693-2698.
Twenty-four patients undergoing monolateral or bilateral total knee replacement (TKR) procedures were randomized to receive teicoplanin (T) either systemically or regionally. Subjects scheduled for systemic prophylaxis and undergoing monolateral (six patients) or bilateral (five patients) TKR received a single 800-mg dose of T in 100 ml of saline as a 5-min infusion into a forearm vein 2.5 h before surgery. For regional prophylaxis, patients undergoing monolateral surgery (eight subjects) received 400 mg of T in 100 ml of saline as a 5-min infusion into a foot vein of the leg to be operated on immediately after the tourniquet was inflated. For the five patients scheduled for bilateral operation and regional prophylaxis, the administration of T was also repeated for the second knee operation. The tourniquet, as the standard TKR surgical technique, was inflated to 400 mm Hg (c. 50 kPa) in all 24 patients immediately before the beginning of surgery and kept in place for the duration of the operation. Samples of serum, bone, skin, synovia, and subcutaneous tissue were collected at timed intervals during surgery. They were microbiologically assayed for T by using Bacillus subtilis as the test organism. Overall, the mean T concentrations obtained with regional route prophylaxis were found to be 2 to 10 times higher than those achieved following systemic prophylaxis. Moreover, peak levels in different tissues after regional prophylaxis were significantly higher (P < 0.05). None of the patients experienced adverse effects due to regional or systemic T administration; no prosthetic or wound infections were observed in the follow-up period (from 12 to 26 months).
PMCID: PMC192781  PMID: 8109937
25.  A randomized clinical trial of a peri-operative behavioral intervention to improve physical activity adherence and functional outcomes following total knee replacement 
Background
Total knee replacement (TKR) is a common and effective surgical procedure to relieve advanced knee arthritis that persists despite comprehensive medical treatment. Although TKR has excellent technical outcomes, significant variation in patient-reported functional improvement post-TKR exists. Evidence suggests that consistent post-TKR exercise and physical activity is associated with functional gain, and that this relationship is influenced by emotional health. The increasing use of TKR in the aging US population makes it critical to find strategies that maximize functional outcomes.
Methods/Design
This randomized clinical trial (RCT) will test the efficacy of a theory-based telephone-delivered Patient Self-Management Support intervention that seeks to enhance adherence to independent exercise and activity among post- TKR patients. The intervention consists of 12 sessions, which begin prior to surgery and continue for approximately 9 weeks post-TKR. The intervention condition will be compared to a usual care control condition using a randomized design and a probabilistic sample of men and women. Assessments are conducted at baseline, eight weeks, and six- and twelve- months. The project is being conducted at a large healthcare system in Massachusetts. The study was designed to provide greater than 80% power for detecting a difference of 4 points in physical function (SF36/Physical Component Score) between conditions (standard deviation of 10) at six months with secondary outcomes collected at one year, assuming a loss to follow up rate of no more than 15%.
Discussion
As TKR use expands, it is important to develop methods to identify patients at risk for sub-optimal functional outcome and to effectively intervene with the goal of optimizing functional outcomes. If shown efficacious, this peri-TKR intervention has the potential to change the paradigm for successful post-TKR care. We hypothesize that Patient Self-Management Support to enhance adherence to independent activity and exercise will enhance uniform, optimal improvement in post-TKR function and patient autonomy, the ultimate goals of TKR.
Trial Registration
ClinicalTrials.gov: NCT00566826
doi:10.1186/1471-2474-12-226
PMCID: PMC3205067  PMID: 21981909

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