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author:("wachter, Juul")
1.  Platelet-rich therapy in the treatment of patients with hip fractures: a single centre, parallel group, participant-blinded, randomised controlled trial 
BMJ Open  2013;3(6):e002583.
Objective
To quantify and draw inferences on the clinical effectiveness of platelet-rich therapy in the management of patients with a typical osteoporotic fracture of the hip.
Design
Single centre, parallel group, participant-blinded, randomised controlled trial.
Setting
UK Major Trauma Centre.
Participants
200 of 315 eligible patients aged 65 years and over with any type of intracapsular fracture of the proximal femur. Patients were excluded if their fracture precluded internal fixation.
Interventions
Participants underwent internal fixation of the fracture with cannulated screws and were randomly allocated to receive an injection of platelet-rich plasma into the fracture site or not.
Main outcome measures
Failure of fixation within 12 months, defined as any revision surgery.
Results
Primary outcome data were available for 82 of 101 and 78 of 99 participants allocated to test and control groups, respectively; the remainder died prior to final follow-up. There was an absolute risk reduction of 5.6% (95% CI −10.6% to 21.8%) favouring treatment with platelet-rich therapy (χ2 test, p=0.569). An adjusted effect estimate from a logistic regression model was similar (OR=0.71, 95% CI 0.36 to 1.40, z test; p=0.325). There were no significant differences in any of the secondary outcome measures excepting length of stay favouring treatment with platelet-rich therapy (median difference 8 days, Mann-Whitney U test; p=0.03). The number and distribution of adverse events were similar. Estimated cumulative incidence functions for the competing events of death and revision demonstrated no evidence of a significant treatment effect (HR 0.895, 95% CI 0.533 to 1.504; p=0.680 in favour of platelet-rich therapy).
Conclusions
No evidence of a difference in the risk of revision surgery within 1 year in participants treated with platelet-rich therapy compared with those not treated. However, we cannot definitively exclude a clinically meaningful difference.
Trial registration
Current Controlled Trials, ISRCTN49197425, http://www.controlled-trials.com/ISRCTN49197425
doi:10.1136/bmjopen-2013-002583
PMCID: PMC3696873  PMID: 23801709
Rheumatology
2.  Cost-effectiveness of total hip arthroplasty versus resurfacing arthroplasty: economic evaluation alongside a clinical trial 
BMJ Open  2012;2(5):e001162.
Objective
To report on the relative cost-effectiveness of total hip arthroplasty and resurfacing arthroplasty (replacement of articular surface of femoral head only) in patients with severe arthritis suitable for hip joint resurfacing arthroplasty.
Design
Cost-effectiveness analysis on an intention-to-treat basis of a single-centre, single-blind randomised controlled trial of 126 adult patients within 12 months of treatment. Missing data were imputed using multiple imputations with differences in baseline quality of life and gender adjusted using regression techniques.
Setting
A large teaching hospital trust in the UK.
Participants
A total of 126 adult patients with severe arthritis of the hip joint suitable for a resurfacing arthroplasty of the hip.
Results
Data were received for 126 patients, 4 of whom did not provide any resource use data. For the remainder, data were imputed for costs or quality of life in at least one time point (baseline, 3, 6 months and 1 year) for 18 patients. Patients in the resurfacing arm had higher quality of life at 12 months (0.795 vs 0.727) and received 0.032 more QALYs within the first 12 months postoperation. At an additional cost of £564, resurfacing arthroplasty offers benefits at £17 451 per QALY within the first 12 months of treatment. When covariates are considered, the health economic case is stronger in men than in women.
Conclusions
Resurfacing arthroplasty appears to offer very short-term efficiency benefits over total hip arthroplasty within a selected patient group. The short-term follow-up in this trial should be noted, particularly in light of the concerns raised regarding adverse reactions to metal debris from metal-on-metal bearing surfaces in the longer term. Longer-term follow-up of resurfacing arthroplasty patients and decision analytic modelling is also advised.
Trial registration
Current controlled Trials ISRCTN33354155. UKCRN 4093.
doi:10.1136/bmjopen-2012-001162
PMCID: PMC3488749  PMID: 23065450
Orthopaedic & trauma surgery < SURGERY
3.  An evaluation of the quality of statistical design and analysis of published medical research: results from a systematic survey of general orthopaedic journals 
Background
The application of statistics in reported research in trauma and orthopaedic surgery has become ever more important and complex. Despite the extensive use of statistical analysis, it is still a subject which is often not conceptually well understood, resulting in clear methodological flaws and inadequate reporting in many papers.
Methods
A detailed statistical survey sampled 100 representative orthopaedic papers using a validated questionnaire that assessed the quality of the trial design and statistical analysis methods.
Results
The survey found evidence of failings in study design, statistical methodology and presentation of the results. Overall, in 17% (95% confidence interval; 10–26%) of the studies investigated the conclusions were not clearly justified by the results, in 39% (30–49%) of studies a different analysis should have been undertaken and in 17% (10–26%) a different analysis could have made a difference to the overall conclusions.
Conclusion
It is only by an improved dialogue between statistician, clinician, reviewer and journal editor that the failings in design methodology and analysis highlighted by this survey can be addressed.
doi:10.1186/1471-2288-12-60
PMCID: PMC3476984  PMID: 22533688
4.  The Achilles tendon total rupture score: a study of responsiveness, internal consistency and convergent validity on patients with acute Achilles tendon ruptures 
Background
The Achilles tendon Total Rupture Score was developed by a research group in 2007 in response to the need for a patient reported outcome measure for this patient population. Beyond this original development paper, no further validation studies have been published.
Consequently the purpose of this study was to evaluate internal consistency, convergent validity and responsiveness of this newly developed patient reported outcome measure within patients who have sustained an isolated acute Achilles tendon rupture.
Methods
Sixty-four eligible patients with an acute rupture of their Achilles tendon completed the Achilles tendon Total Rupture Score alongside two further patient reported outcome measures (Disability Rating Index and EQ 5D). These were completed at baseline, six weeks, three months, six months and nine months post injury. The Achilles tendon Total Rupture Score was evaluated for internal consistency, using Cronbach's alpha, convergent validity, through correlation analysis and responsiveness, by analysing floor and ceiling effects and calculating its relative efficiency in comparison to the Disability Rating Index and EQ 5D scores.
Results
The Achilles tendon Total Rupture Score demonstrated high internal consistency (Cronbachs alpha > 0.8) and correlated significantly (p < 0.001) with the Disability Rating Index at five time points (pre-injury, six weeks, three, six and nine months) with correlation coefficients between -0.5 and -0.9. However, the confidence intervals were wide. Furthermore, the ability of the new score to detect clinically important changes over time (responsiveness) was shown to be greater than the Disability Rating Index and EQ 5D.
Conclusions
A universally accepted outcome measure is imperative to allow comparisons to be made across practice. This is the first study to evaluate aspects of validity of this newly developed outcome measure, outside of the developing centre. The ATRS demonstrated high internal consistency and responsiveness, with limited convergent validity. This research provides further support for the use of this outcome measure, however further research is required to advocate its universal use in patients with acute Achilles tendon ruptures. Such areas include inter-rater reliability and research to determine the minimally clinically important difference between scores.
All authors have read and concur with the content of this manuscript. The material presented has not been and will not be submitted for publication elsewhere, except as an abstract. All authors have made substantial contributions to all of the following: (1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content and (3) final approval of the submitted version. This research has been funded by Arthritis Research UK, no conflicts of interests have been declared by the authors.
Kind Regards
Rebecca Kearney (corresponding author)
Research Physiotherapist
doi:10.1186/1477-7525-10-24
PMCID: PMC3305449  PMID: 22376047
Achilles tendon; Rupture; Questionnaires; Treatment Outcome
5.  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
6.  UK DRAFFT - A randomised controlled trial of percutaneous fixation with kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius 
Background
Fractures of the distal radius are extremely common injuries in adults. However, the optimal management remains controversial. In general, fractures of the distal radius are treated non-operatively if the bone fragments can be held in anatomical alignment by a plaster cast or orthotic. However, if this is not possible, then operative fixation is required. There are several operative options but the two most common in the UK, are Kirschner-wire fixation (K-wires) and volar plate fixation using fixed-angle screws (locking-plates). The primary aim of this trial is to determine if there is a difference in the Patient-Reported Wrist Evaluation one year following K-wire fixation versus locking-plate fixation for adult patients with a dorsally-displaced fracture of the distal radius.
Methods/design
All adult patients with an acute, dorsally-displaced fracture of the distal radius, requiring operative fixation are potentially eligible to take part in this study. A total of 390 consenting patients will be randomly allocated to either K-wire fixation or locking-plate fixation. The surgery will be performed in trauma units across the UK using the preferred technique of the treating surgeon. Data regarding wrist function, quality of life, complications and costs will be collected at six weeks and three, six and twelve months following the injury. The primary outcome measure will be wrist function with a parallel economic analysis.
Discussion
This pragmatic, multi-centre trial is due to deliver results in December 2013.
Trial registration
Current Controlled Trials ISRCTN31379280
UKCRN portfolio ID 8956
doi:10.1186/1471-2474-12-201
PMCID: PMC3182964  PMID: 21914196
7.  The comprehensive cohort model in a pilot trial in orthopaedic trauma 
Background
The primary aim of this study was to provide an estimate of effect size for the functional outcome of operative versus non-operative treatment for patients with an acute rupture of the Achilles tendon using accelerated rehabilitation for both groups of patients. The secondary aim was to assess the use of a comprehensive cohort research design (i.e. a parallel patient-preference group alongside a randomised group) in improving the accuracy of this estimate within an orthopaedic trauma setting.
Methods
Pragmatic randomised controlled trial and comprehensive cohort study within a level 1 trauma centre. Twenty randomised participants (10 operative and 10 non-operative) and 29 preference participants (3 operative and 26 non-operative). The ge range was 22-72 years and 37 of the 52 patients were men. All participants had an acute rupture of their Achilles tendon and no other injuries. All of the patients in the operative group had a simple end-to-end repair of the tendon with no augmentation. Both groups then followed the same eight-week immediate weight-bearing rehabilitation programme using an off-the-shelf orthotic. The disability rating index (DRI; primary outcome), EQ-5D, Achilles Total Rupture Score and complications were assessed ed at two weeks, six weeks, three months, six months and nine months after initial injury.
Results
At nine months, there was no significant difference in DRI between patients randomised to operative or non-operative management. There was no difference in DRI between the randomised group and the parallel patient preference group. The use of a comprehensive cohort of patients did not provide useful additional information as to the treatment effect size because the majority of patients chose non-operative management.
Conclusions
Recruitment to clinical trials that compare operative and non-operative interventions is notoriously difficult; especially within the trauma setting. Including a parallel patient preference group to create a comprehensive cohort of patients has been suggested as a way of increasing the power of such trials. In our study, the comprehensive cohort model doubled the number of patients involved in the study. However, a strong preference for non-operative treatment meant that the increased number of patients did not significantly increase the ability of the trial to detect a difference between the two interventions.
Trial registration
ISRCTN: ISRCTN29053307
doi:10.1186/1471-2288-11-39
PMCID: PMC3083383  PMID: 21466700
8.  Warwick Hip Trauma Study: a randomised clinical trial comparing interventions to improve outcomes in internally fixed intracapsular fractures of the proximal femur. Protocol for The WHiT Study 
Background
Controversy exists regarding the optimal treatment for patients with displaced intracapsular fractures of the proximal femur. The recognised treatment alternatives are arthroplasty and internal fixation. The principal criticism of internal fixation is the high rate of non-union; up to 30% of patients will have a failure of the fixation leading to revision surgery. We believe that improved fracture healing may lead to a decreased rate of failure of fixation. We therefore propose to investigate strategies to both accelerate fracture healing and improve fixation that may significantly improve outcomes after internal fixation of intracapsular femoral fractures. We aim to test the clinical effectiveness of the osteoinductive agent platelet rich plasma and conduct a pilot study of a novel fixed-angle fixation system.
Design
We have planned a three arm, single centre, standard-of-care controlled, double blinded, pragmatic, randomised clinical trial. The trial will include a standard two-way comparison between platelet-rich plasma and standard-of-care fixation versus standard-of-care fixation alone. In addition there will be a subsidiary pilot arm testing a fixed-angle screw and plate fixation system.
Trial Registration
Current Controlled Trials ISRCTN49197425
doi:10.1186/1471-2474-11-184
PMCID: PMC2928173  PMID: 20716348
9.  A randomised controlled trial of total hip arthroplasty versus resurfacing arthroplasty in the treatment of young patients with arthritis of the hip joint 
Background
Hip replacement (arthroplasty) surgery is a highly successful treatment for patients with severe symptomatic arthritis of the hip joint. For older patients, several designs of Total Hip Arthroplasty have shown excellent results in terms of both function and value for money. However, in younger more active patients, there is approximately a 50% failure rate at 25 years for traditional implants. Hip resurfacing is a relatively new arthroplasty technique. In a recent review of the literature on resurfacing arthroplasty it was concluded that the short-term functional results appear promising but some potential early disadvantages were identified, including the risk of femoral neck fracture and collapse of the head of the femur. The aim of the current study is to assess whether there is a difference in functional hip scores at one year post-operation between Total Hip Arthroplasty and Resurfacing Arthroplasty. Secondary aims include assessment of complication rates for both procedures as well cost effectiveness.
Methods/design
All patients medically fit for surgery and deemed suitable for a resurfacing arthroplasty are eligible to take part in this study. A randomisation sequence will be produced and administered independently. After consenting, all patients will be clinically reviewed and hip function, quality of life and physical activity level will be assessed through questionnaires. The allocated surgery will then be performed with the preferred technique of the surgeon. Six weeks post-operation hip function will be assessed and complications recorded. Three, six and 12 months post-operation hip function, quality of life and physical activity level will be assessed. Additional information about patients' out-of-pocket expenses will also be collected.
Trial registration
Current Controlled Trials ISRCTN33354155
UKCLRN portfolio ID 4093
doi:10.1186/1471-2474-11-8
PMCID: PMC2826290  PMID: 20074324
10.  Total hip arthroplasty versus resurfacing arthroplasty in the treatment of patients with arthritis of the hip joint: single centre, parallel group, assessor blinded, randomised controlled trial 
Objectives To compare the clinical and cost effectiveness of total hip arthroplasty with resurfacing arthroplasty in patients with severe arthritis of the hip.
Design Single centre, two arm, parallel group, assessor blinded, randomised controlled trial with 1:1 treatment allocation.
Setting One large teaching hospital in the United Kingdom.
Participants 126 patients older than 18 years with severe arthritis of the hip joint, suitable for resurfacing arthroplasty of the hip. Patients were excluded if they were considered to be unable to adhere to trial procedures or complete questionnaires.
Interventions Total hip arthroplasty (replacement of entire femoral head and neck); hip resurfacing arthroplasty (replacement of the articular surface of femoral head only, femoral neck remains intact). Both procedures replaced the articular surface of the acetabulum.
Main outcome measures Hip function at 12 months after surgery, assessed using the Oxford hip score and Harris hip score. Secondary outcomes were quality of life, disability rating, physical activity level, complications, and cost effectiveness.
Results 60 patients were randomly assigned to hip resurfacing arthroplasty and 66 to total hip arthroplasty. Intention to treat analysis showed no evidence for a difference in hip function between treatment groups at 12 months (t test, P=0.242 and P=0.070 for Oxford hip score and Harris hip score, respectively); 95% of follow-up data was available for analysis. Mean Oxford hip score was 40.4 (95% confidence interval 37.9 to 42.9) in the resurfacing group and 38.2 (35.3 to 41.0) in the total arthroplasty group (estimated treatment effect size 2.23 (−1.52 to 5.98)). Mean Harris hip score was 88.4 (84.4 to 92.4) in the resurfacing group and 82.3 (77.2 to 87.5) in the total arthroplasty group (6.04 (−0.51 to 12.58)). Although we saw no evidence of a difference, we cannot definitively exclude clinically meaningful differences in hip function in the short term. Overall complication rates did not differ between treatment groups (P=0.291). However, we saw more wound complications in the total arthroplasty group (P=0.056) and more thromboembolic events in the resurfacing group (P=0.049).
Conclusions No evidence of a difference in hip function was seen in patients with severe arthritis of the hip, one year after receiving a total hip arthroplasty versus resurfacing arthroplasty. The long term effects of these interventions remain uncertain.
Trial registration Current Controlled Trials ISRCTN33354155, UKCRN 4093.
doi:10.1136/bmj.e2147
PMCID: PMC3330050  PMID: 22517930

Results 1-10 (10)