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1.  The challenge of recruiting patients into a placebo-controlled surgical trial 
Trials  2014;15:167.
Background
Randomized placebo-controlled trials represent the gold standard in evaluating healthcare interventions but are rarely performed within orthopedics. Ethical concerns or well-known challenges in recruiting patients for surgical trials in general have been expressed and adding a placebo component only adds to this complexity. The purpose of this study was to report the challenges of recruiting patients into an orthopedic placebo-controlled surgical trial, to determine the number of patients needed to be screened and allocated in order to include one participant into the trial, and to identify reasons associated with participation in a placebo-controlled randomized surgical trial.
Methods
Data were extracted from an ongoing placebo-controlled randomized controlled trial (RCT) on meniscectomy versus placebo surgery. We calculated the number of patients needed to be screened in order to include the required number of participants into the RCT. Participating patients were asked about their rationale for joining the study and which type of information was most useful for deciding upon participation.
Results
A total of 476 patients entered the screening group, of which 190 patients fulfilled the inclusion and exclusion criteria. 102 patients declined to participate in the study due to various reasons and 46 were later excluded (no meniscus lesion on the magnetic resonance imaging scan or withdrawn consent). A total of 40 patients were finally included in the RCT. To include one patient into the RCT, 11.9 individuals needed to be screened. A total of 69% of participating patients considered the oral information to be the most important and the most common reason for participating was the contribution to research (90%).
Conclusions
Patients are willing to participate in an orthopedic placebo-controlled surgical trial. Oral information given by the surgeon to the patient and the contribution to research are important aspects to enhance patient recruitment.
Trial registration
ClinicalTrials.gov NCT01264991, registered 21 December 2010.
doi:10.1186/1745-6215-15-167
PMCID: PMC4030043  PMID: 24884948
Feasibility; Placebo; Surgery; Recruitment; Trial
2.  Clinical Outcomes Assessment in Clinical Trials to Assess Treatment of Femoroacetabular Impingement: Use of Patient-reported Outcome Measures 
Patient-reported outcome measures are an important component of outcomes assessment in clinical trials to assess the treatment of femoroacetabular impingement (FAI). This review of disease-specific measures and instruments used to assess the generic quality of life and physical activity levels of patients with FAI found no conclusive evidence to support a single disease-specific questionnaire. Using a systematic review of study methodology, the Copenhagen Hip and Groin Outcome Score and the 33-item International Hip Outcome Tool scored the best. Nevertheless, both of these instruments were developed recently and have not been established in the literature. Although currently used generic and activity-level measures have limitations, as well, they should be considered, depending on the specific goals of the study. Additional research is needed to assess the properties of these measures fully when used to evaluate patients with FAI.
doi:10.5435/JAAOS-21-07-S39
PMCID: PMC3971004  PMID: 23818190
3.  Minimal clinically important improvement (MCII) and patient-acceptable symptom state (PASS) in total hip arthroplasty (THA) patients 1 year postoperatively 
Acta Orthopaedica  2014;85(1):39-48.
Background and purpose
The increased use of patient-reported outcomes (PROs) in orthopedics requires data on estimated minimal clinically important improvements (MCIIs) and patient-acceptable symptom states (PASSs). We wanted to find cut-points corresponding to minimal clinically important PRO change score and the acceptable postoperative PRO score, by estimating MCII and PASS 1 year after total hip arthroplasty (THA) for the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and the EQ-5D.
Patients and methods
THA patients from 16 different departments received 2 PROs and additional questions preoperatively and 1 year postoperatively. The PROs included were the HOOS subscales pain (HOOS Pain), physical function short form (HOOS-PS), and hip-related quality of life (HOOS QoL), and the EQ-5D. MCII and PASS were estimated using multiple anchor-based approaches.
Results
Of 1,837 patients available, 1,335 answered the preoperative PROs, and 1,288 of them answered the 1-year follow-up. The MCIIs and PASSs were estimated to be: 24 and 91 (HOOS Pain), 23 and 88 (HOOS-PS), 17 and 83 (HOOS QoL), 0.31 and 0.92 (EQ-5D Index), and 23 and 85 (EQ-VAS), respectively. MCIIs corresponded to a 38–55% improvement from mean baseline PRO score and PASSs corresponded to absolute follow-up scores of 57–91% of the maximum score in THA patients 1 year after surgery.
Interpretation
This study improves the interpretability of PRO scores. The different estimation approaches presented may serve as a guide for future MCII and PASS estimations in other contexts. The cutoff points may serve as reference values in registry settings.
doi:10.3109/17453674.2013.867782
PMCID: PMC3940990  PMID: 24286564
4.  High prevalence of daily and multi-site pain – a cross-sectional population-based study among 3000 Danish adolescents 
BMC Pediatrics  2013;13:191.
Background
Daily pain and multi-site pain are both associated with reduction in work ability and health-related quality of life (HRQoL) among adults. However, no population-based studies have yet investigated the prevalence of daily and multi-site pain among adolescents and how these are associated with respondent characteristics. The purpose of this study was to investigate the prevalence of self-reported daily and multi-site pain among adolescents aged 12–19 years and associations of almost daily pain and multi-site pain with respondent characteristics (sex, age, body mass index, HRQoL and sports participation).
Methods
A population-based cross-sectional study was conducted among 4,007 adolescents aged 12–19 years in Denmark. Adolescents answered an online questionnaire during physical education lessons. The questionnaire contained a mannequin divided into 12 regions on which the respondents indicated their current pain sites and pain frequency (rarely, monthly, weekly, more than once per week, almost daily pain), characteristics, sports participation and HRQoL measured by the EuroQoL 5D. Multivariate regression was used to calculate the odds ratio for the association between almost daily pain, multi-site pain and respondent characteristics.
Results
The response rate was 73.7%. A total of 2,953 adolescents (62% females) answered the questionnaire. 33.3% reported multi-site pain (pain in >1 region) while 19.8% reported almost daily pain. 61% reported current pain in at least one region with knee and back pain being the most common sites. Female sex (OR: 1.35-1.44) and a high level of sports participation (OR: 1.51-2.09) were associated with increased odds of having almost daily pain and multi-site pain. Better EQ-5D score was associated with decreased odds of having almost daily pain or multi-site pain (OR: 0.92-0.94).
Conclusion
In this population-based cohort of school-attending Danish adolescents, nearly two out of three reported current pain and, on average, one out of three reported pain in more than one body region. Female sex, and high level of sports participation were associated with increased odds of having almost daily pain and multi-site pain. The study highlights an important health issue that calls for investigations to improve our understanding of adolescent pain and our capacity to prevent and treat this condition.
doi:10.1186/1471-2431-13-191
PMCID: PMC3840664  PMID: 24252440
Adolescents; Pain; Cohort study; Paediatrics; Pain
5.  Effects of neuromuscular training (NEMEX-TJR) on patient-reported outcomes and physical function in severe primary hip or knee osteoarthritis: a controlled before-and-after study 
Background
The benefits of exercise in mild and moderate knee or hip osteoarthritis (OA) are apparent, but the evidence in severe OA is less clear. We recently reported that neuromuscular training was well tolerated and feasible in patients with severe primary hip or knee OA. The aims of this controlled before-and-after study were to compare baseline status to an age-matched population-based reference group and to examine the effects of neuromuscular training on patient-reported outcomes and physical function in patients with severe primary OA of the hip or knee.
Methods
87 patients (60–77 years) with severe primary OA of the hip (n = 38, 55% women) or knee (n = 49, 59% women) awaiting total joint replacement (TJR) had supervised, neuromuscular training (NEMEX-TJR) in groups with individualized level and progression of training. A reference group (n = 43, 53% women) was included for comparison with patients’ data. Assessments included self-reported outcomes (HOOS/KOOS) and measures of physical function (chair stands, number of knee bends/30 sec, knee extensor strength, 20-meter walk test) at baseline and at follow-up before TJR. Analysis of covariance (ANCOVA) was used for comparing patients and references and elucidating influence of demographic factors on change. The paired t-test was used for comparisons within groups.
Results
At baseline, patients reported worse scores than the references in all HOOS/KOOS subscales (hip 27–47%, knee 14–52%, of reference scores, respectively) and had functional limitations (hip 72–85%, knee 42–85%, of references scores, respectively). NEMEX-TJR (mean 12 weeks (SD 5.6) of training) improved self-reported outcomes (hip 9–29%, knee 7–20%) and physical function (hip 3–18%, knee 5–19%) (p < 0.005). Between 42% and 62% of hip OA patients, and 39% and 61% of knee OA patients, displayed a clinically meaningful improvement (≥15%) in HOOS/KOOS subscales by training. The improvement in HOOS/KOOS subscale ADL was greater for patients with knee OA than hip OA, while the improvement in subscale Sport/Rec was greater for patients with hip OA than knee OA.
Conclusions
Both self-reported outcomes and physical function were clearly worse compared with the reference group. Neuromuscular training with an individualized approach and gradual progression showed promise for improving patient-reported outcomes and physical function even in older patients with severe primary OA of the hip or knee.
doi:10.1186/1471-2474-14-232
PMCID: PMC3750589  PMID: 23924144
Osteoarthritis; Arthroplasty; Exercise therapy; Patient-reported outcomes; Performance-based measures
6.  Care-seeking behaviour of adolescents with knee pain: a population-based study among 504 adolescents 
Background
Knee pain is common during adolescence. Adolescents and their parents may think that knee pain is benign and self-limiting and therefore avoid seeking medical care. However, long-term prognosis of knee pain is not favourable and treatment seems to offer greater reductions in pain compared to a “wait-and-see” approach. The purpose of this study was to describe the determinants of care-seeking behaviour among adolescents with current knee pain and investigate what types of treatment are initiated.
Methods
An online questionnaire was forwarded to 2,846 adolescents aged 15–19 in four upper secondary schools. The questionnaire contained questions on age, gender, height, weight, currently painful body regions, frequency of knee pain, health-related quality of life measured by the EuroQol 5-dimensions, sports participation and if they had sought medical care. Adolescents who reported current knee pain at least monthly or more frequently were telephoned. The adolescents were asked about pain duration, onset of knee pain (traumatic or insidious) and if they were currently being treated for their knee pain.
Results
504 adolescents currently reported at least monthly knee pain. 59% of these had sought medical care and 18% were currently under medical treatment . A longer pain duration and higher pain severity increased the odds of seeking medical care. Females with traumatic onset of knee pain were more likely to have sought medical care than females with insidious onset of knee pain. Females with traumatic onset of knee pain and increased pain severity were more likely to be undergoing medical treatment. The most frequently reported treatments were the combination of exercises and orthotics (68% of those undergoing medical treatment).
Conclusion
Females with insidious onset of knee pain do not seek medical care as often as those with traumatic onset and adolescents of both genders with insidious onset are less likely to be under medical treatment. These findings are important as knee pain with insidious onset has similar consequences as knee pain with traumatic onset regarding pain severity, pain duration and reductions in health-related quality of life.
doi:10.1186/1471-2474-14-225
PMCID: PMC3729825  PMID: 23899043
Adolescents; Knee pain; Care-seeking; Treatment
7.  The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis 
The Knee injury and Osteoarthritis Outcome Score (KOOS) was developed as an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The KOOS has been validated for several orthopaedic interventions such as anterior cruciate ligament reconstruction, meniscectomy and total knee replacement. In addition the instrument has been used to evaluate physical therapy, nutritional supplementation and glucosamine supplementation. The effect size is generally largest for the subscale QOL followed by the subscale Pain. The KOOS is a valid, reliable and responsive self-administered instrument that can be used for short-term and long-term follow-up of several types of knee injury including osteoarthritis. The measure is relatively new and further use of the instrument will add knowledge and suggest areas that need to be further explored and improved.
doi:10.1186/1477-7525-1-64
PMCID: PMC280702  PMID: 14613558
8.  Cross-cultural translation and measurement properties of the Polish version of the Knee injury and Osteoarthritis Outcome Score (KOOS) following anterior cruciate ligament reconstruction 
Background
Knee Injury and Osteoarthritis Outcome Score (KOOS) is available in over 30 languages and a commonly used Patient-Reported Outcome (PRO) for assessment of treatment effects following knee surgery. The aim of the study was to report the linguistic translational process and evaluate the psychometric properties of the Polish version of the KOOS questionnaire.
Methods
We translated and culturally adapted the KOOS according to current guidelines for use in Poland. Patients who had undergone anterior cruciate ligament reconstruction (ACLR) completed the KOOS and Short Form 36 Health Survey (SF-36). We evaluated floor/ceiling effects, reliability (using Cronbach’s alpha, intraclass correlation coefficients (ICC) and measurement error), convergent and divergent construct validity (using four a priori stated hypotheses) and responsiveness (using data obtained prior to and one year after ACLR and described by both effect size (ES) and standardized response mean (SRM)).
Results
The clinical study population consisted of 72 subjects (mean age 29.8, 28% women). We did not observe floor effects in any KOOS subscales neither pre- nor postoperatively. As expected, ceiling effects were found postoperatively for the subscales Pain and ADL in this cohort assessed on average 1.3 year after surgery as more than 15% reported no pain or limitations in daily activities. The Cronbach’s alpha was above 0.9 for all subscales indicating excellent internal consistency. The test-retest reliability of all KOOS subscales at one-year postoperatively was excellent with ICCs exceeding 0.86 for all subscales. The minimal detectable change on group level ranged from 1.3 to 2.4, and on an individual level from 10.9 to 20.2. Responsiveness was demonstrated since the expected pattern of effect sizes between subscales following ACLR was found.
Conclusions
We found the Polish version of the KOOS to be a valid and reliable instrument for use in patient groups having ACLR. We caution against monitoring individual patients since the smallest change considered clinically relevant cannot reliably be detected.
doi:10.1186/1477-7525-11-107
PMCID: PMC3695799  PMID: 23803000
Knee injury and Osteoarthritis Outcome Score; Patient-reported outcome; Validation study; Psychometrics; Anterior cruciate ligament; Orthopedic surgery
9.  Effect of pre-operative neuromuscular training on functional outcome after total knee replacement: a randomized-controlled trial 
Background
Total Knee Replacement (TKR) is the standard treatment for patients with severe knee osteoarthritis (OA). Significant improvement in pain and function are seen after TKR and approximately 80% of patients are very satisfied with the outcome. Functional status prior to TKR is a major predictor of outcome after the intervention. Thus, improving functional status prior to surgery through exercise may improve after surgery outcome. However, results from several previous trials testing the concept have been inconclusive after surgery.
Methods/design
In a randomized controlled trial (RCT) we will test the effect of a pre-operative neuromuscular trainingprogram versus an attention control program on lower extremity function – before and after surgery. We will enroll 80 participants, aged between 55–90 years, who are scheduled for TKR. In this single-blinded RCT, the intervention group will receive a minimum of 8 and a maximum of 24 training sessions plus 3 educational sessions of the knee school. The control group will receive the 3 educational sessions only. Assessments are performed immediately before and after the intervention (before surgery), at 6 weeks, 3 months and 12 months (after surgery).
The primary outcome will include the Chair Stand Test as a measure of leg strength and reaction time. Secondary outcomes are knee function and pain assessed with the self-reported Knee Injury and Osteoarthritis Outcome Score (KOOS). All measurements will be carried out by a specially trained physical therapist, blinded to group allocation.
Discussion
To our knowledge this is the first single-blinded RCT to test the effect of pre-operative neuromuscular training plus knee school against knee school alone – on knee function and pain, assessed immediately after the interventions prior to surgery and repeatedly after surgery.
Trial registration
Clinical Trials NCT00913575
doi:10.1186/1471-2474-14-157
PMCID: PMC3651334  PMID: 23641782
10.  Arthroscopic partial meniscectomy in middle-aged patients with mild or no knee osteoarthritis: a protocol for a double-blind, randomized sham-controlled multi-centre trial 
Background
Arthroscopic partial meniscectomy has been shown to be of no benefit to patients with concomitant knee osteoarthritis, but the optimal treatment of a degenerative meniscus tear in patients with mild or no knee osteoarthritis is unknown. This article describes the rationale and methodology of a randomized sham-controlled trial to assess the benefit of arthroscopic partial meniscectomy of a medial meniscus tear in patients with mild or no knee osteoarthritis. The objective of the study is to test whether the benefit from arthroscopic partial meniscectomy in patients with knee pain, medial meniscus lesion and mild/no knee osteoarthritis, is greater after arthroscopic partial meniscectomy than following sham surgery.
Methods
We will conduct a randomized controlled trial of treatment for degenerative meniscus tears in middle-aged patients (aged 35–55 years) with an MRI-verified medial meniscus lesion and mild or no knee radiographic osteoarthritis (grade 0–2 on the Kellgren & Lawrence scale). Patients will be randomized to receive either conventional arthroscopic partial meniscectomy or a sham surgery procedure. The primary outcome will be the KOOS5 derived from the ‘Knee Injury and Osteoarthritis Outcome Score’ at 2 years follow-up. Secondary outcomes at 2 years will include all five individual subscales of the KOOS, a global perceived effect score, the Short-Form-36 health status score, EQ-5D for economic appraisal and objective tests of muscle strength and physical function. Radiographic knee osteoarthritis will be evaluated at 5 years.
Discussion
Demonstration of no additional benefit from arthroscopic partial meniscectomy on pain and function should lead to a change in clinical care of patients with a degenerative meniscus tear. The results of this study will provide empirical evidence for the potential benefit/harm of arthroscopic partial meniscectomy compared to a masked sham-therapeutics intervention.
Trial registration
NCT01264991
doi:10.1186/1471-2474-14-71
PMCID: PMC3599063  PMID: 23442554
11.  The effect of education and supervised exercise vs. education alone on the time to total hip replacement in patients with severe hip osteoarthritis. A randomized clinical trial protocol 
Background
The age- and gender-specific incidence of total hip replacement surgery has increased over the last two decades in all age groups. Recent studies indicate that non-surgical interventions are effective in reducing pain and disability, even at later stages of the disease when joint replacement is considered. We hypothesize that the time to hip replacement can be postponed in patients with severe hip osteoarthritis following participation in a patient education and supervised exercise program when compared to patients receiving patient education alone.
Methods/design
A prospective, blinded, parallel-group multi-center trial (2 sites), with balanced randomization [1:1]. Patients with hip osteoarthritis and an indication for hip replacement surgery, aged 40 years and above, will be consecutively recruited and randomized into two treatment groups. The active treatment group will receive 3 months of supervised exercise consisting of 12 sessions of individualized, goal-based neuromuscular training, and 12 sessions of intensive resistance training plus patient education (3 sessions). The control group will receive only patient education (3 sessions). The primary end-point for assessing the effectiveness of the intervention is 12 months after baseline. However, follow-ups will also be performed once a year for at least 5 years. The primary outcome measure is the time to hip replacement surgery measured on a Kaplain-Meier survival curve from time of inclusion. Secondary outcome measures are the five subscales of the Hip disability and Osteoarthritis Outcome Score, physical activity level (UCLA activity score), and patient’s global perceived effect. Other measures include pain after exercise, joint-specific adverse events, exercise adherence, general health status (EQ-5D-5L), mechanical muscle strength and performance in physical tests. A cost-effectiveness analysis will also be performed.
Discussion
To our knowledge, this is the first randomized clinical trial comparing a patient education plus supervised exercise program to patient education alone in hip osteoarthritis patients with an indication for surgery on the time to total hip replacement.
Trial registration
NCT01697241
doi:10.1186/1471-2474-14-21
PMCID: PMC3561107  PMID: 23311889
Exercise therapy; Education; Osteoarthritis; Hip; Hip replacement
12.  Development of the Knee Injury and Osteoarthritis Outcome Score for Children (KOOS-Child) 
Acta Orthopaedica  2012;83(6):666-673.
Background and purpose
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is distinguished from other knee-specific measures by the inclusion of separate scales for evaluation of activities of daily living, sports and recreation function, and knee-related quality of life, with presentation of separate subscale scores as a profile. However, its applicability in children has not been established. In this study, we examined how well the KOOS could be understood in a cohort of children with knee injury, with a view to preparing a pediatric version (KOOS-Child).
Material and methods
A trained researcher conducted cognitive interviews with 34 Swedish children who had symptomatic knee injuries (either primary or repeated). They were 10–16 years of age, and were selected to allow for equal group representation of age and sex. All the interviews were recorded. 4 researchers analyzed the data and modified the original KOOS questionnaire.
Results
Many children (n =14) had difficulty in tracking items based on the time frame and an equivalent number of children had trouble in understanding several terms. Mapping errors resulted from misinterpretation of items and from design issues related to the item such as double-barreled format. Most children understood how to use the 5-point Likert response scale. Many children found the instructions confusing from both a lexical and a formatting point of view. Overall, most children found that several items were irrelevant.
Interpretation
The original KOOS is not well understood by children. Modifications related to comprehension, mapping of responses, and jargon in the KOOS were made based on qualitative feedback from the children.
doi:10.3109/17453674.2012.747921
PMCID: PMC3555443  PMID: 23140110
13.  The effects of neuromuscular exercise on medial knee joint load post-arthroscopic partial medial meniscectomy: ‘SCOPEX’ a randomised control trial protocol 
Background
Meniscectomy is a risk factor for knee osteoarthritis, with increased medial joint loading a likely contributor to the development and progression of knee osteoarthritis in this group. Therefore, post-surgical rehabilitation or interventions that reduce medial knee joint loading have the potential to reduce the risk of developing or progressing osteoarthritis. The primary purpose of this randomised, assessor-blind controlled trial is to determine the effects of a home-based, physiotherapist-supervised neuromuscular exercise program on medial knee joint load during functional tasks in people who have recently undergone a partial medial meniscectomy.
Methods/design
62 people aged 30–50 years who have undergone an arthroscopic partial medial meniscectomy within the previous 3 to 12 months will be recruited and randomly assigned to a neuromuscular exercise or control group using concealed allocation. The neuromuscular exercise group will attend 8 supervised exercise sessions with a physiotherapist and will perform 6 exercises at home, at least 3 times per week for 12 weeks. The control group will not receive the neuromuscular training program. Blinded assessment will be performed at baseline and immediately following the 12-week intervention. The primary outcomes are change in the peak external knee adduction moment measured by 3-dimensional analysis during normal paced walking and one-leg rise. Secondary outcomes include the change in peak external knee adduction moment during fast pace walking and one-leg hop and change in the knee adduction moment impulse during walking, one-leg rise and one-leg hop, knee and hip muscle strength, electromyographic muscle activation patterns, objective measures of physical function, as well as self-reported measures of physical function and symptoms and additional biomechanical parameters.
Discussion
The findings from this trial will provide evidence regarding the effect of a home-based, physiotherapist-supervised neuromuscular exercise program on medial knee joint load during various tasks in people with a partial medial meniscectomy. If shown to reduce the knee adduction moment, neuromuscular exercise has the potential to prevent the onset of osteoarthritis or slow its progression in those with early disease.
Trial Registration
Australian New Zealand Clinical Trials Registry reference: ACTRN12612000542897
doi:10.1186/1471-2474-13-233
PMCID: PMC3529104  PMID: 23181415
14.  Efficacy of multimodal, systematic non-surgical treatment of knee osteoarthritis for patients not eligible for a total knee replacement: a study protocol of a randomised controlled trial 
BMJ Open  2012;2(6):e002168.
Introduction
It is recommended that non-operative treatment of knee osteoarthritis (KOA) should be individually tailored and include multiple treatment modalities. Despite these recommendations, no one has yet investigated the efficacy of combining several non-surgical treatment modalities in a randomised controlled study. The purpose of this randomised controlled study is to examine if an optimised, combined non-surgical treatment programme results in greater improvements in pain, function and quality of life in comparison with usual care in patients with KOA who are not eligible for total knee arthroplasty (TKA).
Methods and analysis
This study will include 100 consecutive patients from the North Denmark Region not eligible for TKA with radiographic KOA (K-L grade ≥1) and mean pain during the previous week of ≤60 mm (0–100). The participants will be randomised to receive either a 12-week non-surgical treatment programme consisting of patient education, exercise, diet, insoles, paracetamol and/or NSAIDs or usual care (two information leaflets containing information on KOA and advice regarding the above non-surgical treatment). The primary outcome will be the change from baseline to 12 months on the self-report questionnaire Knee Injury and Osteoarthritis Outcome Score (KOOS)4 defined as the average score for the subscale scores for pain, symptoms, activities of daily living and quality of life. Secondary outcomes include the five individual KOOS subscale scores, pain on a 100 mm Visual Analogue Scale, EQ-5D, self-efficacy, pain pressure thresholds, postural control and isometric knee flexion and knee extension strength.
Ethics and dissemination
This study was approved by the local Ethics Committee of The North Denmark Region (N-20110085) and the protocol conforms to the principles of the Declaration of Helsinki. Data collection will be completed by April 2014. Publications will be ready for submission in the summer of 2014.
Trial registration number
This study is registered with http://clinicaltrials.gov (NCT01535001).
doi:10.1136/bmjopen-2012-002168
PMCID: PMC3533085  PMID: 23151395
Rheumatology; Rehabilitation Medicine
15.  OARSI/OMERACT Initiative to Define States of Severity and Indication for Joint Replacement in Hip and Knee Osteoarthritis. An OMERACT 10 Special Interest Group 
The Journal of Rheumatology  2011;38(8):1765-1769.
Objective
To define pain and physical function cutpoints that would, coupled with structural severity, define a surrogate measure of “need for joint replacement surgery,” for use as an outcome measure for potential structure-modifying interventions for osteoarthritis (OA).
Methods
New scores were developed for pain and physical function in knee and hip OA. A cross-sectional international study in 1909 patients was conducted to define data-driven cutpoints corresponding to the orthopedic surgeons’ indication for joint replacement. A post hoc analysis of 8 randomized clinical trials (1379 patients) evaluated the prevalence and validity of cutpoints, among patients with symptomatic hip/knee OA.
Results
In the international cross-sectional study, there was substantial overlap in symptom levels between patients with and patients without indication for joint replacement; indeed, it was not possible to determine cutpoints for pain and function defining this indication. The post hoc analysis of trial data showed that the prevalence of cases that combined radiological progression, high level of pain, and high degree of function impairment was low (2%–12%). The most discriminatory cutpoint to define an indication for joint replacement was found to be [pain (0–100) + physical function (0–100) > 80].
Conclusion
These results do not support a specific level of pain or function that defines an indication for joint replacement. However, a tentative cutpoint for pain and physical function levels is proposed for further evaluation. Potentially, this symptom level, coupled with radiographic progression, could be used to define “nonresponders” to disease-modifying drugs in OA clinical trials.
doi:10.3899/jrheum.110403
PMCID: PMC3260473  PMID: 21807799
OSTEOARTHRITIS; SEVERITY; PAIN; FUNCTION; STRUCTURE OUTCOME MEASURE
16.  Feasibility of 4 patient-reported outcome measures in a registry setting 
Acta Orthopaedica  2012;83(4):321-327.
Background and purpose
Feasibility is an important parameter when choosing which patient-reported outcomes (PRO) to use in a study. We assessed the feasibility of PROs in a hip registry setting.
Methods
Primary total hip arthroplasty (THA) patients (n = 5,747) who had been operated on 1–2, 5–6, or 10–11 years previously were randomly selected from the Danish Hip Arthroplasty Register and sent 2 PRO questionnaires: 1 generic (EuroQoL-5D or SF-12 health survey) and 1 disease-specific (hip dysfunction and osteoarthritis outcome score (HOOS) or Oxford 12-item hip score). We compared response rates, floor and ceiling effects, missing items, and the need for manual validation of forms.
Results
4,784 patients (mean age 71 years, 57% females) were included (83%). The response rates ranged from 82–84%. Statistically significantly different floor and ceiling effects ranged from 0% to 0.5% and from 6.1% to 46%, respectively. Missing items ranged from 1.2% to 3.4%, and 0.8–4.3% required manual validation (p < 0.009). A hypothetical repeat study found that group sizes from 51 to 1,566 are needed for subgroup analysis, depending on descriptive factor and choice of PRO.
Interpretation
All 4 PROs fulfilled a priori set criteria, with the exception of ceiling effects. The high ceiling effects were attributed to postoperative administration and good outcome for THA. We conclude that all 4 PROs are appropriate for administration in a hip registry.
doi:10.3109/17453674.2012.702390
PMCID: PMC3427620  PMID: 22900909
17.  A Hierarchy of Patient-Reported Outcomes for Meta-Analysis of Knee Osteoarthritis Trials: Empirical Evidence from a Survey of High Impact Journals 
Arthritis  2012;2012:136245.
Objectives. To develop a prioritised list based on responsiveness for extracting patient-reported outcomes (PROs) measuring pain and disability for performing meta-analyses in knee osteoarthritis (OA). Methods. A systematic search was conducted in 20 highest impact factor general and rheumatology journals chosen a priori. Eligible studies were randomised controlled trials, using two or more PROs measuring pain and/or disability. Results. A literature search identified 402 publications and 38 trials were included, resulting in 54 randomised comparisons. Thirty-five trials had sufficient data on pain and 15 trials on disability. The WOMAC “pain” and “function” subscales were the most responsive composite scores. The following list was developed. Pain: (1) WOMAC “pain” subscale, (2) pain during activity (VAS), (3) pain during walking (VAS), (4) general knee pain (VAS), (5) pain at rest (VAS), (6) other composite pain scales, and (7) other single item measures. Disability: (1) WOMAC “function” subscale, (2) SF-36 “physical function” subscale, (3) SF-36 (Physical composite score), and (4) Other composite disability scores. Conclusions. As choosing the PRO most favourable for the intervention from individual trials can lead to biased estimates, using a prioritised list as developed in this study is recommended to reduce risk of biased selection of PROs in meta-analyses.
doi:10.1155/2012/136245
PMCID: PMC3389647  PMID: 22792458
18.  Effect of leisure time physical activity on severe knee or hip osteoarthritis leading to total joint replacement: a population-based prospective cohort study 
Background
Studies on leisure time physical activity as risk factor or protective factor for knee or hip osteoarthritis (OA) show divergent results. Longitudinal prospective studies are needed to clarify the association of physical activity with future OA. The aim was to explore in a prospective population-based cohort study the influence of leisure time physical activity on severe knee or hip OA, defined as knee or hip replacement due to OA.
Methods
Leisure time physical activity was reported by 28320 participants (mean age 58 years (SD 7.6), 60% women) at baseline. An overall leisure time physical activity score, taking both duration and intensity of physical activities into account, was created. The most commonly reported activities were also used for analysis. The incidence of knee or hip replacement due to OA over 11 years was monitored by linkage with the Swedish hospital discharge register. Cox’s proportional hazards model (crude and adjusted for potential confounding factors) was used to assess the incidence of total joint replacement, or osteotomy (knee), in separate analyses of leisure time physical activity.
Results
There was no significant overall association between leisure time physical activity and risk for knee or hip replacement due to OA over the 11-year observation time. For women only, the adjusted RR (95% CI) for hip replacement was 0.66 (0.48, 0.89) (fourth vs. first quartile), indicating a lower risk of hip replacement in those with the highest compared with the lowest physical activity. The most commonly reported activities were walking, bicycling, using stairs, and gardening. Walking was associated with a lower risk of hip replacement (adjusted RR 0.76 (95% CI 0.61, 0.94), specifically for women (adjusted RR 0.75 (95% CI 0.57, 0.98)).
Conclusions
In this population-based study of middle-aged men and women, leisure time physical activity showed no consistent overall relationship with incidence of severe knee or hip OA, defined as joint replacement due to OA, over 11 years. For women, higher leisure time physical activity may have a protective role for the incidence of hip replacement. Walking may have a protective role for hip replacement, specifically for women.
doi:10.1186/1471-2474-13-73
PMCID: PMC3462680  PMID: 22595023
Osteoarthritis; Arthroplasty; Exercise; Workload; Risk factors
19.  Principles of brain plasticity in improving sensorimotor function of the knee and leg in patients with anterior cruciate ligament injury: a double-blind randomized exploratory trial 
Background
Severe traumatic knee injury, including injury to the anterior cruciate ligament (ACL), leads to impaired sensorimotor function. Although improvements are achieved by training, impairment often persists. Because good sensorimotor function is associated with better patient-reported function and a potential lower risk of future joint problems, more effective treatment is warranted. Temporary cutaneous anesthesia of adjacent body parts was successfully used on the hand and foot to improve sensorimotor function. The aim of this study was to test whether this principle of brain plasticity could be used on the knee. The hypothesis was that temporary anesthesia of the skin area above and below the knee would improve sensorimotor function of the ipsilateral knee and leg in subjects with ACL injury.
Methods
In this double-blind exploratory study, 39 subjects with ACL injury (mean age 24 years, SD 5.2, 49% women, mean 52 weeks after injury or reconstruction) and self-reported functional limitations and lack of trust in the knee were randomized to temporary local cutaneous application of anesthetic (EMLA®) (n = 20) or placebo cream (n = 19). Fifty grams of EMLA®, or placebo, was applied on the leg 10 cm above and 10 cm below the center of patella, leaving the area around the knee without cream. Measures of sensory function (perception of touch, vibration sense, knee kinesthesia) and motor function (knee muscle strength, hop test) were assessed before and after 90 minutes of treatment with EMLA® or placebo. The paired t-test was used for comparisons within groups and analysis of variance between groups, except for ordinal data where the Wilcoxon signed rank test, or Mann–Whitney test, was used. The number of subjects needed was determined by an a priori sample size calculation.
Results
No statistically significant or clinically relevant differences were seen over time (before vs. after) in the measures of sensory or motor functions in the EMLA® group or in the placebo group. There were no differences between the groups due to treatment effect (EMLA® vs. placebo).
Conclusions
Temporary cutaneous anesthesia of adjacent body parts had no effect in improving sensorimotor function of the knee and leg in subjects with severe traumatic knee ligament injury.
doi:10.1186/1471-2474-13-68
PMCID: PMC3441769  PMID: 22574814
20.  Total knee replacement plus physical and medical therapy or treatment with physical and medical therapy alone: a randomised controlled trial in patients with knee osteoarthritis (the MEDIC-study) 
Background
There is a lack of high quality evidence concerning the efficacy of total knee arthroplasty (TKA). According to international evidence-based guidelines, treatment of knee osteoarthritis (KOA) should include patient education, exercise and weight loss. Insoles and pharmacological treatment can be included as supplementary treatments. If the combination of these non-surgical treatment modalities is ineffective, TKA may be indicated. The purpose of this randomised controlled trial is to examine whether TKA provides further improvement in pain, function and quality of life in addition to optimised non-surgical treatment in patients with KOA defined as definite radiographic OA and up to moderate pain.
Methods/Design
The study will be conducted in The North Denmark Region. 100 participants with radiographic KOA (K-L grade ≥2) and mean pain during the previous week of ≤ 60 mm (0–100, best to worst scale) who are considered eligible for TKA by an orthopaedic surgeon will be included. The treatment will consist of 12 weeks of optimised non-surgical treatment consisting of patient education, exercise, diet, insoles, analgesics and/or NSAIDs. Patients will be randomised to either receiving or not receiving a TKA in addition to the optimised non-surgical treatment. The primary outcome will be the change from baseline to 12 months on the Knee Injury and Osteoarthritis Outcome Score (KOOS)4 defined as the average score for the subscale scores for pain, symptoms, activities of daily living, and quality of life. Secondary outcomes include the five individual KOOS subscale scores, EQ-5D, pain on a 100 mm Visual Analogue Scale, self-efficacy, pain pressure thresholds, and isometric knee flexion and knee extension strength.
Discussion
This is the first randomised controlled trial to investigate the efficacy of TKA as an adjunct treatment to optimised non-surgical treatment in patients with KOA. The results will significantly contribute to evidence-based recommendations for the treatment of patients with KOA.
Trial registration
Clinicaltrials.gov reference: NCT01410409
doi:10.1186/1471-2474-13-67
PMCID: PMC3461437  PMID: 22571284
21.  Early intervention for adolescents with Patellofemoral Pain Syndrome - a pragmatic cluster randomised controlled trial 
Background
Self-reported knee pain is highly prevalent among adolescents. As much as 50% of the non-specific knee pain may be attributed to Patellofemoral Pain Syndrome (PFPS). In the short term, exercise therapy appears to have a better effect than patient education consisting of written information and general advice on exercise or compared with placebo treatment. But the long-term effect of exercise therapy compared with patient education is conflicting. The purpose of this study is to examine the short- and long-term effectiveness of patient education compared with patient education and multimodal physiotherapy applied at a very early stage of the condition among adolescents.
Methods/Design
This study is a single blind pragmatic cluster randomised controlled trial. Four upper secondary schools have been invited to participate in the study (approximately 2500 students, aged 15-19 years). Students are asked to answer an online questionnaire regarding musculoskeletal pain. The students who report knee pain are contacted by telephone and offered a clinical examination by a rheumatologist. Subjects who fit the inclusion criteria and are diagnosed with PFPS are invited to participate in the study. A minimum of 102 students with PFPS are then cluster-randomised into two intervention groups based on which school they attend. Both intervention groups receive written information and education. In addition to patient education, one group receives multimodal physiotherapy consisting primarily of neuromuscular training of the muscles around the foot, knee and hip and home exercises.
The students with PFPS fill out self-reported questionnaires at baseline, 3, 6, 12 and 24 months after inclusion in the study. The primary outcome measure is perception of recovery measured on a 7-point Likert scale ranging from "completely recovered" to "worse than ever" at 12 months.
Discussion
This study is designed to investigate the effectiveness of patient education compared with patient education combined with multimodal physiotherapy. If patient education and multimodal physiotherapy applied at an early stage of Patellofemoral Pain Syndrome proves effective, it may serve as a basis for optimising the clinical pathway for those suffering from the condition, where specific emphasis can be placed on early diagnosis and early treatment.
Trial Registration
clinicaltrials.gov reference: NCT01438762
doi:10.1186/1471-2474-13-9
PMCID: PMC3328242  PMID: 22280484
Patellofemoral Pain Syndrome; Anterior Knee Pain; Physiotherapy; Adolescents
22.  Comparison of neuromuscular and quadriceps strengthening exercise in the treatment of varus malaligned knees with medial knee osteoarthritis: a randomised controlled trial protocol 
Background
Osteoarthritis of the knee involving predominantly the medial tibiofemoral compartment is common in older people, giving rise to pain and loss of function. Many people experience progressive worsening of the disease over time, particularly those with varus malalignment and increased medial knee joint load. Therefore, interventions that can reduce excessive medial knee loading may be beneficial in reducing the risk of structural progression. Traditional quadriceps strengthening can improve pain and function in people with knee osteoarthritis but does not appear to reduce medial knee load. A neuromuscular exercise program, emphasising optimal alignment of the trunk and lower limb joints relative to one another, as well as quality of movement performance, while dynamically and functionally strengthening the lower limb muscles, may be able to reduce medial knee load. Such a program may also be superior to traditional quadriceps strengthening with respect to improved pain and physical function because of the functional and dynamic nature. This randomised controlled trial will investigate the effect of a neuromuscular exercise program on medial knee joint loading, pain and function in individuals with medial knee joint osteoarthritis. We hypothesise that the neuromuscular program will reduce medial knee load as well as pain and functional limitations to a greater extent than a traditional quadriceps strengthening program.
Methods/Design
100 people with medial knee pain, radiographic medial compartment osteoarthritis and varus malalignment will be recruited and randomly allocated to one of two 12-week exercise programs: quadriceps strengthening or neuromuscular exercise. Each program will involve 14 supervised exercise sessions with a physiotherapist plus four unsupervised sessions per week at home. The primary outcomes are medial knee load during walking (the peak external knee adduction moment from 3D gait analysis), pain, and self-reported physical function measured at baseline and immediately following the program. Secondary outcomes include the external knee adduction moment angular impulse, electromyographic muscle activation patterns, knee and hip muscle strength, balance, functional ability, and quality-of-life.
Discussion
The findings will help determine whether neuromuscular exercise is superior to traditional quadriceps strengthening regarding effects on knee load, pain and physical function in people with medial knee osteoarthritis and varus malalignment.
Trial Registration
Australian New Zealand Clinical Trials Registry reference: ACTRN12610000660088
doi:10.1186/1471-2474-12-276
PMCID: PMC3247187  PMID: 22141334
23.  Non-surgical treatment of hip osteoarthritis. Hip school, with or without the addition of manual therapy, in comparison to a minimal control intervention: Protocol for a three-armed randomized clinical trial 
Background
Hip osteoarthritis is a common and chronic condition resulting in pain, functional disability and reduced quality of life. In the early stages of the disease, a combination of non-pharmacological and pharmacological treatment is recommended. There is evidence from several trials that exercise therapy is effective. In addition, single trials suggest that patient education in the form of a hip school is a promising intervention and that manual therapy is superior to exercise.
Methods/Design
This is a randomized clinical trial. Patients with clinical and radiological hip osteoarthritis, 40-80 years of age, and without indication for hip surgery were randomized into 3 groups. The active intervention groups A and B received six weeks of hip school, taught by a physiotherapist, for a total of 5 sessions. In addition, group B received manual therapy consisting of joint manipulation and soft-tissue therapy twice a week for six weeks. Group C received a self-care information leaflet containing advice on "live as usual" and stretching exercises from the hip school. The primary time point for assessing relative effectiveness is at the end of the six weeks intervention period with follow-ups after three and 12 months.
Primary outcome measure is pain measured on an eleven-point numeric rating scale. Secondary outcome measures are the hip dysfunction and osteoarthritis outcome score, patient's global perceived effect, patient specific functional scale, general quality of life and hip range of motion.
Discussion
To our knowledge this is the first randomized clinical trial comparing a patient education program with or without the addition of manual therapy to a minimal intervention for patients with hip osteoarthritis.
Trial registration
ClinicalTrials NCT01039337
doi:10.1186/1471-2474-12-88
PMCID: PMC3112433  PMID: 21542914
24.  Validity and inter-rater reliability of medio-lateral knee motion observed during a single-limb mini squat 
Background
Muscle function may influence the risk of knee injury and outcomes following injury. Clinical tests, such as a single-limb mini squat, resemble conditions of daily life and are easy to administer. Fewer squats per 30 seconds indicate poorer function. However, the quality of movement, such as the medio-lateral knee motion may also be important. The aim was to validate an observational clinical test of assessing the medio-lateral knee motion, using a three-dimensional (3-D) motion analysis system. In addition, the inter-rater reliability was evaluated.
Methods
Twenty-five (17 women) non-injured participants (mean age 25.6 years, range 18-37) were included. Visual analysis of the medio-lateral knee motion, scored as knee-over-foot or knee-medial-to-foot by two raters, and 3-D kinematic data were collected simultaneously during a single-limb mini squat. Frontal plane 2-D peak tibial, thigh, and knee varus-valgus angles, and 3-D peak hip internal-external rotation, and knee varus-valgus angles were calculated.
Results
Ten subjects were scored as having a knee-medial-to-foot position and 15 subjects a knee-over-foot position assessed by visual inspection. In 2-D, the peak tibial angle (mean 89.0 (SE 0.7) vs mean 86.3 (SE 0.4) degrees, p = 0.001) and peak thigh angle (mean 77.4 (SE 1.0) vs mean 81.2 (SE 0.5) degrees, p = 0.001) with respect to the horizontal, indicated that the knee was more medially placed than the ankle and thigh, respectively. Thus, the knee was in more valgus (mean 11.6 (SE 1.5) vs 5.0 (SE 0.8) degrees, p < 0.001) in subjects with the knee-medial-to-foot than in those with a knee-over-foot position. In 3-D, the hip was more internally rotated in those with a knee-medial-to-foot than in those with a knee-over-foot position (mean 10.6 (SE 2.1) vs 4.8 (SE 1.8) degrees, p = 0.049), but there was no difference in knee valgus (mean 6.1 (SE 1.8) vs mean 5.0 (SE 1.2) degrees, p = 0.589). The kappa value and percent agreement, respectively, was >0.90 and 96 between raters.
Conclusions
Medio-lateral motion of the knee can reliably be assessed during a single-leg mini-squat. The test is valid in 2-D, while the actual movement, in 3-D, is mainly exhibited as increased internal hip rotation. The single-limb mini squat is feasible and easy to administer in the clinical setting and in research to address lower extremity movement quality.
doi:10.1186/1471-2474-11-265
PMCID: PMC2998461  PMID: 21080945
25.  Relationships between postural orientation and self reported function, hop performance and muscle power in subjects with anterior cruciate ligament injury 
Background
Injury to the anterior cruciate ligament (ACL) is associated not only with knee instability and impaired neuromuscular control, but also with altered postural orientation manifested as observable "substitution patterns". However, tests currently used to evaluate knee function in subjects with ACL injury are not designed to assess postural orientation. Therefore, we are in the process of developing an observational test set that measures postural orientation in terms of the ability to stabilize body segments in relation to each other and to the environment. The aim of the present study was to characterise correlations between this novel test set, called the Test for Substitution Patterns (TSP) and commonly used tests of knee function.
Methods
In a blinded set-up, 53 subjects (mean age 30 years, range 20-39, with 2-5 years since ACL injury) were assessed using the TSP, the Knee Injury and Osteoarthritis Outcome Score subscale sport/recreation (KOOS sport/rec), 3 hop tests and 3 muscle power tests. Correlations between the scores of the TSP and the other tests were determined.
Results
Moderate correlations were found between TSP scores and KOOS sport/rec (rs = -0.43; p = 0.001) and between TSP scores and hop test results (rs = -0.40 to -0.46; p ≤ 0.003), indicating that altered postural orientation was associated with worse self-reported KOOS sport/rec function and worse hop performance. No significant correlations were found between TSP scores and muscle power results. Subjects had higher TSP scores on their injured side than on their uninjured side (median 4 and 1 points; interquartile range 2-6 and 0-1.5, respectively; p < 0.0001).
Conclusions
We conclude that the Test for Substitution Patterns is of relevance to the patient and measures a specific aspect of neuromuscular control not quantified by the other tests investigated. We suggest that the TSP may be a valuable complement in the assessment of neuromuscular control in the rehabilitation of subjects with ACL injury.
doi:10.1186/1471-2474-11-143
PMCID: PMC2908077  PMID: 20594339

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