Lateral wedge insoles for medial knee osteoarthritis: 12 month randomised controlled trial
BMJPublished 18 May 2011Open access
Kim L. Bennell, Kelly‐Ann Bowles, Craig Payne, Flavia Cicuttini, Elizabeth Williamson, Andrew Forbes
Citations225
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TL;DR
Lateral wedge insoles worn for 12 months provided no symptomatic or structural benefits compared with flat control insoles, and none of the changes in secondary outcomes showed differences between groups.
Abstract
Lateral wedge insoles worn for 12 months provided no symptomatic or structural benefits compared with flat control insoles. Trial registration Australian New Zealand Clinical Trials Registry ACTR12605000503628 and ClinicalTrials.gov NCT00415259.
Keywords
MedicineEngineering
Journal of the American Statistical AssociationStatistical Analysis With Missing Data
17,489 Citations1989Maureen Lahiff, Roderick J. A. Little +1 more
Annals of the Rheumatic DiseasesRadiological Assessment of Osteo-Arthrosis
12,445 Citations1957Jan Kellgren, J. S. Lawrence
It was concluded that, to ensure maximum uniformity in grading x rays in field surveys and therapeutic trials, all readings should be made by the same observer, preferably at a single session.
PubMedValidation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee.
7,818 Citations1988Nicholas Bellamy, W. Watson Buchanan +3 more
WOMAC is a disease-specific purpose built high performance instrument for evaluative research in osteoarthritis clinical trials and fulfil conventional criteria for face, content and construct validity, reliability, responsiveness and relative efficiency.
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3,118 Citations1988Subir Ghosh, Roderick J. A. Little +1 more
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Preliminary results indicate the AQoL has the prerequisite qualities for a psychometric HRQoL instrument for evaluation; replication with a larger sample is needed to verify these findings.
PubMedRecommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III.
745 Citations1997Nicholas Bellamy, John Kirwan +8 more
A consensus was reached by at least 90% of participants that the following 4 domains should be evaluated in future phase III trials of knee, hip, and hand OA: pain, physical function, patient global assessment, and, for studies of one year or longer, joint imaging.
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Compared with placebo, glucosamine, chondroitin, and their combination do not reduce joint pain or have an impact on narrowing of joint space and health authorities and health insurers should not cover the costs.
Journal of Orthopaedic Research®The knee adduction moment during gait in subjects with knee osteoarthritis is more closely correlated with static alignment than radiographic disease severity, toe out angle and pain
553 Citations2002Debra E. Hurwitz, A. B. Ryals +3 more
While the mechanical axis was indicative of the peak adduction moments, it only accounted for about 50% of its variation, emphasizing the need for a dynamic evaluation of the knee joint loading environment.
PubMedAtlas of individual radiographic features in osteoarthritis.
431 Citations1995Roy D. Altman, M Hochberg +3 more
Radiographs of the hand, hip and knee were screened for evidence of osteoarthritis (OA) and a resultant atlas is offered as an updated guide to standardize interpretation of radiographs prior to and during clinical trials.
Osteoarthritis and CartilageMagnetic resonance imaging (MRI) of articular cartilage in knee osteoarthritis (OA): morphological assessment
410 Citations2006F. Eckstein, Flavia Cicuttini +3 more
MRI of cartilage has tremendous potential for large scale epidemiological studies of OA progression, and for clinical trials of treatment response to structure modifying OA drugs, with robust acquisition protocols for multi-center trials now being available.
Statistics in MedicineAdjusting for partially missing baseline measurements in randomized trials
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Joint modelling of baseline and outcome is the most efficient method, subject to three conditions, which are illustrated in a randomized trial in community psychiatry.
Archives of Physical Medicine and RehabilitationEffectiveness of a lateral-wedge insole on knee varus torque in patients with knee osteoarthritis
350 Citations2002D. Casey Kerrigan, Jennifer L. Lelas +4 more
Both wedge insoles are effective in reducing the varus torque during walking beyond what theoretically could be explained by a reduced walking speed or cushioning effect from the insole.
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PubMedPhysical Activity Scale for the Elderly (PASE): the relationship with activity measured by a portable accelerometer.
285 Citations1999Richard A. Washburn, Jennifer L. Ficker
The results of this study add to the literature supporting the validity of the PASE as a measure of physical activity in older individuals.
Journal of Orthopaedic Research®Knee pain and joint loading in subjects with osteoarthritis of the knee
280 Citations2000Debra E. Hurwitz, A. R. Ryals +4 more
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Annals of the Rheumatic DiseasesRate of cartilage loss at two years predicts subsequent total knee arthroplasty: a prospective study
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PubMedOsteoarthritis antirheumatic drug trials. III. Setting the delta for clinical trials--results of a consensus development (Delphi) exercise.
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In 2 studies, standardized procedures for conducting outcome measurement based on current Food and Drug Administration and European League Against Rheumatism guidelines for osteoarthritis clinical trials are developed, and the standard deviation for these outcome measures is determined.
PubMedOsteoarthritis clinical trials: candidate variables and clinimetric properties.
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The following review provides a description of candidate variables that merit consideration in reaching international harmonization on outcome measures for future OA clinical trials.
Osteoarthritis and CartilageResponsiveness and reliability of MRI in knee osteoarthritis: a meta-analysis of published evidence
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PubMedUse of lateral heel and sole wedges in the treatment of medial osteoarthritis of the knee.
139 Citations1993E. Michael Keating, Philip M. Faris +2 more
It appears that the use of lateral wedges has a place in the conservative treatment of medial osteoarthritis and even patients with complete loss of joint space and bony erosion showed some improvement.
Arthritis & RheumatismComparison of tibial cartilage volume and radiologic grade of the tibiofemoral joint
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Clinical BiomechanicsContribution of knee adduction moment impulse to pain and disability in Japanese women with medial knee osteoarthritis
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89 Citations2008Monica R. Maly, Patrick A. Costigan +1 more
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