The purpose of this study is to assess the effect of the Unloader one brace on the clinical symptoms of patients with knee osteoarthritis (OA) by comparing a functioning brace with a dummy.
The purpose of this study is to assess the effect of the Unloader one brace on the clinical symptoms of patients with knee OA by comparing a functioning brace with a dummy. The dummy will be manufactured by Össur and has the same look as the real brace, but lacks the fundamental tightening effect of the straps of the real brace (an insert of elastic bands assures this), thereby nullifying its unloading capabilities. In a recent trial by Dr. Ingvarsson, the brace seemed to lessen the pain from knee OA, but no randomised, controlled studies have been conducted. This is mandatory if the effect of the brace and its use as an accepted treatment for knee OA is to be advocated for general use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
A knee brace used to unload affected compartments in osteoarthritic knees
A knee brace that feels and looks like Unloader One but without active straps facilitating unloading of the knee
Orthopeadic Clinic Hässlehlm Hospital
Hässleholm, Skåne County, Sweden
Knee injury and Osteoarthritis Outcome Score (KOOS)
Standardized questionaire for knee problems, divided into 5 subscores of pain, symptoms, activity of daily living, sports/recreation and quality of life. Each subscore is presented from 0 (worst) to 100 (best).
Time frame: one year
Knee Society Score (KSS)
Standardized outcome measure for knee problems presented in two subgroups of KSS Score and KSS Function, presented on a range from 0 (worst) to 100 (best)
Time frame: one year
Visual Analogue Scale (VAS)
VAS is presented as a range from 0 (no pain) to 100 (worst possible pain)
Time frame: one year
EQ-5D
EQ-5D comprises two distinct self-report elements, providing three principal approaches to analysis(1) the EQ-5D profile: the patients' self reported health on the dimensions/levels of the descriptive system (2) the EQ-VAS: the patients' own global rating of their overall health, on a scale from 0 (worst possible health) to100 (best possible health)• Both types of data can be the focus of analysis, plus(3) Profiles can be summarized using 'value sets' (EQ-5DIndex) which reflect the preferences of the general public.
Time frame: one year
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