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| Name | Class |
|---|---|
| Lund University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unloader One brace | Active Comparator | Patients receiving an active brace, Unloader One with active straps facilitating unloading of affected knee compartment |
|
| Placebo brace | Placebo Comparator | Patients receiving a dummy, lookalike or placebo brace without active straps that facilitate unloading of the affected knee compartment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unloader One brace | Device | A knee brace used to unload affected compartments in osteoarthritic knees |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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) | one year |
| Visual Analogue Scale (VAS) | VAS is presented as a range from 0 (no pain) to 100 (worst possible pain) | 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. | one year |
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Inclusion Criteria:
Patients fulfilling all criteria listed below will be considered to eligible for participation in the study:
Exclusion Criteria:
Patient presenting with any of the following will not be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Soren Toksvig-Larsen, Ass prof | Orthopeadic Clinic Hassleholm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopeadic Clinic Hässlehlm Hospital | Hässleholm | Skåne County | 28138 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30243296 | Derived | Hjartarson HF, Toksvig-Larsen S. The clinical effect of an unloader brace on patients with osteoarthritis of the knee, a randomized placebo controlled trial with one year follow up. BMC Musculoskelet Disord. 2018 Sep 22;19(1):341. doi: 10.1186/s12891-018-2256-7. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Two groups with same problem of osteoarthritis in knee
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| Placebo brace | Device | A knee brace that feels and looks like Unloader One but without active straps facilitating unloading of the knee |
|
| D012216 |
| Rheumatic Diseases |