At a glance
ClinicalIndex Comparison Record- ✓Must meet American College of Rheumatology (ACR) criteria for osteoarthritis with knee pain, aching or stiffness on most of the past 30 days and evidence on radiograph of a definite osteophyte.
- ✓Evidence of medial knee osteoarthritis on radiograph with medial compartment disease (definite radiographic OA + at least grade 1 medial narrowing on 0-3 scale using OARSI atlas), without lateral compartment or patellofemoral compartment disease.
- ✓WOMAC pain score of at least 4 out of 10 on at least 2 of 5 questions, or a total of greater than 15 out of 50 on the pain scale, measured at both pre-randomization phone call/visit and randomization visit.
- ✓Must pass 4-week run-in test.
- ✕Clinical evidence of patellofemoral disease or other knee pathology (besides medial compartment OA) likely causing knee pain.
- ✕Regular use of ambulation aids (cane, crutch, walker, or wheelchair).
- ✕Amputation of foot or previous major trauma to foot; foot lesions (sores or ulcers) where load redistribution could be dangerous.
- ✕Known peripheral neuropathy (from diabetes or other causes).
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Trial of Realignment Therapy for Treatment of Medial Knee Osteoarthritis
In Brief
A clinical study evaluating Realigning knee brace and custom orthodic and Non realigning knee brace and flat orthodic for Knee Osteoarthritis. Completed, enrolled 80 participants across 1 site.
Detailed Summary
The overall objective of this 3-year project is to determine whether the provision of realignment therapy in patients with medial knee osteoarthritis (OA) relieves knee pain and improves function. The researchers will test the hypothesis that compared to control treatment, the use of realignment therapy (valgus knee brace + motion control shoes + orthosis) is effective in medial knee OA. The specific aims are: * To undertake a 30 week randomized crossover clinical trial in patients with medial knee osteoarthritis to determine whether provision of realignment therapy leads to lower pain scores and improved function during the time of this treatment than during the use of a placebo treatment; * To perform an open label follow-up study to track use and effectiveness of treatment. This project will be co-funded by DonJoy Orthopedic, a knee bracing company.
Study Details
Timeline
Interventions
A valgus brace, customized functional orthotic for neutral foot position and motion control footwear
A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole