Trials / Completed
CompletedNCT04044612
Effect of Knee Bracing on Improving Pain & Disability
Effect of Knee Bracing on Improving Pain & Disability, Physical Performance, Physical Activity and Femoral Cartilage Deformation in Individuals With Medial Compartment Knee Osteoarthritis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- University of North Carolina, Chapel Hill · Academic / Other
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The overall purpose of the proposed pilot study is to establish the feasibility of conducting a clinical trial by evaluating the preliminary effects of 8 weeks of knee bracing on physiological measures of self-reported pain and disability, physical performance, physical activity, as well as femoral cartilage deformation in individuals with medial compartment knee osteoarthritis (OA). The investigators will recruit 36 symptomatic knee OA patients for the pilot study. The investigators will evaluate a class of braces (two different models will be used) designed to correct genu varum. The purpose of the study is to evaluate changes in these novel outcomes following the use of a class of braces used to reduce medial tibiofemoral compartment compression used for 8 weeks. This pilot study will inform a larger future trial to determine the efficacy of bracing on decreasing disability and disease progression in patients with knee osteoarthritis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Medial Unloader Brace | medial knee unloader braces use a three point bending system to increase space in the medial tibiofemoral compartment during weight bearing |
Timeline
- Start date
- 2018-12-01
- Primary completion
- 2020-03-31
- Completion
- 2020-03-31
- First posted
- 2019-08-05
- Last updated
- 2021-03-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04044612. Inclusion in this directory is not an endorsement.