N/A
Completed N=51
Efficacy Study of an Unloading Brace for Knee Osteoarthritis
Source: ClinicalTrials.gov NCT02150057 ↗Enrolled (actual)
51
Serious AEs
4.9%
Results posted
Oct 2019
Primary outcomePrimary: Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score — 2.92; 2.86; 3.03; 2.67 units on a scale — p=<0.05
Summary
Subjects with symptomatic unicompartmental osteoarthritis of the knee will be invited to participate in this randomized study. Subjects will be assigned to either a Fusion Osteoarthritis Knee Brace group, or a control group that does not wear a brace. It is hypothesized that use of the Fusion Osteoarthritis Knee Brace will have a better outcome on osteoarthritis knee pain and quality of life compared to those who do not receive bracing intervention.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score |
2.92; 2.86; 3.03; 2.67 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Age 30-80.
- History of medial unicompartmental knee pain > 3 months duration (medial compartment only).
- Narrowing of medial joint space 10 degrees as compared to the contralateral limb.
- Flexion limitation > 20 degrees.
- Significant soft tissue compromise preventing long-term brace use.
- Peripheral vascular disease or other neurovascular complaints.
- Leg-length discrepancy > 2cm.
Data sourced from ClinicalTrials.gov (NCT02150057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.