Conditions: Osteoarthritis of the Knee
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief summary:
The objectives of the study are 1.) to evaluate pain relief following the application of the Bioskin Ten-7 knee brace and 2.) to determine if use of the Bioskin Ten-7 knee brace is more effective at reducing inflammation than standard of care alone using synovial fluid cytokine analysis and validated outcome measures.

Detailed description:
Once consented, the patient is assigned to either Group A or Group B. Group A patients will receive standard treatment only and will not be prescribed a knee brace. Group B patients will receive standard treatment and the Bioskin Ten-7 knee brace. On Day 0, the patient will be assigned to one of the 2 groups using a 1:1 assignment. VAS, WOMAC, Oxford Knee Score, KOOS questionnaires will be administered and a sample of the patient's synovial fluid will be sent to labs for cytokine and cell count analysis. All patients will record use of NSAIDs and for Group B, the start and end time of brace use will be recorded. All patients will return in 8 weeks to assess efficacy of treatment. All patients will return their diaries, complete the same validated outcome measures as Day 0 and undergo a repeat synovial fluid analysis.

Arms:
arm 1: Group A will receive standard treatment only such as NSAIDs and injections arm 2: Group B will receive standard treatment such as NSAIDs and injections and the Bioskin Ten-7 knee brace.

Interventions: intervention 1: Standard treatment only intervention 2: Standard treatment plus Bioskin Ten-7 knee brace
Intervention descriptions: intervention 1: Standard treatment such as NSAIDs and injections intervention 2: Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.

Protocol document: