Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.

Cropper Medical

Status: Completed

Conditions: Osteoarthritis of the Knee

Treatments: Device: Standard treatment plus Bioskin Ten-7 knee brace; Drug: Standard treatment only

Study type: Interventional

Funder types: Industry

Identifiers

NCT02295020

8627 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female 18 years and older with primary diagnosis of Knee OA with no other knee diagnosis.
• Must have telephone access.

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Standard Treatment Only

Active Comparator group

Description:

Group A will receive standard treatment only such as NSAIDs and injections

Treatment:

Drug: Standard treatment only

Standard Treatment plus Bioskin Ten-7

Experimental group

Description:

Group B will receive standard treatment such as NSAIDs and injections and the Bioskin Ten-7 knee brace.

Treatment:

Drug: Standard treatment only

Device: Standard treatment plus Bioskin Ten-7 knee brace