Osteoarthritis of the Knee Clinical Trial
— BioskinOfficial title:
Bioskin Cytokine Study
Verified date | April 2016 |
Source | Cropper Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cropper Medical |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale | identifies pain level | Day 0 and Week 8 | No |
Primary | Western Ontario and McMaster universities Osteoarthritis Index (WOMAC) | assess pain, stiffness, and physical function | Day 0 and Week 8 | No |
Primary | Oxford Knee Score | Day 0 and Week 8 | No | |
Primary | KOOS | Day 0 and Week 8 | No | |
Primary | Synovial fluid analysis | Day 0 and Week 8 | No |
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