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

Not Applicable

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Drug: Standard treatment only; Device: Standard treatment plus Bioskin Ten-7 knee brace

• Registration Number: NCT02295020
• Lead Sponsor: Cropper Medical

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-18
• Study First Posted: 2014-11-19
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Results First Submitted: 2016-04-08
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-01
• Last Update Submitted: 2016-06-01
• Results First Posted: 2016-07-11
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment plus Bioskin Ten-7	Standard treatment only	Group B will receive standard treatment such as NSAIDs and injections and the Bioskin Ten-7 knee brace.
Standard Treatment Only	Standard treatment only	Group A will receive standard treatment only such as NSAIDs and injections
Standard Treatment plus Bioskin Ten-7	Standard treatment plus Bioskin Ten-7 knee brace	Group B will receive standard treatment such as NSAIDs and injections and the Bioskin Ten-7 knee brace.

Primary Outcome Measures

Name	Time	Method
Synovial Fluid Analysis (IL-8)	Week 8 - day 0	Interleukine 8 in Synovial fluid analysis
Synovial Fluid Analysis (TNF-alpha)	Week 8 - day 0	Tumor necrosis factor - alpha in Synovial fluid analysis
Synovial Fluid Analysis (MIP - 1alpha)	Week 8 - day 0	Macrophage Inflammatory Proteins - 1alpha
Synovial Fluid Analysis (MCP - 1)	Week 8 -day 0	Monocyte chemotactic protein-1 - 1
Oxford Knee Score	Day 0 and Week 8
KOOS - Pain	Week 8- Day 0	Value at 8 weeks - value at day 0
KOOS - Symptoms	Week 8 - Day 0	Value at 8 weeks - value at day 0
KOOS - ADL	week 8 - day 0	Value at 8 weeks - value at day 0
KOOS - Sport/Rec	Week 8 - day 0	Value at 8 weeks - value at day 0
KOOS - QOL	Week 8 - day 0	Value at 8 weeks - value at day 0
Synovial Fluid Analysis (IL-6)	Week 8 - day 0	Interleukine 6 in Synovial fluid analysis
WOMAC	Day 0 and Week 8	assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index
Visual Analog Scale	Day 0 and Week 8	identifies pain level