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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Drug: Standard treatment only; Device: Standard treatment plus Bioskin Ten-7 knee brace

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Treatment Only; Group A will receive standard treatment only such as NSAIDs and injections	Drug: Standard treatment only; Standard treatment such as NSAIDs and injections; Other Names: NSAIDs and injections
Experimental: Standard Treatment plus Bioskin Ten-7; Group B will receive standard treatment such as NSAIDs and injections and the Bioskin Ten-7 knee brace.	Drug: Standard treatment only; Standard treatment such as NSAIDs and injections; Other Names: NSAIDs and injections; Device: Standard treatment plus Bioskin Ten-7 knee brace; Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cropper Medical
• Investigators: Principal Investigator: Vinod Dasa, MD, LSUHSC-NO, Orthopaedic Department

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (Estimate): November 19, 2014

Study Record Updates

• Last Update Posted (Estimate): July 11, 2016
• Last Update Submitted That Met QC Criteria: June 1, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 8627 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No