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

June 1, 2016 updated by: Cropper Medical
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

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Vinod Dasa, MD, LSUHSC-NO, Orthopaedic Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 8627 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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