- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02295020
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
Status
Completed
Conditions
Intervention / Treatment
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:
|
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:
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
Additional Relevant MeSH Terms
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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