Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine. (Bioskin)
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard treatment only
Standard treatment plus Bioskin Ten-7 knee brace
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee
Eligibility Criteria
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:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Treatment Only
Standard Treatment plus Bioskin Ten-7
Arm Description
Group A will receive standard treatment only such as NSAIDs and injections
Group B will receive standard treatment such as NSAIDs and injections and the Bioskin Ten-7 knee brace.
Outcomes
Primary Outcome Measures
KOOS - Pain
Value at 8 weeks - value at day 0
KOOS - Symptoms
Value at 8 weeks - value at day 0
KOOS - ADL
Value at 8 weeks - value at day 0
KOOS - Sport/Rec
Value at 8 weeks - value at day 0
KOOS - QOL
Value at 8 weeks - value at day 0
Synovial Fluid Analysis (IL-6)
Interleukine 6 in Synovial fluid analysis
Synovial Fluid Analysis (IL-8)
Interleukine 8 in Synovial fluid analysis
Synovial Fluid Analysis (TNF-alpha)
Tumor necrosis factor - alpha in Synovial fluid analysis
Synovial Fluid Analysis (MIP - 1alpha)
Macrophage Inflammatory Proteins - 1alpha
Synovial Fluid Analysis (MCP - 1)
Monocyte chemotactic protein-1 - 1
Oxford Knee Score
WOMAC
assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index
Visual Analog Scale
identifies pain level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02295020
Brief Title
Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.
Acronym
Bioskin
Official Title
Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cropper Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Treatment Only
Arm Type
Active Comparator
Arm Description
Group A will receive standard treatment only such as NSAIDs and injections
Arm Title
Standard Treatment plus Bioskin Ten-7
Arm Type
Experimental
Arm Description
Group B will receive standard treatment such as NSAIDs and injections and the Bioskin Ten-7 knee brace.
Intervention Type
Drug
Intervention Name(s)
Standard treatment only
Other Intervention Name(s)
NSAIDs and injections
Intervention Description
Standard treatment such as NSAIDs and injections
Intervention Type
Device
Intervention Name(s)
Standard treatment plus Bioskin Ten-7 knee brace
Intervention Description
Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
Primary Outcome Measure Information:
Title
KOOS - Pain
Description
Value at 8 weeks - value at day 0
Time Frame
Week 8- Day 0
Title
KOOS - Symptoms
Description
Value at 8 weeks - value at day 0
Time Frame
Week 8 - Day 0
Title
KOOS - ADL
Description
Value at 8 weeks - value at day 0
Time Frame
week 8 - day 0
Title
KOOS - Sport/Rec
Description
Value at 8 weeks - value at day 0
Time Frame
Week 8 - day 0
Title
KOOS - QOL
Description
Value at 8 weeks - value at day 0
Time Frame
Week 8 - day 0
Title
Synovial Fluid Analysis (IL-6)
Description
Interleukine 6 in Synovial fluid analysis
Time Frame
Week 8 - day 0
Title
Synovial Fluid Analysis (IL-8)
Description
Interleukine 8 in Synovial fluid analysis
Time Frame
Week 8 - day 0
Title
Synovial Fluid Analysis (TNF-alpha)
Description
Tumor necrosis factor - alpha in Synovial fluid analysis
Time Frame
Week 8 - day 0
Title
Synovial Fluid Analysis (MIP - 1alpha)
Description
Macrophage Inflammatory Proteins - 1alpha
Time Frame
Week 8 - day 0
Title
Synovial Fluid Analysis (MCP - 1)
Description
Monocyte chemotactic protein-1 - 1
Time Frame
Week 8 -day 0
Title
Oxford Knee Score
Time Frame
Day 0 and Week 8
Title
WOMAC
Description
assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index
Time Frame
Day 0 and Week 8
Title
Visual Analog Scale
Description
identifies pain level
Time Frame
Day 0 and Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinod Dasa, MD
Organizational Affiliation
LSUHSC-NO, Orthopaedic Department
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.
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