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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment Only | Active Comparator | Group A will receive standard treatment only such as NSAIDs and injections |
|
| Standard Treatment plus Bioskin Ten-7 | Experimental | Group B will receive standard treatment such as NSAIDs and injections and the Bioskin Ten-7 knee brace. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard treatment only | Drug | Standard treatment such as NSAIDs and injections |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Vinod Dasa, MD | LSUHSC-NO, Orthopaedic Department | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Treatment Only. | Group A will receive standard treatment only Standard treatment: Standard treatment such as NSAIDs and injections |
| FG001 | Standard Treatment Plus Bioskin Ten-7. | Group B will receive standard treatment and the Bioskin Ten-7 knee brace. Standard treatment: Standard treatment such as NSAIDs and injections Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Treatment Only | Standard treatment only such as NSAIDs and injections |
| BG001 | Standard Treatment Plus Bioskin Ten-7 Knee Brace | Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | KOOS - Pain | Value at 8 weeks - value at day 0 | Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 8- Day 0 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Group A will receive standard treatment only Standard treatment: Standard treatment such as NSAIDs and injections |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CVA | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vinod Dasa | LSUHSC-NO -Orthopaedic Department | (504) 412-1700 | vdasa@lsuhsc.edu |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D007267 | Injections |
| ID | Term |
|---|---|
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
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| Standard treatment plus Bioskin Ten-7 knee brace | Device | Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace. |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Standard of care | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| KOOS - Pain | KOOS = Knee injury and Osteoarthritis Outcome Score. Pain refers to the pain sub-score.The scale is 0 to 100 where 100 indicates no problems and 0 indicates extreme problems. | Mean | Standard Deviation | units on a scale |
|
| KOOS - Symptoms | KOOS = Knee injury and Osteoarthritis Outcome Score. Symptoms refers to the Symptoms sub-score.The scale is 0 to 100 where 100 indicates no problems and 0 indicates extreme problems. | Mean | Standard Deviation | units on a scale |
|
| KOOS - ADL | KOOS = Knee injury and Osteoarthritis Outcome Score. ADL refers to the activities of daily living sub-score. The scale is 0 to 100 where 100 indicates no problems and 0 indicates extreme problems. | Mean | Standard Deviation | units on a scale |
|
| KOOS - Sport/Rec | KOOS = Knee injury and Osteoarthritis Outcome Score. Sport/Rec refers to the sport and recreational activities sub-score. The scale is 0 to 100 where 100 indicates no problems and 0 indicates extreme problems. | Mean | Standard Deviation | units on a scale |
|
| KOOS - QOL | KOOS = Knee injury and Osteoarthritis Outcome Score. QOL refers to the quality of life sub-score. The scale is 0 to 100 where 100 indicates no problems and 0 indicates extreme problems. | Mean | Standard Deviation | units on a scale |
|
| IL-6 | Median | Full Range | pg/mL |
|
| IL-8 | Median | Full Range | pg/mL |
|
| TNF-alpha | Median | Full Range | pg/mL |
|
| MIP-1alpha | Median | Full Range | pg/mL |
|
| MCP-1 | Median | Full Range | pg/mL |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | KOOS - Symptoms | Value at 8 weeks - value at day 0 | Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 8 - Day 0 |
|
|
|
|
| Primary | KOOS - ADL | Value at 8 weeks - value at day 0 | Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | week 8 - day 0 |
|
|
|
|
| Primary | KOOS - Sport/Rec | Value at 8 weeks - value at day 0 | Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 8 - day 0 |
|
|
|
| Primary | KOOS - QOL | Value at 8 weeks - value at day 0 | Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey. | Posted | Least Squares Mean | 95% Confidence Interval | pg/mL | Week 8 - day 0 |
|
|
|
|
| Primary | Synovial Fluid Analysis (IL-6) | Interleukine 6 in Synovial fluid analysis | Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed. | Posted | Median | Full Range | pg/mL | Week 8 - day 0 |
|
|
|
|
| Primary | Synovial Fluid Analysis (IL-8) | Interleukine 8 in Synovial fluid analysis | Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed. | Posted | Median | Full Range | pg/mL | Week 8 - day 0 |
|
|
|
|
| Primary | Synovial Fluid Analysis (TNF-alpha) | Tumor necrosis factor - alpha in Synovial fluid analysis | Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed. | Posted | Median | Full Range | pg/mL | Week 8 - day 0 |
|
|
|
|
| Primary | Synovial Fluid Analysis (MIP - 1alpha) | Macrophage Inflammatory Proteins - 1alpha | Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed. | Posted | Median | Full Range | pg/mL | Week 8 - day 0 |
|
|
|
|
| Primary | Synovial Fluid Analysis (MCP - 1) | Monocyte chemotactic protein-1 - 1 | Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed. | Posted | Median | Full Range | pg/mL | Week 8 -day 0 |
|
|
|
|
| Primary | Oxford Knee Score | The outcome was not measured as KOOS was measured as the only patient reported outcome. | Posted | Day 0 and Week 8 |
|
|
| Primary | WOMAC | assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index | The outcome was not measured as KOOS was measured as the only patient reported outcome. | Posted | Day 0 and Week 8 |
|
|
| Primary | Visual Analog Scale | identifies pain level | The outcome was not measured as KOOS was measured as the only patient reported outcome. | Posted | Day 0 and Week 8 |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Group B | Group B will receive standard treatment and the Bioskin Ten-7 knee brace. Standard treatment: Standard treatment such as NSAIDs and injections Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace | 1 | 20 | 0 | 20 |
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| D012216 |
| Rheumatic Diseases |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |