Osteoarthritis of the Knee
Conditions
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.
Interventions
Standard treatment such as NSAIDs and injections
DEVICEStandard treatment plus Bioskin Ten-7 knee brace
Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
Sponsors
Cropper Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KOOS - Pain | Week 8- Day 0 | Value at 8 weeks - value at day 0 |
| KOOS - Symptoms | Week 8 - Day 0 | Value at 8 weeks - value at day 0 |
| KOOS - ADL | week 8 - day 0 | Value at 8 weeks - value at day 0 |
| KOOS - Sport/Rec | Week 8 - day 0 | Value at 8 weeks - value at day 0 |
| KOOS - QOL | Week 8 - day 0 | Value at 8 weeks - value at day 0 |
| Synovial Fluid Analysis (IL-6) | Week 8 - day 0 | Interleukine 6 in Synovial fluid analysis |
| Synovial Fluid Analysis (IL-8) | Week 8 - day 0 | Interleukine 8 in Synovial fluid analysis |
| Synovial Fluid Analysis (TNF-alpha) | Week 8 - day 0 | Tumor necrosis factor - alpha in Synovial fluid analysis |
| Synovial Fluid Analysis (MIP - 1alpha) | Week 8 - day 0 | Macrophage Inflammatory Proteins - 1alpha |
| Synovial Fluid Analysis (MCP - 1) | Week 8 -day 0 | Monocyte chemotactic protein-1 - 1 |
| Oxford Knee Score | Day 0 and Week 8 | — |
| WOMAC | Day 0 and Week 8 | assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index |
| Visual Analog Scale | Day 0 and Week 8 | identifies pain level |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Treatment Only Standard treatment only such as NSAIDs and injections | 20 |
| Standard Treatment Plus Bioskin Ten-7 Knee Brace Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Total | Standard Treatment Only | Standard Treatment Plus Bioskin Ten-7 Knee Brace |
|---|---|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 10.2 | 57.4 years STANDARD_DEVIATION 11.3 | 61.5 years STANDARD_DEVIATION 8.8 |
| Body Mass Index | 32.4 kg/m^2 STANDARD_DEVIATION 5.4 | 34.2 kg/m^2 STANDARD_DEVIATION 5.8 | 30.4 kg/m^2 STANDARD_DEVIATION 4.3 |
| IL-6 | 1467.1 pg/mL | 1639 pg/mL | 1309 pg/mL |
| IL-8 | 643.0 pg/mL | 653.3 pg/mL | 486.5 pg/mL |
| KOOS - ADL | 39.0 units on a scale STANDARD_DEVIATION 19.1 | 40.8 units on a scale STANDARD_DEVIATION 15.6 | 37.2 units on a scale STANDARD_DEVIATION 22.2 |
| KOOS - Pain | 35.6 units on a scale STANDARD_DEVIATION 19.4 | 37.8 units on a scale STANDARD_DEVIATION 18.7 | 33.5 units on a scale STANDARD_DEVIATION 20.3 |
| KOOS - QOL | 20.9 units on a scale STANDARD_DEVIATION 18 | 28.7 units on a scale STANDARD_DEVIATION 19.6 | 14.4 units on a scale STANDARD_DEVIATION 13.8 |
| KOOS - Sport/Rec | 19.8 units on a scale STANDARD_DEVIATION 22.9 | 29.3 units on a scale STANDARD_DEVIATION 25.9 | 12.1 units on a scale STANDARD_DEVIATION 17.1 |
| KOOS - Symptoms | 40.4 units on a scale STANDARD_DEVIATION 20.1 | 45.5 units on a scale STANDARD_DEVIATION 22.4 | 35.6 units on a scale STANDARD_DEVIATION 16.7 |
| MCP-1 | 10188 pg/mL | 8664 pg/mL | 10944 pg/mL |
| MIP-1alpha | 250.8 pg/mL | 255.5 pg/mL | 162.2 pg/mL |
| Region of Enrollment United States | 40 participants | 20 participants | 20 participants |
| Sex: Female, Male Female | 29 Participants | 13 Participants | 16 Participants |
| Sex: Female, Male Male | 11 Participants | 7 Participants | 4 Participants |
| Standard of care Medications | 20 participants | 4 participants | 16 participants |
| Standard of care NSAID | 18 participants | 14 participants | 4 participants |
| Standard of care Surpatz | 2 participants | 2 participants | 0 participants |
| TNF-alpha | 108.1 pg/mL | 108.1 pg/mL | 104.8 pg/mL |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 1 / 20 |
Outcome results
Primary
KOOS - ADL
Value at 8 weeks - value at day 0
Time frame: week 8 - day 0
Population: Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Standard Treatment Only | KOOS - ADL | 15.3 units on a scale |
| Standard Treatment Plus Bioskin Ten-7 Knee Brace | KOOS - ADL | 9.8 units on a scale |
p-value: 0.311t-test, 2 sided
Primary
KOOS - Pain
Value at 8 weeks - value at day 0
Time frame: Week 8- Day 0
Population: Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Standard Treatment Only | KOOS - Pain | 17.6 units on a scale |
| Standard Treatment Plus Bioskin Ten-7 Knee Brace | KOOS - Pain | 9.1 units on a scale |
p-value: 0.181t-test, 2 sided
Primary
KOOS - QOL
Value at 8 weeks - value at day 0
Time frame: Week 8 - day 0
Population: Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Standard Treatment Only | KOOS - QOL | 11.0 pg/mL |
| Standard Treatment Plus Bioskin Ten-7 Knee Brace | KOOS - QOL | 5.4 pg/mL |
p-value: 0.449t-test, 2 sided
Primary
KOOS - Sport/Rec
Value at 8 weeks - value at day 0
Time frame: Week 8 - day 0
Population: Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Standard Treatment Only | KOOS - Sport/Rec | 13.8 units on a scale |
| Standard Treatment Plus Bioskin Ten-7 Knee Brace | KOOS - Sport/Rec | 9.6 units on a scale |
Primary
KOOS - Symptoms
Value at 8 weeks - value at day 0
Time frame: Week 8 - Day 0
Population: Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Standard Treatment Only | KOOS - Symptoms | 10.6 units on a scale |
| Standard Treatment Plus Bioskin Ten-7 Knee Brace | KOOS - Symptoms | 3.2 units on a scale |
p-value: 0.232t-test, 2 sided
Primary
Oxford Knee Score
Time frame: Day 0 and Week 8
Population: The outcome was not measured as KOOS was measured as the only patient reported outcome.
Primary
Synovial Fluid Analysis (IL-6)
Interleukine 6 in Synovial fluid analysis
Time frame: Week 8 - day 0
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Treatment Only | Synovial Fluid Analysis (IL-6) | -453.8 pg/mL |
| Standard Treatment Plus Bioskin Ten-7 Knee Brace | Synovial Fluid Analysis (IL-6) | -1055 pg/mL |
p-value: 0.86Wilcoxon (Mann-Whitney)
Primary
Synovial Fluid Analysis (IL-8)
Interleukine 8 in Synovial fluid analysis
Time frame: Week 8 - day 0
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Treatment Only | Synovial Fluid Analysis (IL-8) | -379.8 pg/mL |
| Standard Treatment Plus Bioskin Ten-7 Knee Brace | Synovial Fluid Analysis (IL-8) | -488.9 pg/mL |
p-value: 0.735Wilcoxon (Mann-Whitney)
Primary
Synovial Fluid Analysis (MCP - 1)
Monocyte chemotactic protein-1 - 1
Time frame: Week 8 -day 0
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Treatment Only | Synovial Fluid Analysis (MCP - 1) | -7170 pg/mL |
| Standard Treatment Plus Bioskin Ten-7 Knee Brace | Synovial Fluid Analysis (MCP - 1) | -4890 pg/mL |
p-value: 0.878Wilcoxon (Mann-Whitney)
Primary
Synovial Fluid Analysis (MIP - 1alpha)
Macrophage Inflammatory Proteins - 1alpha
Time frame: Week 8 - day 0
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Treatment Only | Synovial Fluid Analysis (MIP - 1alpha) | -246.7 pg/mL |
| Standard Treatment Plus Bioskin Ten-7 Knee Brace | Synovial Fluid Analysis (MIP - 1alpha) | -49.8 pg/mL |
p-value: 0.323Wilcoxon (Mann-Whitney)
Primary
Synovial Fluid Analysis (TNF-alpha)
Tumor necrosis factor - alpha in Synovial fluid analysis
Time frame: Week 8 - day 0
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Treatment Only | Synovial Fluid Analysis (TNF-alpha) | -97.4 pg/mL |
| Standard Treatment Plus Bioskin Ten-7 Knee Brace | Synovial Fluid Analysis (TNF-alpha) | -51.7 pg/mL |
p-value: 0.479Wilcoxon (Mann-Whitney)
Primary
Visual Analog Scale
identifies pain level
Time frame: Day 0 and Week 8
Population: The outcome was not measured as KOOS was measured as the only patient reported outcome.
Primary
WOMAC
assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index
Time frame: Day 0 and Week 8
Population: The outcome was not measured as KOOS was measured as the only patient reported outcome.