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| ID | Type | Description | Link |
|---|---|---|---|
| 43655 | Other Identifier | IRB protocol number |
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Knee Osteoarthritis (OA) is a leading cause of premature disability in Veterans who develop knee OA at higher rates and younger ages than the population in general. For those with symptomatic early knee OA, who are years to decades away from meeting clinical indications for knee replacement surgery, knee injections have been a key treatment option. In recent years, platelet rich plasma (PRP) injections have gained increasing attention for improving pain and function in patients with knee OA. Basic science studies also suggest that PRP may also potentially stimulate repair responses to articular cartilage. However, the mechanisms of action of PRP in the treatment of knee OA are unknown. Because autologous blood is used, the PRP composition differs between patients. It is also unknown whether these differences in PRP composition affect clinical outcomes. This study will address these gaps and provide critical new and objective information on PRP treatment effects in Veterans and additional women with early knee OA important to improving clinical use of this new treatment.
Because very little is known about either the mechanisms of action or objective clinical outcomes of PRP treatment for knee OA, the investigators propose a prospective "pre-post" study that will permit us to identify areas where more rigorous clinical outcomes and mechanistic research may be warranted. The proposed work includes special elements of: (1) quantitative metrics to assess clinical outcomes, (2) correlation of candidate beneficial proteins with clinical outcomes, and (3) proteomic evaluation of the injected PRP. This work will use an innovative multi-disciplinary, personalized approach to evaluate the effects of PRP composition on both function, as assessed by patient-reported outcomes and gait analysis, and cartilage matrix structure as assessed by quantitative MRI
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP | Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Knee Pain Improvement Over 6 Months Following PRP Injections | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain scores were determined through standardized questionnaires to evaluate osteoarthritis of the knee. The KOOS Pain scale consists of 9 questions with each response valued on an ordinal scale 0-4. KOOS Pain scores are transformed so that higher scores indicate less pain. Successful pain improvement is determined from the number of participants with changes in KOOS Pain in excess of the previously determined threshold of 12.4pts for minimal important change after non-surgical intervention for knee pain. | Baseline to 6 months |
| Number of Participants With Successful Knee Function Improvement Over 6 Months Following PRP Injections | Knee Function was determined from Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores, standardized questionnaires to evaluate osteoarthritis of the knee. The WOMAC Function scale consists of 17 questions, with each response valued on an ordinal scale of 0-4. Higher numbers indicate more physical disability. Successful functional improvement is determined from the number of participants with changes in the WOMAC Function score in excess of the previously determined threshold of -17pts for minimal important functional change after non-surgical intervention. | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Constance R. Chu, MD | VA Palo Alto Health Care System, Palo Alto, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37202126 | Result | Silva MDC, Perriman DM, Fearon AM, Couldrick JM, Scarvell JM. Minimal important change and difference for knee osteoarthritis outcome measurement tools after non-surgical interventions: a systematic review. BMJ Open. 2023 May 18;13(5):e063026. doi: 10.1136/bmjopen-2022-063026. |
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After enrollment, 16 failed radiographic screening before assignment to the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Platelet Rich Plasma | Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Males and females with early knee osteoarthritis pain.
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| ID | Title | Description |
|---|---|---|
| BG000 | Platelet Rich Plasma Injection Group | Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Participants With Successful Knee Pain Improvement Over 6 Months Following PRP Injections | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain scores were determined through standardized questionnaires to evaluate osteoarthritis of the knee. The KOOS Pain scale consists of 9 questions with each response valued on an ordinal scale 0-4. KOOS Pain scores are transformed so that higher scores indicate less pain. Successful pain improvement is determined from the number of participants with changes in KOOS Pain in excess of the previously determined threshold of 12.4pts for minimal important change after non-surgical intervention for knee pain. | The 63 participants who completed both baseline and 6-month follow-up patient reported outcome surveys. | Posted | Count of Participants | Participants | Baseline to 6 months |
|
6 months
The principal investigator and team followed participants for 6 months and reported adverse events to the IRB immediately, if there were any.
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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 | Platelet Rich Plasma (PRP) Recipients | Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Hoang, Clinical Research Coordinator | Stanford University | 650-721-7630 | c1hoang@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 28, 2025 | Apr 28, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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One tube of blood identified with a unique number.
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index | Mean | Full Range | kg/m² |
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Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment.
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| Primary | Number of Participants With Successful Knee Function Improvement Over 6 Months Following PRP Injections | Knee Function was determined from Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores, standardized questionnaires to evaluate osteoarthritis of the knee. The WOMAC Function scale consists of 17 questions, with each response valued on an ordinal scale of 0-4. Higher numbers indicate more physical disability. Successful functional improvement is determined from the number of participants with changes in the WOMAC Function score in excess of the previously determined threshold of -17pts for minimal important functional change after non-surgical intervention. | The 63 participants who completed both baseline and 6-month follow-up patient reported outcome surveys. | Posted | Count of Participants | Participants | Baseline to 6 months |
|
|
|
| 0 |
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
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