Osteoarthritis
Conditions
Keywords
PRP, osteoarthritis, MRI, gait, patient reported outcome
Brief summary
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.
Detailed description
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
Interventions
None listed
Sponsors
VA Office of Research and Development
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* symptomatic early knee OA * full weight-bearing status * have elected to receive PRP treatment * Male veterans * Female veterans
Exclusion criteria
* inflammatory arthritis, gout or recurrent pseudogout * symptomatic OA of other lower extremity joints * BMI \>35 kg/m2 * use of walking, orthopedic, or prosthetic assistive device * severe systemic disease defined as American Society of Anesthesiologists (ASA) 3 or above56 * inability to have MRI * pregnant or intending to become pregnant during the study * predominantly patellofemoral disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Knee Pain Improvement Over 6 Months Following PRP Injections | Baseline to 6 months | 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. |
| Number of Participants With Successful Knee Function Improvement Over 6 Months Following PRP Injections | Baseline to 6 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
After enrollment, 16 failed radiographic screening before assignment to the study.
Participants by arm
| Arm | Count |
|---|---|
| Platelet Rich Plasma Injection Group Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment. | 90 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | failed radiographic screening | 16 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | Platelet Rich Plasma Injection Group |
|---|---|
| Age, Continuous | 55 years |
| Body Mass Index | 27.78499 kg/m² |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 68 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 90 |
| other Total, other adverse events | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 |
Outcome results
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.
Time frame: Baseline to 6 months
Population: The 63 participants who completed both baseline and 6-month follow-up patient reported outcome surveys.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Platelet Rich Plasma (PRP) Recipients | Number of Participants With Successful Knee Function Improvement Over 6 Months Following PRP Injections | 12 Participants |
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.
Time frame: Baseline to 6 months
Population: The 63 participants who completed both baseline and 6-month follow-up patient reported outcome surveys.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Platelet Rich Plasma (PRP) Recipients | Number of Participants With Successful Knee Pain Improvement Over 6 Months Following PRP Injections | 25 Participants |