Clinical trial NCT03460236: Precision Assessment of Platelet Rich Plasma for Joint Preservation
Official title: Precision Assessment of Platelet Rich Plasma for Joint Preservation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: PRP
osteoarthritis
MRI
gait
patient reported outcome
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-03-09
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment.

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Successful Knee Pain Improvement Over 6 Months Following PRP Injections
timeFrame: Baseline to 6 months
measure: Number of Participants With Successful Knee Function Improvement Over 6 Months Following PRP Injections
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Constance R. Chu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.