Precision Assessment of Platelet Rich Plasma for Joint Preservation

VA Office of Research and Development

Status

Completed

Conditions

Osteoarthritis

Study type

Observational

Funder types

Other U.S. Federal agency

Identifiers

NCT03460236

43655 (Other Identifier)

F2452-R

Details and patient eligibility

About

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.

Full 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

Enrollment

90 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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