Palo Alto, California 94304

  • Osteoarthritis

Purpose:

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.


Study summary:

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


Criteria:

Inclusion Criteria: - symptomatic early knee OA - full weight-bearing status - have elected to receive PRP treatment - Male veterans - Female veterans or non-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


NCT ID:

NCT03460236


Primary Contact:

Principal Investigator
Constance R. Chu, MD
VA Palo Alto Health Care System, Palo Alto, CA

Jennifer Erhart-Hledik, PhD
Phone: (650) 493-5000 ext. 62388
Email: jerhart@stanford.edu


Backup Contact:

Email: gmahtani@stanford.edu
Gordhan B Mahtani, MSc
Phone: (650) 493-5000 ext. 64431


Location Contact:

Palo Alto, California 94304
United States

Gordhan B Mahtani, MSc
Phone: 650-493-5000
Email: gmahtani@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 17, 2021

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