Precision Assessment of Platelet Rich Plasma for Joint Preservation

NCT03460236 | Completed Results

• 2 other identifiers: F2452-R43655
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

PRP; osteoarthritis; MRI; gait; patient reported outcome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

PRP

Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment.

You may qualify if:

• symptomatic early knee OA
• full weight-bearing status
• have elected to receive PRP treatment
• Male veterans
• Female veterans

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Related Publications (1)

• 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.

  PMID: 37202126 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

One tube of blood identified with a unique number.

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Christine Hoang, Clinical Research Coordinator
• Organization: Stanford University

c1hoang@stanford.edu

650-721-7630

Study Officials

• Constance R. Chu, MD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: March 9, 2018
• Study Start: April 2, 2018
• Primary Completion: March 29, 2024
• Study Completion: March 31, 2024
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)