Precision Assessment of Platelet Rich Plasma for Joint Preservation

NCT ID: NCT03460236

Last Updated: 2025-05-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-02

Study Completion Date

2024-03-31

Brief Summary

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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

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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

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PRP

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Constance R. Chu, MD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Locations

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VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 37202126 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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43655

Identifier Type: OTHER

Identifier Source: secondary_id

F2452-R

Identifier Type: -

Identifier Source: org_study_id

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