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PRP in ACLR to Prevent PTOA

NCT05412381 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-02-13

No results posted yet for this study

Summary

The purpose of our study is to examine the effect of platelet-rich-plasma (PRP) injection on the short-term resolution of post-injury inflammation (biomarkers) and improvement in joint function in patients with acute ACL injury. This RCT has been powered based on the questionnaire KOOS Jr. but it is considered a 'pilot study' in terms of the lab analysis proposed.

Conditions

  • Anterior Cruciate Ligament Injuries
  • Post-traumatic Osteoarthritis
  • PRP

Interventions

PROCEDURE

platelet rich plasma (PRP) injection

We aim to evaluate early catabolic and inflammatory changes in knee joints in patients receiving PRP injections following ACL injury, as these patients are at higher risk of developing PTOA. We also aim to establish correlations between markers of biologic activity of PRP and clinical outcomes (including both patient-reported outcomes and clinical functional outcomes), with emphasis on cellular and molecular inflammatory parameters modulated by PRP.

PROCEDURE

placebo saline injection

Patients randomized into the control arm will receive the placebo or saline injection

Sponsors & Collaborators

  • Orthopedic Research and Education Foundation

    collaborator OTHER

  • Hospital for Special Surgery, New York

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-27
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05412381 on ClinicalTrials.gov