RecruitingPhase 3NCT05412381

PRP in ACLR to Prevent PTOA

Platelet Rich Plasma (PRP) Treatment of the Anterior Cruciate Ligament Injured Knee to Decrease the Risk of Post-traumatic Osteoarthritis (PTOA): a Randomized Double-blind Controlled Trial


Sponsor

Hospital for Special Surgery, New York

Enrollment

56 participants

Start Date

Jun 27, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 14 YearsMax Age: 50 Years

Inclusion Criteria4

  • Acute ACL injury within 6 weeks of presentation
  • Age 14-50
  • Male or female
  • Meniscus injury that can be treated with meniscectomy or repair (the lack of meniscus injury will not exclude patients)

Exclusion Criteria9

  • Prior ACL reconstruction
  • Prior cartilage repair procedure
  • Prior meniscus surgery within 12 months
  • Prior steroid, hyaluronic acid, or PRP injection within 6 months
  • Other ligament injury requiring repair
  • Any cartilage lesion requiring repair
  • Any cartilage lesion greater than grade 2 (partial thickness injury)
  • History of inflammatory arthritis or joint sepsis
  • Non English speakers

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Interventions

PROCEDUREplatelet 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.

PROCEDUREplacebo saline injection

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


Locations(1)

Hospital for Special Surgery

New York, New York, United States

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NCT05412381


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