PRP in ACLR to Prevent PTOA

Part of paid clinical trials in New York, New York.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT05412381
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
14 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • platelet rich plasma (PRP) injection — PROCEDURE
    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.
  • placebo saline injection — PROCEDURE
    Patients randomized into the control arm will receive the placebo or saline injection

Study Details

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.

Key Dates

Start date
Jun 27, 2022
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Control Arm
    The control arm will receive a pre-op placebo injection of saline, and ACLR surgery with intra-op placebo injection
  • Experimental: Investigational Arm
    The investigational arm will receive a pre-op PRP injection, and ACLR surgery with PRP injection

Primary Outcome Measure

Platelet count (Thousand/uL) [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital for Special SurgeryNew YorkNew York10021
Jessica Andres-Bergos, PhD
[email protected]
9172604694

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