Recruiting
Phase 3

PRP

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT05412381

Conditions

Anterior Cruciate Ligament Injuries

Post-traumatic Osteoarthritis

PRP

Eligibility Criteria

Sex: All

Age: 14 - 50

Healthy Volunteers: Not accepted

Interventions

platelet rich plasma (PRP) injection

placebo saline injection

Study Details

Brief 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

Study ID

NCT05412381

Start date

Jun 27, 2022

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

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.

placebo saline injection

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

Primary outcome measure

  • Platelet count (Thousand/uL) [ Time Frame: Baseline ]
  • Platelet count (Thousand/uL) [ Time Frame: during the procedure ]
  • Knee Injury and Osteoarthritis Outcome (KOOS-JR) [ Time Frame: Baseline ]
  • Knee Injury and Osteoarthritis Outcome (KOOS-JR) [ Time Frame: during the procedure ]
  • Knee Injury and Osteoarthritis Outcome (KOOS-JR) [ Time Frame: 2 weeks post-op ]
  • Knee Injury and Osteoarthritis Outcome (KOOS-JR) [ Time Frame: 6 weeks post-op ]
  • Knee Injury and Osteoarthritis Outcome (KOOS-JR) [ Time Frame: 6 months post-op ]
  • Knee Injury and Osteoarthritis Outcome (KOOS-JR) [ Time Frame: 12 months post-op ]
  • Knee Injury and Osteoarthritis Outcome (KOOS-JR) [ Time Frame: 24 months post-op ]
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: Baseline ]
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: during the procedure ]
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: 6 weeks post-op ]
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: 6 months post-op ]
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: 12 months post-op ]
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: 24 months post-op ]
  • Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) [ Time Frame: Baseline ]
  • Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) [ Time Frame: during the procedure ]
  • Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) [ Time Frame: 2 weeks post-op ]
  • Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) [ Time Frame: 6 weeks post-op ]
  • Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) [ Time Frame: 6 months post-op ]
  • Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) [ Time Frame: 12 months post-op ]
  • Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) [ Time Frame: 24 months post-op ]
  • Single Assessment Numeric Evaluation (SANE) [ Time Frame: Baseline ]
  • Single Assessment Numeric Evaluation (SANE) [ Time Frame: during the procedure ]
  • Single Assessment Numeric Evaluation (SANE) [ Time Frame: 2 weeks post-op ]
  • Single Assessment Numeric Evaluation (SANE) [ Time Frame: 6 weeks post-op ]
  • Single Assessment Numeric Evaluation (SANE) [ Time Frame: 6 months post-op ]
  • Single Assessment Numeric Evaluation (SANE) [ Time Frame: 12 months post-op ]
  • Single Assessment Numeric Evaluation (SANE) [ Time Frame: 24 months post-op ]

Central Contacts and Locations

Central contacts

Jessica Andres-Bergos, PhD

(917) 260-4694andresbergosj@hss.edu

Locations

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Jessica Andres-Bergos, PhD

9172604694andresbergosj@hss.edu

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Feb 13, 2026

Last verified

Jan, 2026

Keywords

  • platelet-rich plasma
  • regenerative medicine
  • anterior cruciate ligament reconstruction
  • post-traumatic osteoarthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2026-02-13.