Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury

Phase 2

Withdrawn

• Conditions: ACL - Anterior Cruciate Ligament Rupture; ACL Injury
• Interventions: Biological: Platelet Rich Plasma; Other: Saline Placebo

• Registration Number: NCT03389685
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this single-center, double-blinded randomized control trial with prospective data collection is to assess the ability of platelet rich plasma (PRP) treatment to reduce the level of pro-inflammatory synovial fluid biomarkers following an acute anterior cruciate ligament (ACL) tear. The study will collect and analyze synovial fluid of patients presenting with an acute anterior cruciate ligament (ACL) tear with a second synovial fluid sampling at the time of surgery. It will compare synovial fluid biomarker levels between those receiving an intra-articular Platelet Rich Plasma (PRP) injection versus an intra-articular saline injection serving as a control. Post-operative clinical outcomes will also be assessed, including post-operative pain levels, incidence of post-operative knee stiffness and patient reported outcome scores.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2017-12-26
• Study First Posted: 2018-01-03
• Study Start: 2018-09-09
• Primary Completion: 2024-02
• Study Completion: 2024-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients have suffered an acute ACL tear (initial presentation within 7 days of injury) with or without an associated meniscus injury
• Patient must undergo ACL reconstruction surgery

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Exclusion Criteria

• Mentally impaired (e.g, Alzheimer's subjects, dementia, etc.)
• Younger than 18 years of age
• Patients who have a multiligamentous injury
• Patients with underlying inflammatory arthropathies
• Previous ACL injury and/or reconstruction

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet Rich Plasma	Platelet Rich Plasma	Platelet Rich Plasma will be prepared using Genesis CS EmCyte PurePRP II system.
Saline Placebo	Saline Placebo	Unmarked syringe with 5 ml of saline

Primary Outcome Measures

Name	Time	Method
synovial fluid biomarker levels	2 Days	The synovial fluid samples obtained at the two time points will be analyzed for the presence of 20 biomarkers using a multiplex bead assay (Milliplex®, Millipore, Billerica MA)

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States