NCT03389685

Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury

Can Platelet Rich Plasma Reduce the Level of Pro-Inflammatory Synovial Fluid Biomarkers Following an Anterior Cruciate Ligament Tear

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ACL - Anterior Cruciate Ligament Rupture
• ACL Injury

Interventions

Type	Name	Description
BIOLOGICAL	Platelet Rich Plasma	Pure PRPII®, leukocyte-poor, platelet rich plasma
OTHER	Saline Placebo	saline solution

Timeline

• Start date: 2018-09-09
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2018-01-03
• Last updated: 2024-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study