Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury

NYU Langone Health

Status and phase: Withdrawn; Phase 2

Conditions: ACL Injury; ACL - Anterior Cruciate Ligament Rupture

Treatments: Biological: Platelet Rich Plasma; Other: Saline Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03389685

16-02038

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Platelet Rich Plasma

Experimental group

Description:

Platelet Rich Plasma will be prepared using Genesis CS EmCyte PurePRP II system.

Treatment:

Biological: Platelet Rich Plasma

Saline Placebo

Placebo Comparator group

Description:

Unmarked syringe with 5 ml of saline

Treatment:

Other: Saline Placebo