Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury

NCT03389685 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 16-02038
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL - Anterior Cruciate Ligament Rupture; ACL Injury

Keywords

Platelet Rich Plasma

Outcome Measures

Primary Outcomes (1)

• synovial fluid biomarker levels

  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)

  2 Days

Study Arms (2)

Platelet Rich Plasma

EXPERIMENTAL

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

Biological: Platelet Rich Plasma

Saline Placebo

PLACEBO COMPARATOR

Unmarked syringe with 5 ml of saline

Other: Saline Placebo

Interventions

Platelet Rich Plasma BIOLOGICAL

Pure PRPII®, leukocyte-poor, platelet rich plasma

Platelet Rich Plasma

Saline Placebo OTHER

saline solution

Saline Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Eric Strauss, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: January 3, 2018
• Study Start: September 9, 2018
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

US (1)