Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury

April 12, 2024 updated by: NYU Langone Health

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platelet Rich Plasma
Platelet Rich Plasma will be prepared using Genesis CS EmCyte PurePRP II system.
Biological: Platelet Rich Plasma
Pure PRPII®, leukocyte-poor, platelet rich plasma
Placebo Comparator: Saline Placebo
Unmarked syringe with 5 ml of saline
Other: Saline Placebo
saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
synovial fluid biomarker levels
Time Frame: 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)
2 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Eric Strauss, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2018

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

December 26, 2017

First Submitted That Met QC Criteria

December 26, 2017

First Posted (Actual)

January 3, 2018

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-02038

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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