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Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury

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ClinicalTrials.gov Identifier: NCT03389685
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
ACL - Anterior Cruciate Ligament Rupture ACL Injury Biological: Platelet Rich Plasma Other: Saline Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Can Platelet Rich Plasma Reduce the Level of Pro-Inflammatory Synovial Fluid Biomarkers Following an Anterior Cruciate Ligament Tear
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389685


Contacts
Contact: Hien Pham 646 501 7223 hien.pham@nyumc.org

Locations
United States, New York
New York University School of Medicine Not yet recruiting
New York, New York, United States, 10016
Contact: Hien Pham    646-501-7223    hien.pham@nyumc.org   
Principal Investigator: Eric Strauss, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Eric Strauss, MD New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03389685     History of Changes
Other Study ID Numbers: 16-02038
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

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

Keywords provided by New York University School of Medicine:
Platelet Rich Plasma

Additional relevant MeSH terms:
Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries