ClinicalTrials.gov
ClinicalTrials.gov Menu

Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

December 26, 2017
January 3, 2018
March 30, 2018
June 2018
February 2020   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT03389685 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • ACL - Anterior Cruciate Ligament Rupture
  • ACL Injury
  • Biological: Platelet Rich Plasma
    Pure PRPII®, leukocyte-poor, platelet rich plasma
  • Other: Saline Placebo
    saline solution
  • Experimental: Platelet Rich Plasma
    Platelet Rich Plasma will be prepared using Genesis CS EmCyte PurePRP II system.
    Intervention: Biological: Platelet Rich Plasma
  • Placebo Comparator: Saline Placebo
    Unmarked syringe with 5 ml of saline
    Intervention: Other: Saline Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
Same as current
February 2020
February 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact: Hien Pham 646 501 7223 hien.pham@nyumc.org
United States
 
 
NCT03389685
16-02038
No
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
Not Provided
New York University School of Medicine
New York University School of Medicine
Not Provided
Principal Investigator: Eric Strauss, MD New York University School of Medicine
New York University School of Medicine
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP