Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury

ACL Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03389685
• Other study ID #: 16-02038
• Status: Withdrawn
• Phase: Phase 2
• Start date: September 9, 2018
• Est. completion date: February 2024

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL - Anterior Cruciate Ligament Rupture
• ACL Injury
• Anterior Cruciate Ligament Injuries
• Rupture

Intervention

Biological:
• Platelet Rich Plasma
Pure PRPII®, leukocyte-poor, platelet rich plasma

Other:
• Saline Placebo
saline solution

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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