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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03389685

Enrollment

Registered

2018-01-03

Start date

2018-09-09

Completion date

2024-02-29

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL - Anterior Cruciate Ligament Rupture, ACL Injury

Keywords

Platelet Rich Plasma

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.

Interventions

BIOLOGICALPlatelet Rich Plasma

Pure PRPII®, leukocyte-poor, platelet rich plasma

OTHERSaline Placebo

saline solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
synovial fluid biomarker levels	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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026