Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-09

Study Completion Date

2024-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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ACL - Anterior Cruciate Ligament Rupture ACL Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Platelet Rich Plasma

Platelet Rich Plasma will be prepared using Genesis CS EmCyte PurePRP II system.

Group Type EXPERIMENTAL

Platelet Rich Plasma

Intervention Type BIOLOGICAL

Pure PRPII®, leukocyte-poor, platelet rich plasma

Saline Placebo

Unmarked syringe with 5 ml of saline

Group Type PLACEBO_COMPARATOR

Saline Placebo

Intervention Type OTHER

saline solution

Interventions

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Platelet Rich Plasma

Pure PRPII®, leukocyte-poor, platelet rich plasma

Intervention Type BIOLOGICAL

Saline Placebo

saline solution

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No