Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears

NCT04088227 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ACL-PRP Study
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A potential long-term consequence of anterior cruciate ligament injuries is the development of post-traumatic osteoarthritis in the years following injury. There are no curative treatments for osteoarthritis, increasing the importance of minimizing the occurrence of post-traumatic osteoarthritis following anterior cruciate ligament injuries. Current literature has begun to indicate that biochemical changes in the knee joint cartilage, such as chondrocyte death, following injury can contribute to the development of post-traumatic osteoarthritis. The main objective of this study is to determine if an early intervention of joint aspiration and platelet rich plasma injection will positively affect the biomarkers representative of chondral degeneration in patients with anterior cruciate ligament injuries. We hypothesize that the intervention will reduce the volume of inflammatory and chondrodegenerative biomarkers following anterior cruciate ligament injury.

Conditions

Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

• Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration

  The presence of the Synovial Interleukin (IL) -1 Receptor Antagonist biomarker in the synovial fluid will be assessed.

  Timepoint 1: initial visit (within 10 days of injury) Timepoint 2: at the time of surgery (within 4 weeks of injury)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

The control group will have a joint aspiration performed at an initial visit (within the first 10 days after injury), and at the time of surgery (within 4 weeks of injury).

Other: Control Group

Experimental Group

EXPERIMENTAL

The experimental group will have a joint aspiration performed at an initial visit (within the first 10 days after injury) and receive an injection of leukocyte poor platelet rich plasma injection in their knee. At a second visit 5-12 days after the initial visit, the patient will receive a joint aspiration and platelet rich plasma injection. A final joint aspiration will be performed at the time of surgery (within 4 weeks of injury).

Drug: Experimental Group

Interventions

Experimental Group DRUG

Patients will receive platelet rich plasma injection two times prior to surgery.

Also known as: Platelet Rich Plasma

Experimental Group

Control Group OTHER

Patients will have their knee aspirated at their initial physician visit and at the time of surgery.

Also known as: Aspiration Only

Control Group

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• No history of previous traumatic ipsilateral knee injury
• Bone bruise visualized on MRI
• No clinical evidence of posterior cruciate ligament injury with no more than grade 1 medial or lateral collateral ligament injury

You may not qualify if:

• Patients without a palpable knee effusion
• An injury occurring more than 10 days before enrollment
• Previous ipsilateral knee surgery
• Intra-articular cortisone or platelet rich plasma injection into either knee within 3 months of injury
• Participation in another clinical drug trial within the 4 weeks before injury
• A history of any inflammatory disease or immune-comprised

Sponsors & Collaborators

• Andrews Research & Education Foundation: lead

Study Sites (1)

Andrews Institute for Orthopaedics & Sports Medicine

Gulf Breeze, Florida, 32561, United States

Location

Related Publications (1)

• Anz AW, Branch EA, Jordan SE, Ostrander RV 3rd, Kindle BJ, Presley JC, Hackel JG, Maggi E, Plummer HA. Preoperative Platelet-Rich Plasma Injections Decrease Inflammatory and Chondrodegenerative Biomarkers in Patients With Acute Anterior Cruciate Ligament Tears: A Pilot Randomized Controlled Trial. Orthop J Sports Med. 2025 Mar 3;13(3):23259671241312754. doi: 10.1177/23259671241312754. eCollection 2025 Mar.

  PMID: 40052182 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Director of Research
• Organization: Andrews Research & Education Foundation

jessica.truett@andrewsref.org

8509168570

Study Officials

• Adam W Anz, MD

  Andrews Institute for Orthopaedics & Sports Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 12, 2019
• Study Start: September 12, 2019
• Primary Completion: September 1, 2022
• Study Completion: April 21, 2023
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)