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

NCT ID: NCT04088227

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-12
• Study Completion Date: 2023-04-21

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.

Detailed Description

A non-surgical treatment option for the management of osteoarthritis include injectables such as corticosteroids and platelet rich plasma. These injectables work by positively affecting cartilage cells, also known as chondrocytes, and the cells of the joint lining tissue, also known as synoviocytes. Platelet rich plasma is an autologous derived blood product, i.e. a joint injectable made from the patient's own blood at the time and location of injection with simple blood centrifugation. Studies in the bench-top laboratory setting have provided in-vitro evidence that platelet rich plasma decreases synoviocyte production of metallometal proteases, an inflammatory protein with negative effects on cartilage and decreases the effects of inflammatory proteins.

Conditions

Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Group

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).

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

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

Experimental Group

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).

Group Type: EXPERIMENTAL

Experimental Group

Intervention Type: DRUG

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

Interventions

Experimental Group

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

Intervention Type: DRUG

Control Group

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

Intervention Type: OTHER

Other Intervention Names

Platelet Rich Plasma; Aspiration Only

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andrews Research & Education Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam W Anz, MD

Role: PRINCIPAL_INVESTIGATOR

Andrews Institute for Orthopaedics & Sports Medicine

Locations

Andrews Institute for Orthopaedics & Sports Medicine

Gulf Breeze, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40052182 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ACL-PRP Study

Identifier Type: -

Identifier Source: org_study_id