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

Effect of Platelet Rich Plasma Injections on Inflammatory and Chondrodegenerative Biomarkers in Patients With Acute Anterior Cruciate Ligament Tears

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear
• Intervention / Treatment: Other: Control Group; Drug: Experimental Group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jessi L Truett, MA; Phone Number: 850-916-8570; Email: jessica.truett@andrewsref.org

Study Locations

• United States
  • Florida
    • Gulf Breeze, Florida, United States, 32561
      • Recruiting
      • Andrews Institute for Orthopaedics & Sports Medicine
      • Contact: Jessi Truett, MA; Phone Number: 850-916-8570; Email: jessica.truett@andrewsref.org
      • Principal Investigator: Adam Anz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Other: Control Group; Patients will have their knee aspirated at their initial physician visit and at the time of surgery.; Other Names: Aspiration Only
Experimental: 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).	Drug: Experimental Group; Patients will receive platelet rich plasma injection two times prior to surgery.; Other Names: Platelet Rich Plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Synovial Interleukin-1 Receptor Antagonist Concentration	The presence of this biomarker in the synovial fluid will be assessed.	Initial visit (within 10 days of injury), second visit (5-12 days after the initial visit), and at the time of surgery (within 4 weeks of injury)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in International Knee Documentation Committee Score	This survey assess knee function, symptoms, and sports activities. The scale scores range from 0-100 with a score of 100 indicating no functional limitations or symptoms.	Initial visit (within 10 days of injury), second visit (5-12 days after the initial visit), and at the time of surgery (within 4 weeks of injury)
Change in Knee Injury and Osteoarthritis Outcome Score	This survey assess knee pain and function. The scale scores range from 100 (no symptoms) to zero (extreme symptoms).	Initial visit (within 10 days of injury), second visit (5-12 days after the initial visit), and at the time of surgery (within 4 weeks of injury)

Collaborators and Investigators

• Sponsor: Andrews Research & Education Foundation
• Investigators: Principal Investigator: Adam W Anz, MD, Andrews Institute for Orthopaedics & Sports Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2019
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Rupture; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: ACL-PRP Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No