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

Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04088227
• Other study ID #: ACL-PRP Study
• Status: Recruiting
• Phase: Phase 2
• Start date: September 12, 2019
• Est. completion date: September 2023

Study information

• Verified date: August 2022
• Source: Andrews Research & Education Foundation
• Contact: Jessi L Truett, MA
• Phone: 850-916-8570
• Email: jessica.truett[@]andrewsref.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Anterior Cruciate Ligament Tear
• Rupture

Intervention

Drug:
• Experimental Group
Patients will receive platelet rich plasma injection two times prior to surgery.

Other:
• Control Group
Patients will have their knee aspirated at their initial physician visit and at the time of surgery.

Locations

Country	Name	City	State
United States	Andrews Institute for Orthopaedics & Sports Medicine	Gulf Breeze	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Andrews Research & Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)