Gulf Breeze, Florida 32561

  • Anterior Cruciate Ligament Rupture

Purpose:

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 summary:

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.


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


NCT ID:

NCT04088227


Primary Contact:

Principal Investigator
Adam W Anz, MD
Andrews Institute for Orthopaedics & Sports Medicine

Hillary A Plummer, PhD
Phone: 850-916-8796
Email: hillary.plummer@andrewsref.org


Backup Contact:

N/A


Location Contact:

Gulf Breeze, Florida 32561
United States

Hillary Plummer, PhD
Phone: 850-916-8796
Email: hillary.plummer@andrewsref.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.