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NCT Number: NCT04088227

Effects of Platelet Rich Plasma Injections on Biomarkers After 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.

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Key information

Age range

14 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Andrews Institute for Orthopaedics & Sports Medicine

Gulf Breeze, Florida, 32561, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental Group

Drug

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

Other names: Platelet Rich Plasma

Control Group

Other

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

Other names: Aspiration Only

Primary outcomes

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

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

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

Sponsors and collaborators

Lead sponsor

Andrews Research & Education Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Sep 12, 2019
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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