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

Phase 2
Completed
Conditions
Anterior Cruciate Ligament Rupture
Anterior Cruciate Ligament Tear
Interventions
Other: Control Group
Drug: Experimental Group
Registration Number
NCT04088227
Lead Sponsor
Andrews Research & Education Foundation
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control GroupControl GroupThe 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).
Experimental GroupExperimental GroupThe 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).
Primary Outcome Measures
NameTimeMethod
Change in Synovial Interleukin (IL) -1 Receptor Antagonist ConcentrationTimepoint 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Andrews Institute for Orthopaedics & Sports Medicine

🇺🇸

Gulf Breeze, Florida, United States

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