Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears
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|ClinicalTrials.gov Identifier: NCT04088227|
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : October 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Tear Anterior Cruciate Ligament Rupture||Drug: Experimental Group Other: Control Group||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Platelet Rich Plasma Injections on Inflammatory and Chondrodegenerative Biomarkers in Patients With Acute Anterior Cruciate Ligament Tears|
|Actual Study Start Date :||September 12, 2019|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2023|
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 Name: 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 Name: Platelet Rich Plasma
- Change in Synovial Interleukin-1 Receptor Antagonist Concentration [ Time Frame: 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) ]The presence of this biomarker in the synovial fluid will be assessed.
- Change in International Knee Documentation Committee Score [ Time Frame: 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) ]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.
- Change in Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 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) ]This survey assess knee pain and function. The scale scores range from 100 (no symptoms) to zero (extreme symptoms).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088227
|Contact: Hillary A Plummer, PhDemail@example.com|
|United States, Florida|
|Andrews Institute for Orthopaedics & Sports Medicine||Recruiting|
|Gulf Breeze, Florida, United States, 32561|
|Contact: Hillary Plummer, PhD 850-916-8796 firstname.lastname@example.org|
|Principal Investigator: Adam Anz, MD|
|Principal Investigator:||Adam W Anz, MD||Andrews Institute for Orthopaedics & Sports Medicine|