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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Tear Anterior Cruciate Ligament Rupture Drug: Experimental Group Other: Control Group Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088227


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

Locations
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United States, Florida
Andrews Institute for Orthopaedics & Sports Medicine Recruiting
Gulf Breeze, Florida, United States, 32561
Contact: Hillary Plummer, PhD    850-916-8796    hillary.plummer@andrewsref.org   
Principal Investigator: Adam Anz, MD         
Sponsors and Collaborators
Andrews Research & Education Foundation
Investigators
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Principal Investigator: Adam W Anz, MD Andrews Institute for Orthopaedics & Sports Medicine

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Responsible Party: Andrews Research & Education Foundation
ClinicalTrials.gov Identifier: NCT04088227     History of Changes
Other Study ID Numbers: ACL-PRP Study
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries