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

Primary Purpose

Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Rupture

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Experimental Group
Control Group
Sponsored by
Andrews Research & Education Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anterior Cruciate Ligament Tear

Eligibility Criteria

14 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Andrews Institute for Orthopaedics & Sports MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Change in Synovial Interleukin-1 Receptor Antagonist Concentration
The presence of this biomarker in the synovial fluid will be assessed.

Secondary Outcome Measures

Change in International Knee Documentation Committee Score
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
This survey assess knee pain and function. The scale scores range from 100 (no symptoms) to zero (extreme symptoms).

Full Information

First Posted
September 11, 2019
Last Updated
August 4, 2022
Sponsor
Andrews Research & Education Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04088227
Brief Title
Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears
Official Title
Effect of Platelet Rich Plasma Injections on Inflammatory and Chondrodegenerative Biomarkers in Patients With Acute Anterior Cruciate Ligament Tears
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Andrews Research & Education Foundation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Rupture

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Experimental Group
Other Intervention Name(s)
Platelet Rich Plasma
Intervention Description
Patients will receive platelet rich plasma injection two times prior to surgery.
Intervention Type
Other
Intervention Name(s)
Control Group
Other Intervention Name(s)
Aspiration Only
Intervention Description
Patients will have their knee aspirated at their initial physician visit and at the time of surgery.
Primary Outcome Measure Information:
Title
Change in Synovial Interleukin-1 Receptor Antagonist Concentration
Description
The presence of this biomarker in the synovial fluid will be assessed.
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)
Secondary Outcome Measure Information:
Title
Change in International Knee Documentation Committee Score
Description
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.
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)
Title
Change in Knee Injury and Osteoarthritis Outcome Score
Description
This survey assess knee pain and function. The scale scores range from 100 (no symptoms) to zero (extreme symptoms).
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessi L Truett, MA
Phone
850-916-8570
Email
jessica.truett@andrewsref.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam W Anz, MD
Organizational Affiliation
Andrews Institute for Orthopaedics & Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andrews Institute for Orthopaedics & Sports Medicine
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessi Truett, MA
Phone
850-916-8570
Email
jessica.truett@andrewsref.org
First Name & Middle Initial & Last Name & Degree
Adam Anz, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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