The Efficiency and Safety of PRP Treatment After Anterior Cruciate Ligament Reconstruction.

May 29, 2024 updated by: Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz

The Efficiency and Safety of Platelet-rich Plasma Intra-articular Injections After Anterior Cruciate Ligament Reconstruction: MRI and Clinical Outcome Analysis.

The anterior cruciate ligament (ACL) is the main stabilizer of the knee joint, as it controls anteroposterior and rotatory knee laxity. The number of ACL injuries has increased in the past three decades because more and more people participate in recreational and competitive sporting activities. Injury to the ACL often leads to functional instability, damage to the meniscus and articular cartilage, and an increased risk for osteoarthritis (OA). Emphasizes the fact that ACL has limited healing potential 'The gold standard' treatment is ACL reconstruction, with over 200,000 reconstruction surgeries performed annually in the United States. However, despite the success of surgery in restoring functional stability, it has been found so far in several studies that the prevalence of moderate to severe arthritis in long-term radiographic follow-up is more than 50% after ACL reconstruction within 5 to 15 years or sooner. ACL-injured knees had at least 3 times higher risk of arthritis than uninjured contralateral knees. Early osteoarthritis was observed on magnetic resonance imaging (MRI) up to 11 years following ACL injury after operative and nonoperative management. Because ACL injuries predominantly occur in individuals between the ages of 15 and 25 years, symptoms of OA most often affect patients during their most productive years. This is worrisome because most patients who sustain ACL tears are free of the risk of other factors for developing OA.Consequently, posttraumatic OA after ACL reconstruction ultimately translates into a large economic effect on the healthcare system owing to the young age of this population. Platelet-rich plasma is an autologous solution of highly concentrated platelets dispersed in a small capacity of plasma. Enthusiasm for the therapeutic potential of platelets is based on its rich omplement of anabolic growth factors and anti-inflammatory cytokines in the platelets, which induce cellular proliferation, migration, differentiation, angiogenesis, and extracellular matrix synthesis. In addition, the functional mechanisms of PRP in OA treatment have been explained by its effect on modulating critical pro-inflammatory mediators and catabolic enzymes, as well as maintaining joint homeostasis. The reasons for this early incidence of post-traumatic OA remain unclear, but the underlying mechanisms have been speculated to involve some combination of cartilage damage at the time of injury, and posttraumatic molecular changes in the joint, including immune reactions or persistent secondary inflammation. We hypothesized that PRP injection after ACL reconstruction could prevent cartilage damage, act anti-inflammatory, and provide better clinical and radiological outcomes seen in MRI.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Toruń, Poland, 87-100
        • Recruiting
        • Dawid Szwedowski
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dawid Szwedowski, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • subject is 18-45 years old
  • subject has BMI < 40 kg/m2
  • subject had ACL reconstrution
  • small asymptomatic meniscal lesions that won't require repair
  • subject must be willing to abstain from other intra-articular treatments of the knee for the duration of the study.
  • subject is willing to discontinue all analgesics including nonsteroidal anti-inflammatory drugs (NSAIDs), except tramadol and paracetamol, at least one month before the synovial fluid aspiration and through the completion of the study
  • subject is able to understand and comply with the requirements of the study and voluntarily provides consent

Exclusion Criteria:

  • subject has a history of metabolic diseases, endocrine disorders, rheumatic and connective tissue diseases, cancer, hormonal contraception, steroid therapy, antibiotic therapy
  • subject had an intraarticular injection into the affected joint
  • subject had previous operations (beside ACL reconstruction) or fractures of the affected limb
  • subject has a history of nicotine, alcohol, or drug addiction
  • subject has a meniscal tear that requires suturing or total meniscectomy seen on MRI
  • subject has multi-ligament knee injuries or multi-organ injury
  • subject has significant varus or valgus deformity greater than 10 degrees in either knee, determined by an X-ray

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platelet-rich Plasma
Biological: Platelet-rich plasma
Platelet-rich plasma intra-articular injection in patients after anterior cruciate ligament reconstruction
Active Comparator: Hyaluronic Acid
Biological: Platelet-rich plasma
Platelet-rich plasma intra-articular injection in patients after anterior cruciate ligament reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain and cartilage volume
Time Frame: 12 months
The 2 primary outcomes were 12-month change in overall average knee pain scores (11-point scale; range, 0-10, with higher scores indicating worse pain; minimum clinically important difference of 1.8) and percentage change in cartilage volume as assessed by magnetic resonance imaging (MRI).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Synovitis
Time Frame: 6 and 12 months post-treatment
The assesment of synovial fluid volume and fat pad synovitis seen in ultrasonography and MRI
6 and 12 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

April 15, 2028

Study Completion (Estimated)

April 15, 2030

Study Registration Dates

First Submitted

May 29, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Estimated)

June 4, 2024

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NicolausCopernicusU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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