Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
NCT06442319

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

Led by Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz · Updated on 2024-06-04

60

Participants Needed

1

Research Sites

306 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 45 years
  • Body mass index (BMI) less than 40 kg/m2
  • Have had anterior cruciate ligament (ACL) reconstruction
  • Small asymptomatic meniscal lesions that do not require repair
  • Willing to avoid other knee intra-articular treatments during the study
  • Willing to stop all pain medications except tramadol and paracetamol at least one month before synovial fluid sampling and during the study
  • Able to understand and follow study requirements and give voluntary consent
Not Eligible

You will not qualify if you...

  • History of metabolic diseases, endocrine disorders, rheumatic or connective tissue diseases, cancer, hormonal contraception, steroid therapy, or antibiotic therapy
  • Previous intra-articular injection in the affected knee
  • Previous surgeries (other than ACL reconstruction) or fractures on the affected leg
  • History of nicotine, alcohol, or drug addiction
  • Meniscal tear requiring suturing or total meniscectomy seen on MRI
  • Multi-ligament knee injuries or injuries to multiple organs
  • Significant knee deformity (varus or valgus) greater than 10 degrees on X-ray

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dawid Szwedowski

Torun, Poland, 87-100

Actively Recruiting

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Research Team

D

Dawid Szwedowski, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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