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RecruitingNCT06442319Updated Jun 4, 2024

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

An interventional study of Platelet-rich plasma in ACL Injury, Knee Osteoarthritis and Knee Injuries, sponsored by Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz. Recruiting at 1 site in Poland. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-06-04.

Sponsored by Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • ACL Injury
  • Knee Osteoarthritis
  • Knee Injuries

Keywords

  • PRP, ACL reconstruction, knee osteoarthritis
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In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

This is the only study on the registry with Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Platelet-rich Plasma

    Biological: Platelet-rich plasma

  • Active comparator
    Hyaluronic Acid

    Biological: Platelet-rich plasma

Interventions

  • BiologicalPlatelet-rich plasma

    Platelet-rich plasma intra-articular injection in patients after anterior cruciate ligament reconstruction

06

What researchers measure

Primary outcomes

  1. Pain and cartilage volume

    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).

    Time frame: 12 months

Secondary outcomes

  1. Synovitis

    The assesment of synovial fluid volume and fat pad synovitis seen in ultrasonography and MRI

    Time frame: 6 and 12 months post-treatment

07

Study locations

1 of 1 sites recruiting
  • Dawid Szwedowski
    Toruń, 87-100, Poland
    Recruiting
08

References and documents

Publications

  • Lohmander LS, Ostenberg A, Englund M, Roos H. High prevalence of knee osteoarthritis, pain, and functional limitations in female soccer players twelve years after anterior cruciate ligament injury. Arthritis Rheum. 2004 Oct;50(10):3145-52. doi: 10.1002/art.20589. PubMed 15476248 ↗
  • Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797. Erratum In: N Engl J Med. 2010 Aug 26;363(9):893. PubMed 20660401 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06442319
Lead sponsor
Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz
Responsible party
Sponsor
First posted
Jun 4, 2024
Start date
Jun 1, 2024 (estimated)
Primary completion
Apr 15, 2028 (estimated)
Completion
Apr 15, 2030 (estimated)
Last update
Jun 4, 2024

Study contacts

Dawid Szwedowski, MD, PhD
Contact
dszwedow@yahoo.com
608075237

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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