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Recruiting NCT06462040

Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee Joint

— Observational Osteochondral Defect Osteochondritis Dissecans Osteochondral Fracture Osteochondral Fracture of Patella

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fixation of osteochdral fragments with reabsorbable screws.
Who it may be relevant to
Registry conditions: Osteochondral Defect, Osteochondritis Dissecans, Osteochondral Fracture, Osteochondral Fracture of Patella. Basic parameters: 12 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Various techniques for the fixation of unstable osteochondral fragments have been used over the years, each with associated advantages and disadvantages, and differing clinical outcomes. However, the literature on the treatment of this type of injury in the adolescent and young adult population is scarce and involves small case series. Failure to treat these injuries can lead to serious consequences such as chronic pain, residual joint stiffness, and the development of early osteoarthritis, necessitating more invasive and burdensome interventions for the national health system, such as prosthetic replacements or osteotomies. Due to the lack of real consensus within the scientific community regarding the ideal treatment for these patients and the insufficient medium/long-term follow-up data on the effects of these injuries on articular cartilage in young patients, this study aims to evaluate the clinical and radiological conditions of patients undergoing osteochondral fragment fixation using the same surgical technique (fixation with resorbable screws performed arthroscopically or via open surgery depending on the lesion's location) in order to clarify preventive measures against cartilage degeneration following these injuries, which are very common in adolescence.

Interventions

  • Procedure Fixation of osteochdral fragments with reabsorbable screws
    Arthroscopic or mini-open fixation of free-intrarticular or unstable osteochondral fragments due to osteochondritis dissecans or osteochondral fractures with reabsorbable screws

Primary outcome measures

  • KOOS (Knee Injury and Ostearthritis Outcome Score) score [Time frame: At least 24 months after surgery]
Secondary outcome measures (12)
  • Kujala Anterior Knee Pain Scale [Time frame: At least 24 months after surgery]
  • International Knee Documentation Committee (IKDC) Score [Time frame: At least 24 months after surgery]
  • Objective IKDC (IKDC standard evaluation form) [Time frame: At least 24 months after surgery]
  • MARX Activity Rating Scale [Time frame: At least 24 months after surgery]
  • VAS (Visual Analog Scale) for pain [Time frame: At least 24 months after surgery]
  • Radiological evaluation (MRI, magnetic resonance imaging) throughout ICRS Cartilage Score [Time frame: 24 months after surgery]
  • Radiological evaluation (MRI, magnetic resonance imaging) throughout Outerbridge Classification [Time frame: 24 months after surgery]
  • Sports Activity Level, Tegner Score [Time frame: At least 24 months after surgery]
  • Thigh circumference [Time frame: At least 24 months after surgery]
  • Anterior knee pain / pain during knee flexion [Time frame: At least 24 months after surgery]
  • Likert scale [Time frame: At least 24 months after surgery]
  • Complications, subsequent interventions, or surgical failures [Time frame: At least 24 months after surgery]

Eligibility criteria

Inclusion criteria

  • Patients undergoing surgical fixation of osteochondral fragment using resorbable screw technique, either arthroscopically or via mini-open procedure depending on the lesion's location, from 01/01/2017, and all new patients eligible for this type of intervention until 31/12/2025.
  • Patients aged between 12 and 35 years at the time of the surgical intervention.
  • Patients with the presence of osteochondral fragments confirmed by magnetic resonance imaging.
  • Patients with osteochondral lesions observed on imaging and symptoms attributable to the presence of osteochondral fragments.
  • Patients diagnosed with osteochondritis dissecans or recent contusion/sprain trauma.

Exclusion criteria

  • Patients with concomitant complex ligamentous injuries or fractures at the time of the intervention;
  • Patients who are no longer reachable;
  • Women of childbearing age who cannot exclude pregnancy;
  • Patients who are unable to provide informed consent or patients who are unwilling to sign the informed consent form.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Rizzoli Orthopedic Institute — Bologna

Identifiers

NCT: NCT06462040 · OC-FIX

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗