Clinical trial NCT06462040: Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee Joint
Official title: Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee Joint
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteochondral Defect
Osteochondritis Dissecans
Osteochondral Fracture
Osteochondral Fracture of Patella
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from all subjects who have already undergone surgical treatment for fixation of knee osteochondral fragments using resorbable screws since 2017, and all new patients eligible for this type of intervention until 2025 at the Orthopedic and Traumatology Clinic II of the Rizzoli Orthopedic Institute.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients aged between 12 and 35 years at the time of the surgical intervention.
3. Patients with the presence of osteochondral fragments confirmed by magnetic resonance imaging.
4. Patients with osteochondral lesions observed on imaging and symptoms attributable to the presence of osteochondral fragments.
5. Patients diagnosed with osteochondritis dissecans or recent contusion/sprain trauma.

Exclusion Criteria:

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

Primary outcomes:
measure: KOOS (Knee Injury and Ostearthritis Outcome Score) score
timeFrame: At least 24 months after surgery
Secondary outcomes:
measure: Kujala Anterior Knee Pain Scale
timeFrame: At least 24 months after surgery
measure: International Knee Documentation Committee (IKDC) Score
timeFrame: At least 24 months after surgery
measure: Objective IKDC (IKDC standard evaluation form)
timeFrame: At least 24 months after surgery
measure: MARX Activity Rating Scale
timeFrame: At least 24 months after surgery
measure: VAS (Visual Analog Scale) for pain
timeFrame: At least 24 months after surgery
measure: Radiological evaluation (MRI, magnetic resonance imaging) throughout ICRS Cartilage Score
timeFrame: 24 months after surgery
measure: Radiological evaluation (MRI, magnetic resonance imaging) throughout Outerbridge Classification
timeFrame: 24 months after surgery
measure: Sports Activity Level, Tegner Score
timeFrame: At least 24 months after surgery
measure: Thigh circumference
timeFrame: At least 24 months after surgery
measure: Anterior knee pain / pain during knee flexion
timeFrame: At least 24 months after surgery
measure: Likert scale
timeFrame: At least 24 months after surgery
measure: Complications, subsequent interventions, or surgical failures
timeFrame: At least 24 months after surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Rizzoli Orthopedic Institute
Study officials:
References: