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

NCT06462040 | Recruiting

• 1 other identifier: OC-FIX
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteochondral Fracture; Osteochondral Fracture of Patella; Osteochondral Defect; Osteochondritis Dissecans

Outcome Measures

Primary Outcomes (1)

• KOOS (Knee Injury and Ostearthritis Outcome Score) score

  It represents a subjective score composed of 42 questions divided into 5 main domains. These domains investigate various aspects of symptoms and daily activities as well as the quality of life related to the knee and are divided as follows: * Symptoms, composed of 7 questions, 2 of which pertain to stiffness; * Pain, composed of 9 questions; * Functions and daily activities, composed of 17 questions; * Sports and recreational activities, composed of 5 questions; * Quality of life in relation to the knee, composed of 4 questions. All questions use the same response format, utilizing a quantitative scale ranging from 0 (no issues) to 4 (severe difficulty). Scores are calculated separately for each domain and converted into a percentage score, where 100 represents excellent physical condition with no symptoms and 0 represents severe disability with limitations in daily activities and constant symptoms even at rest.

  At least 24 months after surgery

Secondary Outcomes (12)

• Kujala Anterior Knee Pain Scale

  At least 24 months after surgery

• International Knee Documentation Committee (IKDC) Score

  At least 24 months after surgery

• Objective IKDC (IKDC standard evaluation form)

  At least 24 months after surgery

• MARX Activity Rating Scale

  At least 24 months after surgery

• VAS (Visual Analog Scale) for pain

  At least 24 months after surgery

Interventions

Fixation of osteochdral fragments with reabsorbable screws PROCEDURE

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

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Rizzoli Orthopedic Institute

Bologna, Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Osteochondritis Dissecans

Condition Hierarchy (Ancestors)

Osteochondritis; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Stefano Zaffagnini

CONTACT

0516366075; stefano.zaffagnini@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Medicine and Surgery, University of Bologna

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: September 25, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IT (1)