Evaluating outcomes of knee joint surgeries using resorbable screws for osteochondral injuries
Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee Joint
This study is testing if using special screws that dissolve can help teenagers and young adults recover better from knee surgeries for cartilage injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 12 Years to 35 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06462040 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical and radiological outcomes of patients who undergo surgical fixation of osteochondral fragments in the knee using resorbable screws. It focuses on adolescents and young adults, a demographic that has been underrepresented in existing literature. The study aims to gather medium to long-term follow-up data on the effects of these injuries and the effectiveness of the fixation technique. By analyzing outcomes from patients treated since 2017, the study seeks to establish a clearer understanding of the best practices for managing osteochondral injuries.
Who should consider this trial
Good fit: Ideal candidates are patients aged 12 to 35 years with confirmed osteochondral fragments requiring surgical fixation.
Not a fit: Patients with complex ligamentous injuries or fractures at the time of intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for knee injuries in young patients, potentially reducing chronic pain and the risk of early osteoarthritis.
How similar studies have performed: While there is limited literature on this specific approach, similar studies have shown promise in treating osteochondral injuries with various fixation techniques.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bologna, Bologna
- IRCCS Rizzoli Orthopedic Institute — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Stefano Zaffagnini
- Email: stefano.zaffagnini@ior.it
- Phone: 0516366075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.