Treatment for knee ligament and cartilage injuries
Randomized Study on the Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction
This study tests whether treating cartilage injuries during ACL surgery helps people recover better compared to those who only have the ACL surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT04184687 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical and radiological outcomes in patients undergoing anterior cruciate ligament (ACL) reconstruction who also have cartilaginous lesions. It compares the results of patients treated with nanofractures for their cartilage injuries against those who do not receive treatment for these lesions. The goal is to clarify the therapeutic indications for treating cartilaginous lesions in conjunction with ACL reconstruction. The study aims to provide more reliable treatment guidelines for these common knee injuries.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 55 with complete ACL injuries and significant cartilaginous lesions.
Not a fit: Patients with less severe cartilage lesions, those with other significant health issues, or those who have had recent knee surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients with ACL injuries and associated cartilage damage, potentially enhancing recovery outcomes.
How similar studies have performed: While the treatment of ACL injuries is well-studied, the specific combination of ACL reconstruction with nanofractures for cartilage lesions is less common, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female patients, 18 \< age \< 55; 2. Patients with complete ACL injury candidates for surgical reconstruction of the same; 3. Cartilaginous lesion of the femur-tibial compartment of grade III-IV ICRS ≤3 cm2 confirmed intra-operatively; 4. Patients without evidence of osteoarthritis 5. Patients' ability and consent to participate in clinical and radiological follow-up; 6. Signature of informed consent. Exclusion Criteria: 1. Patients incapable of understanding and of wanting; 2. State of immunodepression; 3. Patients with malignant neoplasms; 4. Patients suffering from rheumatic diseases; 5. Patients suffering from non-compensated diabetes; 6. Patients suffering from uncompensated thyroid metabolic disorders; 7. Patients abusing alcoholic beverages, drugs or drugs; 8. Patients with axial deviations\> 5 °; 9. Body Mass Index\> 35; 10. Patients treated with surgery at the same knee in the previous 12 months. 11. Cartilaginous lesions grade I-II according to the ICRS score. 12. Cartilage lesions with a diameter greater than 3 cm². 13. Non-suturable meniscal lesions requiring meniscectomy\> 50% and patients with previous meniscectomies\> 50% in the same compartment. 14. Need for further associated surgical procedures in addition to the reconstruction of ACL and possibly the nanofractures.
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Alessandro Di Martino
- Email: alessandro.dimartino@ior.it
- Phone: 0516366567
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.