The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction
Launched by ISTITUTO ORTOPEDICO RIZZOLI · Nov 28, 2019
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a specific surgical treatment for patients who have torn their anterior cruciate ligament (ACL) and also have damage to the cartilage in their knee. The goal is to compare the outcomes of two different surgical approaches: one that includes a technique called nanofractures and one that does not. Researchers want to see how effective these methods are in helping patients recover both clinically (how they feel and function) and through imaging (pictures of the knee).
To participate in this trial, individuals need to be between 18 and 55 years old and have a complete ACL injury along with significant cartilage damage that is confirmed during surgery. Participants should be generally healthy and able to provide consent. Throughout the trial, participants will receive regular follow-ups to monitor their progress. It's important to note that certain health conditions, such as severe diabetes or previous knee surgeries, may prevent someone from being eligible for the study. Overall, this trial aims to improve treatment options for people facing these common knee injuries.
Gender
ALL
Eligibility 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.
About Istituto Ortopedico Rizzoli
Istituto Ortopedico Rizzoli is a renowned orthopedic research and treatment institute based in Bologna, Italy, dedicated to advancing musculoskeletal health through innovative clinical trials and cutting-edge medical practices. With a strong emphasis on research, the institute collaborates with leading experts in orthopedics, rehabilitation, and related fields to develop and evaluate new therapies and surgical techniques. Committed to improving patient outcomes, Istituto Ortopedico Rizzoli not only focuses on high-quality clinical care but also fosters a robust research environment that supports the translation of scientific findings into clinical applications.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bologna, , Italy
Bologna, , Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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