NCT06462625 Clinical and Radiological Results of Long Term Tibial and Femoral Osteotomy in Knee Ostheoarthritis With Concomitant Lower Limb Malalignement
| NCT ID | NCT06462625 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Knee Osteoarthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-01-12 |
| Primary Completion | 2024-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2023-01-12 with a primary completion date of 2024-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The present study aims to evaluate the long-term and medium-term outcomes of different knee osteotomy techniques in the treatment of knee osteoarthritis in patients with lower limb malalignment. This evaluation is necessary in the current context of research on the treatment and prevention of knee osteoarthritis through treatments that do not involve or allow for the postponement of prosthetic replacement. Among the biological treatments performed in orthopedic clinical practice, osteotomy is one of the most promising. However, further long-term evaluations are needed to more clearly determine the indications and potential of this type of intervention, considering the various surgical procedures described for performing it.
Eligibility Criteria
Inclusion Criteria: 1. Patients undergoing corrective knee osteotomy and any associated procedures such as meniscal repair/resection/replacement, ligament reconstruction, chondral treatment, or regenerative infiltrative treatment; 2. Patients aged between 18 and 70 years at the time of surgical intervention; 3. Patients with isolated compartmental osteoarthritis; 4. Patients with a varus or valgus knee alignment defect of at least 3° compared to mechanical neutrality. Exclusion Criteria: 1. Patients with advanced multicompartimental osteoarthritis; 2. Patients who are no longer reachable; 3. Women of childbearing age who cannot exclude pregnancy; 4. Patients unable to give informed consent or patients unwilling to sign the informed consent form.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06462625 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06462625 currently recruiting?
Yes, NCT06462625 is actively recruiting participants. Contact the research team at stefano.zaffagnini@ior.it for enrollment information.
Where is the NCT06462625 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06462625 clinical trial?
NCT06462625 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 150 participants.