Evaluating long-term outcomes of knee osteotomy for osteoarthritis
Long-term Clinical and Radiographic Outcomes of Different Knee Osteotomy Techniques for the Treatment of Compartmental Knee Osteoarthritis With Lower Limb Malalignment.
This study is testing different knee surgery techniques to see how well they help people with knee osteoarthritis and leg alignment issues over the long term.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06462625 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term and medium-term outcomes of various knee osteotomy techniques in treating knee osteoarthritis in patients with lower limb malalignment. It focuses on patients undergoing corrective knee osteotomy and associated procedures, aiming to provide insights into the effectiveness of these interventions. The study is observational and seeks to gather data on the biological treatments that can potentially delay or prevent the need for prosthetic replacement. The findings will help clarify the indications and potential of knee osteotomy as a treatment option.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 70 with isolated compartmental osteoarthritis and a knee alignment defect of at least 3°.
Not a fit: Patients with advanced multicompartimental osteoarthritis or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into non-prosthetic treatment options for knee osteoarthritis, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promising results with knee osteotomy techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bologna
- IRCCS Istituto Ortopedico Rizzoli — 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.