Evaluating long-term results of knee realignment surgery
Long Term Evaluation of Clinical and Radiologic Results on Femoro-patellar Joint After High Tibial Osteotomy
NA · Istituto Ortopedico Rizzoli · NCT06251752
This study is testing if knee realignment surgery can help younger people with arthritis feel better and avoid needing a joint replacement for a longer time.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06251752 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term clinical and radiologic outcomes of high tibial osteotomy in patients with medial unicompartmental knee osteoarthritis. The procedure aims to realign the knee joint to restore proper load distribution and potentially delay the progression of arthritis. Participants will undergo follow-up assessments over a period exceeding 60 months, focusing on both clinical evaluations and X-ray imaging to monitor changes in the femoro-patellar joint. The study seeks to provide insights into the effectiveness of osteotomy as an alternative to joint replacement in younger patients with high functional demands.
Who should consider this trial
Good fit: Ideal candidates are individuals under 65 years old diagnosed with medial unicompartmental knee osteoarthritis who have undergone previous valgus osteotomy procedures.
Not a fit: Patients with prior injuries to the lower limb, severe arthritis, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a viable alternative to joint replacement for younger patients suffering from knee osteoarthritis.
How similar studies have performed: Previous studies have shown that high tibial osteotomy can be effective in managing knee osteoarthritis, suggesting a promising approach in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of medial unicompartmental knee osteoarthritis (Outerbridge III-IV) 2. Follow-up \> 60 months 3. Completeness of clinical and radiographic documentation. 4. Previous valgus osteotomy procedure (MOW-HTO or LCW-HTO) 5. Age \<65 years Exclusion Criteria: 1. Patients with previous injuries affecting the involved lower limb. 2. Patients with prior traumatic, septic, and rheumatoid arthritis. 3. Patients with previous alterations of the patellofemoral joint. 4. Patients with knee ligament injuries. 5. Patients with confirmed neuromuscular disorders or psychomotor disturbances. 6. Patients with congenital generalized hypermobility syndrome. 7. Patients with severe pathologies in other organs or systems limiting activities of daily living (ADL). 8. Patients who refuse to participate in the study.
Where this trial is running
Bologna
- IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (RECRUITING)
Study contacts
- Study coordinator: Giulio Maria Marcheggiani Muccioli, MD PhD
- Email: giuliomaria.marcheggianimuccioli@ior.it
- Phone: 051 636
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.
Conditions: Knee Osteoarthritis, Deformity Knee, knee osteotomy, high tibial osteotomy