NCT06251752 Long Term Evaluation of Clinical and Radiologic Results on Femoro-patellar Joint After High Tibial Osteotomy
| NCT ID | NCT06251752 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-10-22 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2020-10-22 with a primary completion date of 2026-12.
⚠ 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
Osteotomies are among the oldest orthopedic treatments, in use for over 2000 years and still commonly employed. The basic principle involves making a bone cut to allow the realignment of the limb segment affected by deformity. Today, new knowledge and technologies, understanding of bone healing mechanisms, and the introduction of new fixation methods have made osteotomies one of the preferred treatments for early knee arthritis. They serve as an alternative to joint prosthesis implantation in young patients with medium to high functional demand. Medial knee osteoarthritis is a pathology increasingly prevalent in today's population. The resulting varus deformity leads to a shift in the load axis on the medial tibial plateau. Osteotomy in this context becomes a therapeutic tool capable of restoring the correct mechanical axis of the lower limb and delaying or avoiding the progression of arthritis, thus avoiding the need for joint replacement. The two most commonly used techniques are the Closing Wedge Lateral High Tibial Osteotomy (LCW-HTO) and the Opening Wedge Medial High Tibial Osteotomy (MOW-HTO), which are high tibial osteotomies in closure with a wedge removal and in opening with a wedge insertion, respectively. The medium to long-term effects of this procedure, in terms of survival and modification of the tibial slope, have been extensively studied, as evidenced by the extensive literature on the subject. However, the effect of this intervention, in its two variants, on the progression of femoro-patellar arthritis and the height of the patella remains poorly investigated to date.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06251752 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 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 NCT06251752 currently recruiting?
Yes, NCT06251752 is actively recruiting participants. Contact the research team at giuliomaria.marcheggianimuccioli@ior.it for enrollment information.
Where is the NCT06251752 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06251752 clinical trial?
NCT06251752 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 50 participants.