Clinical and Radiological Results of Long Term Tibial and Femoral Osteotomy in Knee Ostheoarthritis With Concomitant Lower Limb Malalignement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High tibial osteotomy.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis, Malalignment, Bone. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-term Clinical and Radiographic Outcomes of Different Knee Osteotomy Techniques for the Treatment of Compartmental Knee Osteoarthritis With Lower Limb Malalignment.
Overview
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.
Interventions
- Other High tibial osteotomy
Correction of lower limb malalignement with tibial bone wedge insertion/removal
Primary outcome measures
- Lysholm Knee Score [Time frame: 24 months after surgery]
Secondary outcome measures (10)
- International Knee Documentation Committee (IKDC) [Time frame: 24 months after surgery]
- Objective IKDC(IKDC standard evaluation form) [Time frame: 24 months after surgery]
- VAS (visual analog scale) [Time frame: 24 months after surgery]
- SF-36 (Short Form-36 Health Survey) [Time frame: 24 months after surgery]
- Tegner Score [Time frame: 24 months after surgery]
- Hip circonference [Time frame: 24 months after surgery]
- Anterior knee pain / pain during knee flexion [Time frame: 24 months after surgery]
- Patient satisfaction [Time frame: 24 months after surgery]
- Radiographic evaluation [Time frame: 24 months after surgery]
- Complications or subsequent interventions [Time frame: 24 months after surgery]
Eligibility criteria
Inclusion criteria
- Patients undergoing corrective knee osteotomy and any associated procedures such as meniscal repair/resection/replacement, ligament reconstruction, chondral treatment, or regenerative infiltrative treatment;
- Patients aged between 18 and 70 years at the time of surgical intervention;
- Patients with isolated compartmental osteoarthritis;
- Patients with a varus or valgus knee alignment defect of at least 3° compared to mechanical neutrality.
Exclusion criteria
- Patients with advanced multicompartimental osteoarthritis;
- Patients who are no longer reachable;
- Women of childbearing age who cannot exclude pregnancy;
- Patients unable to give informed consent or patients unwilling to sign the informed consent form.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Istituto Ortopedico Rizzoli — Bologna
Identifiers
NCT: NCT06462625 · KNEE OSTEOTOMY-OA