Clinical trial NCT06462625: Clinical and Radiological Results of Long Term Tibial and Femoral Osteotomy in Knee Ostheoarthritis With Concomitant Lower Limb Malalignement
Official title: Long-term Clinical and Radiographic Outcomes of Different Knee Osteotomy Techniques for the Treatment of Compartmental Knee Osteoarthritis With Lower Limb Malalignment.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Osteoarthritis
Malalignment, Bone
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Based on the number of patients treated at Rizzoli with this type of surgical intervention and considering a 25% dropout rate, it is estimated that 150 patients with a follow-up period of 2 to 20 years can be included in the study. It is noteworthy that previous studies with similar aims have a patient sample similar to that proposed by the current study.

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.

Primary outcomes:
measure: Lysholm Knee Score
timeFrame: 24 months after surgery
Secondary outcomes:
measure: International Knee Documentation Committee (IKDC)
timeFrame: 24 months after surgery
measure: Objective IKDC(IKDC standard evaluation form)
timeFrame: 24 months after surgery
measure: VAS (visual analog scale)
timeFrame: 24 months after surgery
measure: SF-36 (Short Form-36 Health Survey)
timeFrame: 24 months after surgery
measure: Tegner Score
timeFrame: 24 months after surgery
measure: Hip circonference
timeFrame: 24 months after surgery
measure: Anterior knee pain / pain during knee flexion
timeFrame: 24 months after surgery
measure: Patient satisfaction
timeFrame: 24 months after surgery
measure: Radiographic evaluation
timeFrame: 24 months after surgery
measure: Complications or subsequent interventions
timeFrame: 24 months after surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
References: