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.
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.
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.
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.
Cohort
Other
High tibial osteotomy
Other interventionCorrection of lower limb malalignement with tibial bone wedge insertion/removal
Lysholm Knee Score
It is a validated measurement scale that assesses knee functionality through 8 items, which help determine the condition of the knee in response to the functional demands of daily activities. This evaluation form is commonly used to assess the outcomes of surgery in patients who have undergone operations for ligament or meniscal injuries of the knee. The final score is obtained by summing the various scores from the different items and ranges from 0 to 100. The scores are divided into subgroups: Excellent (95-100); Good (84-94); Fair (65-83); Poor (\<64).
International Knee Documentation Committee (IKDC)
The IKDC form is a subjective knee evaluation module that reflects the limitations on activities an individual can perform in daily life and sports, as well as the presence or absence of symptoms. There are three main domains of the IKDC evaluation form: Symptoms, which include pain, stiffness, swelling, and a sense of locking; Sports and daily activities; Current knee function and function before the injury. The questionnaire consists of 10 questions: seven items investigate the patient's symptoms, one item addresses sports participation, one item-comprising 9 points-concerns the difficulties the patient experiences in performing daily activities, and the last item measures the current functionality of the knee. The score ranges from 0 to 100, with 100 representing the absence of limitations and symptoms; the further away from this score, the worse the result. The scores can be divided into four groups: excellent (80-100), good (60-80), fair (30-60), and poor (0-30).
Objective IKDC(IKDC standard evaluation form)
It represents a clinical form completed by the physician following a thorough objective examination of the knee, during which various clinical tests are performed to evaluate potential joint deformities, objective instability, and meniscal injuries. The obtained score determines an objective evaluation grade codified using Roman letters. According to this scale, grade "A" is assigned to a knee with "normal, healthy" functionality, grade "B" is assigned to a knee with "nearly normal" functionality, grade "C" is assigned to a knee with "moderately abnormal" functionality, and grade "D" is assigned to a knee with "severely abnormal" functionality.
VAS (visual analog scale)
It is a unidimensional quantitative numeric pain rating scale with 10 points. The scale requires the patient to select the number that best describes the intensity of their pain, from 0 to 10, at that specific moment. 0 means no pain and 10 indicates the worst possible pain.
SF-36 (Short Form-36 Health Survey)
It is the most well-known and widely used health-related quality of life measurement tool in international literature. It assesses various health concepts through 36 multiple-choice questions, with the data aggregated into 8 scales that investigate: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Additionally, there is one question about changes in health status over the past year.
Click on the lead sponsor to view all of their trials.
