Clinical and Radiological Results of Long Term Tibial and Femoral Osteotomy in Knee Ostheoarthritis With Concomitant Lower Limb Malalignement

Recruiting

• Conditions: Malalignment, Bone; Knee Osteoarthritis
• Interventions: Other: High tibial osteotomy

• Registration Number: NCT06462625
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-12
• Primary Completion: 2024-06-01
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-12
• Study First Posted: 2024-06-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Closing wedge	High tibial osteotomy	Patients undergoing closing wedge high tibial osteotomy in knee ostheoarthritis and lower limb malalignement
Opening wedge	High tibial osteotomy	Patients undergoing opening wedge high tibial osteotomy in knee ostheoarthritis and lower limb malalignement

Primary Outcome Measures

Name	Time	Method
Lysholm Knee Score	24 months after surgery	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).

Secondary Outcome Measures

Name	Time	Method
Complications or subsequent interventions	24 months after surgery	Any complications and subsequent interventions will be documented and recorded in the Case Report Form (CRF).
Objective IKDC(IKDC standard evaluation form)	24 months after surgery	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.
Hip circonference	24 months after surgery	Measuring the thigh circumference at 5 cm and 15 cm above the superior pole of the patella allows for the assessment of muscle trophism in the subjects under examination, thereby evaluating the potential influence of the technique used on the knee's extensor apparatus.
Patient satisfaction	24 months after surgery	In order to assess the level of patient satisfaction, they will be asked to respond to the question "Are you satisfied with the surgical intervention?" Once again, the response will be dichotomous.
Tegner Score	24 months after surgery	It allows for the estimation of a subject's level of physical activity with a score ranging from 0 to 10, where 0 represents 'incapacity' and 10 represents 'participation in competitive sports, such as national or international level soccer.' This score is the most commonly used to define the level of physical activity in patients with knee disorders. Additionally, the patient will be asked how many years they have been active in sports and whether the reason for reducing or ceasing activity is related to knee pathology or not.
SF-36 (Short Form-36 Health Survey)	24 months after surgery	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.
International Knee Documentation Committee (IKDC)	24 months after surgery	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).
VAS (visual analog scale)	24 months after surgery	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.
Anterior knee pain / pain during knee flexion	24 months after surgery	To specifically assess the symptoms of the femoropatellar joint, patients will be asked to answer these questions in a dichotomous manner (YES/NO).
Radiographic evaluation	24 months after surgery	The study will collect clinical and imaging data from patients to assess the development of osteoarthritis and other radiographic anomalies. If patients lack radiological documentation according to the study protocol post-intervention, weight-bearing lower limb X-rays and lateral projection X-rays of the operated knee will be conducted to evaluate osteoarthritis severity using the Kellgren-Lawrence scale. This scale categorizes osteoarthritis into 5 grades based on joint space reduction and osteophyte presence. Additionally, computer-assisted quantitative analyses will be performed on radiographic images at the collaborating facility for precise measurement of pre- and post-operative joint angles.

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy