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

Knee Osteoarthritis Clinical Trial

— KNEE OSTEOTOMY  

Official title:

Long-term Clinical and Radiographic Outcomes of Different Knee Osteotomy Techniques for the Treatment of Compartmental Knee Osteoarthritis With Lower Limb Malalignment.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06462625
• Other study ID #: KNEE OSTEOTOMY-OA
• Status: Active, not recruiting
• Start date: January 12, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Malalignment
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• High tibial osteotomy
Correction of lower limb malalignement with tibial bone wedge insertion/removal

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	24 months after surgery
Secondary	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).	24 months after surgery
Secondary	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.	24 months after surgery
Secondary	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.	24 months after surgery
Secondary	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.	24 months after surgery
Secondary	Tegner Score	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.	24 months after surgery
Secondary	Hip circonference	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.	24 months after surgery
Secondary	Anterior knee pain / pain during knee flexion	To specifically assess the symptoms of the femoropatellar joint, patients will be asked to answer these questions in a dichotomous manner (YES/NO).	24 months after surgery
Secondary	Patient satisfaction	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.	24 months after surgery
Secondary	Radiographic evaluation	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.	24 months after surgery
Secondary	Complications or subsequent interventions	Any complications and subsequent interventions will be documented and recorded in the Case Report Form (CRF).	24 months after surgery