Personalized robotic knee surgery for osteoarthritis

Personalized Approach to Robotic Total Knee Arthroplasty

This study is testing a new personalized robotic knee surgery for people with severe osteoarthritis to see if it helps them feel better and recover more effectively than traditional methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 21 Years to 90 Years
• Sex: All
• Sponsor: I.M. Sechenov First Moscow State Medical University (other)
• Locations: 1 site (Moscow)
• Trial ID: NCT05750784 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to implement a personalized preoperative planning system for robotic total knee arthroplasty, focusing on kinematic alignment to improve surgical outcomes. The study will involve 150 patients with stage 3-4 knee osteoarthritis, comparing results from personalized robotic techniques against traditional mechanical alignment methods. It will assess the effectiveness of this approach in restoring joint function and reducing patient dissatisfaction post-surgery. The methodology includes both retrospective and prospective evaluations to develop a comprehensive protocol for personalized knee arthroplasty.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 90 with stage 3-4 knee osteoarthritis and significant knee pain.

Not a fit: Patients who refuse surgical treatment or have severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved surgical outcomes and higher patient satisfaction in knee arthroplasty procedures.

How similar studies have performed: While robotic knee arthroplasty has been explored, this personalized approach using kinematic alignment is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Availability of written informed consent of the patient to participate in the study;
2. Patients with stage 3-4 osteoarthritis of the knee joint (according to Kellgren-Lawrence).
3. Men and women from 21 to 90 years old.
4. Pain in the knee joint above 3 points according to VAS
5. Opportunity for observations during the entire study period (12 months);
6. Mental adequacy, ability, willingness to cooperate and to fulfill the doctor's recommendations.

Exclusion Criteria:

1. Refusal of the patient from surgical treatment;
2. Presence of contraindications to surgical treatment;
3. Severe forms of diabetes mellitus (glycosylated hemoglobin\> 9%);
4. Diseases of the blood (thrombopenia, thrombocytopenia, anemia with Hb \<90 g / l);
5. The patient's unwillingness to conscious cooperation.
6. Refusal of the patient to participate in the study;
7. Non-compliance with the hospital regimen, according to the order of the Ministry of Health and Social Development of Russia dated 01.08.07, No. 514;
8. The impossibility of observing the patient within the control period after the operation.

Where this trial is running

Moscow

• University clinical hospital №1 I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery — Moscow, Russian Federation (RECRUITING)

Study contacts

• Study coordinator: Alexey Lychagin

Conditions: Knee Osteoarthritis, total knee arthroplasty, robotic total knee arthroplasty, the active robotic surgical system, kinematic alignment, mechanical alignment