Improving knee surgery with robotic systems
Optimization of Total Knee Arthroplasty Using Robotic Systems
NA · I.M. Sechenov First Moscow State Medical University · NCT05712291
This study is testing if using advanced robotic systems during knee surgery can help people with knee osteoarthritis recover better and have more accurate results compared to traditional methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (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 | NCT05712291 on ClinicalTrials.gov |
What this trial studies
This study aims to optimize total knee arthroplasty (TKA) using advanced robotic systems to enhance surgical outcomes for patients with knee osteoarthritis. It will develop algorithms for preoperative planning and surgical intervention, focusing on patients with varying degrees of bone density and osteophytes. The study will include both retrospective and prospective observations of 250 patients, assessing the effectiveness of robotic-assisted techniques compared to traditional methods. By leveraging robotic technology, the study seeks to reduce variability in surgical procedures and improve the accuracy of prosthesis alignment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 90 with stage 3-4 knee osteoarthritis and significant pain.
Not a fit: Patients with severe comorbidities or those unwilling to undergo surgical treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and quality of life for patients undergoing knee arthroplasty.
How similar studies have performed: Other studies have shown promising results with robotic-assisted surgeries, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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, PhD
- Email: clinic@travma.moscow
- Phone: 89166389545
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Knee Osteoarthritis, total knee arthroplasty, robotic total knee arthroplasty, the active robotic surgical system, robotic system in orthopedic