Robotic knee replacement tailored for varus (bow-legged) knees
Official title: Total Knee Arthroplasty in Varus Deformity
Run by I.M. Sechenov First Moscow State Medical University · NCT07465484 · Data updated 2026-11-12
This study will test whether using weight-bearing CT scans and robotic surgery to tailor alignment improves outcomes for adults with one-sided varus knee osteoarthritis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | I.M. Sechenov First Moscow State Medical University Academic / other |
| Locations | 1 site (Moscow) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | March 12, 2026 |
| Trial ID | NCT07465484 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with unilateral grade 3–4 knee osteoarthritis, varus deformity (>3° or HKA <177°), BMI under 35, ASA score ≤III, able to consent and complete 12 months of follow-up are ideal candidates.
✕Probably not a fit
People with severe ligament instability or major bone defects, prior knee reconstructions, impaired weight-bearing of the opposite leg, metal implants in the lower extremities, or very high BMI (>40) are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants with unilateral, advanced varus knee osteoarthritis will receive total knee arthroplasty performed with an active robotic surgical system, with alignment decisions informed by multislice CT and weight-bearing (vertical) CT comparisons to the opposite limb. The study will quantify physiological versus pathological varus under load and use those measurements to guide mechanical or kinematic alignment choices. Investigators will develop an algorithm for selecting alignment strategy based on the degree of varus deformity and follow patients for 12 months after surgery. Outcomes will focus on limb alignment, pain, and functional recovery.
Why it matters
Potential benefit: If successful, patients could get more precise alignment during knee replacement, potentially improving pain relief and implant function.
How similar studies have gone: Robotic total knee arthroplasty and kinematic versus mechanical alignment approaches have shown promising but mixed results in prior studies, while using weight-bearing CT to define physiological varus is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients over 18 years of age with grade 3-4 knee osteoarthritis (according to Kellgren-Lawrence) and pain score of 5 or higher on a 10-point VAS scale. 2. Varus deformity of the lower limb (HKA angle \<177°, or varus \>3°) 3. Anesthesia risk according to the ASA scale of no more than III. 4. BMI less than 35 kg/m2. 5. Patient must be monitored throughout the entire study period (12 months). 6. Patient must be mentally competent and compliant. 7. Patient must provide written informed consent to participate in the study. Exclusion Criteria: 1. Body mass index \> 40 kg/m². 2. Instability of the collateral ligaments of the knee joint requiring the installation of ligamentous systems, presence of primary severe bone defects. 3. Impaired weight-bearing ability of the contralateral limb. 4. Presence of metal implants or foreign bodies in the lower extremities. 5. Previous knee interventions, such as reconstruction of the knee ligament apparatus, or corrective osteotomies of the femur and tibia. 6. Patient refusal to participate in the study. 7. Patient failure to comply with the recommendations of the treating physician or the prescribed regimen.
Where it's running
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University clinical hospital №1 I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery
Moscow, Russia Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.