Early Clinical and Radiological Outcomes of a Novel Robotic TKA System (NCT06638047) | Clinical Trial Compass
CompletedNot Applicable
Early Clinical and Radiological Outcomes of a Novel Robotic TKA System
China144 participantsStarted 2022-09-08
Plain-language summary
This study aimed to evaluate the early clinical and radiological outcomes of robot assisted total knee arthroplasty, and to determine the efficiency and safety of its bone resection and implant positioning of the novel robot system.
144 patients undergoing primary TKA were enrolled in this prospective, multicenter RCT conducted in 3 hospitals. The primary outcome was the rate of patients whose postoperative alignment was less than 3° deviated from the planned evaluated by full-length weight-bearing X-rays of the lower limb at 12 weeks postoperatively. Secondary outcomes will include coronal and sagittal alignment of the components, operation times, blood loss, 12-week range of motion(ROM), 12-week postoperative functional outcomes and satisfaction evaluated by the American Knee Society Score (KSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and adverse events (AEs).
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18-85 years (including 18 and 85), regardless of gender;
* Patients scheduled for unilateral primary total knee arthroplasty based on the clinical judgment of the study physician;
* The subject or their guardian has been informed of the study, agrees to all terms of the trial, signs an informed consent form approved by the ethics committee, and agrees to participate in the trial.
Exclusion Criteria:
* The side scheduled for surgery has significant hip joint disease, such as substantial bone defects or severe limitations in joint mobility;
* Patients with active infections around the knee joint or systemic infections;
* Discontinuity or severe functional loss of the knee extensor mechanism, painless knee joint fusion, Charcot joint, poor surgical tolerance, or other conditions that may adversely affect surgical prognosis;
* Patients with contraindications for traditional TKA surgery;
* Pregnant or breastfeeding women;
* Patients known to have excessive alcohol consumption or substance abuse; Body mass index (BMI) \> 35 kg/m²;
* Patients who have participated in other clinical trials within one month prior to signing the informed consent form;
* Patients with mental or intellectual disabilities that may affect clinical outcome evaluations;
* Patients deemed unsuitable for participation in this clinical trial by the investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.