Clinical trial NCT06638047: Early Clinical and Radiological Outcomes of a Novel Robotic TKA System
Official title: Early Clinical and Radiological Outcomes of a Novel Robotic TKA System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Anthroplasty
Robotic Surgery
Keywords: total knee arthroplasty
robot
radiological
clinical outcome
postoperative alignment
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: HKA outliers
timeFrame: 12 weeks post-surgery
Secondary outcomes:
measure: FFC angle
timeFrame: 12 weeks post-surgery
measure: outliers of FFC angle
timeFrame: 12 weeks post-surgery
measure: FTC angle
timeFrame: 12 weeks post-surgery
measure: outliers of FTC angle
timeFrame: 12 weeks post-surgery
measure: LFC angle
timeFrame: 12 weeks post-surgery
measure: outliers of LFC angle
timeFrame: 12 weeks post-surgery
measure: LTC angle
timeFrame: 12 weeks post-surgery
measure: outliers of LTC angle
timeFrame: 12 weeks post-surgery
measure: Surgical duration
timeFrame: During operation
measure: Blood loss
timeFrame: 3 days after surgery
measure: ROM
timeFrame: 12 weeks post-surgery
measure: Knee Society Score (KSS)
timeFrame: screening and 12 weeks post-surgery.
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: screening and 12 weeks post-surgery.
measure: Incidence of adverse events and serious adverse events
timeFrame: Through study completion, an average of 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: