Early Clinical and Radiological Outcomes of a Novel Robotic TKA System

NCT ID: NCT06638047

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-08
• Study Completion Date: 2024-05-13

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).

Conditions

Total Knee Anthroplasty; Robotic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RA TKA

Robotic-assisted TKA

Group Type: EXPERIMENTAL

robotic-assisted TKA

Intervention Type: PROCEDURE

Robotic-assisted TKA means that TKA surgery is operated with the guidance of robotic system.

CI TKA

TKA with conventional instruments

Group Type: ACTIVE_COMPARATOR

CI-TKA

Intervention Type: PROCEDURE

TKA operated with conventional instruments

Interventions

robotic-assisted TKA

Robotic-assisted TKA means that TKA surgery is operated with the guidance of robotic system.

Intervention Type: PROCEDURE

CI-TKA

TKA operated with conventional instruments

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tian Hua

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

JUST-RA-TKA

Identifier Type: -

Identifier Source: org_study_id