Early Clinical and Radiological Outcomes of a Novel Robotic TKA System

NCT06638047 | Completed DMC

• 1 other identifier: JUST-RA-TKA
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Keywords

total knee arthroplasty; robot; radiological; clinical outcome; postoperative alignment

Outcome Measures

Primary Outcomes (1)

• HKA outliers

  the proportion of patients with a deviation of ≤ 3° between the mechanical axis (hip-knee-ankle angle, or HKA angle) measured from a full-length, frontal-view lower limb X-ray

  12 weeks post-surgery

Secondary Outcomes (14)

• FFC angle

  12 weeks post-surgery

• outliers of FFC angle

  12 weeks post-surgery

• FTC angle

  12 weeks post-surgery

• outliers of FTC angle

  12 weeks post-surgery

• LFC angle

  12 weeks post-surgery

Study Arms (2)

RA TKA

EXPERIMENTAL

Robotic-assisted TKA

Procedure: robotic-assisted TKA

CI TKA

ACTIVE COMPARATOR

TKA with conventional instruments

Procedure: CI-TKA

Interventions

robotic-assisted TKA PROCEDURE

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

RA TKA

CI-TKA PROCEDURE

TKA operated with conventional instruments

CI TKA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 15, 2024
• Study Start: September 8, 2022
• Primary Completion: February 2, 2023
• Study Completion: May 13, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)