Early Clinical and Radiological Outcomes of a Novel Robotic TKA System

Not Applicable

Completed

• Conditions: Total Knee Anthroplasty; Robotic Surgery

• Registration Number: NCT06638047
• Lead Sponsor: Peking University Third Hospital

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-09-08
• Primary Completion: 2023-02-02
• Study Completion: 2024-05-13
• Status Verified: 2024-10
• Study First Submitted: 2024-10-06
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HKA outliers	12 weeks post-surgery	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

Secondary Outcome Measures

Name	Time	Method
outliers of FTC angle	12 weeks post-surgery	outliers of frontal tibia component (FTC) angle (\>3 degree)
LFC angle	12 weeks post-surgery	lateral femoral component (LFC) angle
outliers of LFC angle	12 weeks post-surgery	outliers of lateral femoral component (LFC) angle (\>3 degree)
LTC angle	12 weeks post-surgery	lateral tibia component (LTC) angle
outliers of LTC angle	12 weeks post-surgery	outliers of lateral tibia component (LTC) angle (\>3 degree)
Surgical duration	During operation	In this study, surgical duration is defined as the time from the first incision to the completion of skin closure
Blood loss	3 days after surgery	Postoperative blood loss is calculated using the Gross formula in this study. The Gross equation was used to calculate the total blood loss (mL) as preoperative blood volume×(preoperative HCT level-postoperative HCT level).
ROM	12 weeks post-surgery	ROM refers to the maximum passive range of knee motion
outliers of FFC angle	12 weeks post-surgery	outliers of frontal femoral component (FFC) angle (\>3 degree)
FTC angle	12 weeks post-surgery	frontal tibia component (FTC) angle
Incidence of adverse events and serious adverse events	Through study completion, an average of 12 weeks	Throughout the study, any adverse events that occurred were recorded, and the corresponding incidence was calculated.; Similarly, any serious adverse events that occurred during the study were recorded, and the corresponding incidence was calculated.
FFC angle	12 weeks post-surgery	frontal femoral component (FFC) angle
Knee Society Score (KSS)	screening and 12 weeks post-surgery.	The KSS, developed by the American Knee Society, evaluates objective knee indicators, symptoms, patient satisfaction, patient expectations, and functional activities. A total score above 85 is considered excellent, 70-84 is good, 60-69 is fair, and below 60 is poor.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	screening and 12 weeks post-surgery.	The WOMAC measures knee function in terms of pain, stiffness, and physical function across 25 items. Pain is assessed with five items, stiffness with two items, and physical function with 18 items. Each item is scored from 0 to 4, with higher scores indicating more severe symptoms.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China