Early Clinical and Radiological Outcomes of a Novel Robotic TKA System

Peking University Third Hospital144 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

144

Conditions

Total Knee Anthroplasty Robotic Surgery

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 12 weeks post-surgery

Secondary Outcomes

FFC angle

frontal femoral component (FFC) angle

Time frame: 12 weeks post-surgery

outliers of FFC angle

outliers of frontal femoral component (FFC) angle (\>3 degree)

Time frame: 12 weeks post-surgery

FTC angle

frontal tibia component (FTC) angle

Time frame: 12 weeks post-surgery

outliers of FTC angle

outliers of frontal tibia component (FTC) angle (\>3 degree)

Time frame: 12 weeks post-surgery

LFC angle

lateral femoral component (LFC) angle

Time frame: 12 weeks post-surgery

outliers of LFC angle

outliers of lateral femoral component (LFC) angle (\>3 degree)

Time frame: 12 weeks post-surgery

LTC angle

lateral tibia component (LTC) angle

Time frame: 12 weeks post-surgery

outliers of LTC angle

outliers of lateral tibia component (LTC) angle (\>3 degree)

Time frame: 12 weeks post-surgery

Surgical duration

In this study, surgical duration is defined as the time from the first incision to the completion of skin closure

Time frame: During operation

Blood loss

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).

Time frame: 3 days after surgery

ROM

ROM refers to the maximum passive range of knee motion

Time frame: 12 weeks post-surgery

Knee Society Score (KSS)

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.

Time frame: screening and 12 weeks post-surgery.

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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.

Time frame: screening and 12 weeks post-surgery.

Incidence of adverse events and serious adverse events

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.

Time frame: Through study completion, an average of 12 weeks

Early Clinical and Radiological Outcomes of a Novel Robotic TKA System

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes