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Early Radiographic and Clinical Outcomes of Robotic-Arm-Assisted Versus Conventional TKA

NCT05987839 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-08-14

No results posted yet for this study

Summary

Purpose: A robotic system was recently introduced to improve prosthetic alignment during total knee arthroplasty (TKA). The purpose of this multicenter prospective randomized controlled trial (RCT) study was to determine whether robotic-arm-assisted TKA improves the clinical and radiological outcomes in patients compared to conventional TKA.

Methods: One hundred and thirty patients who underwent primary TKA were enrolled in this prospective, multicenter RCT conducted in 3 hospitals. Five patients were lost to follow-up at 6 weeks after surgery. Therefore, 125 patients (63 in the intervention group and 62 in the control group) remained in the final analysis. The primary outcome was the rate of patients whose mechanical axis of the femur was less than 3° deviated from the mechanical axis of the tibia evaluated by full-length weight-bearing X-rays of the lower limb at 6 weeks postoperatively. Secondary outcomes will include operation times, 6-week postoperative functional outcomes evaluated by the American Knee Society Score (KSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), SF-36, adverse events (AEs) and serious adverse events (SAEs).

Hypothesis: Robotic-arm-assisted TKA is safe and effective as demonstrated in this trial.

Conditions

  • Total Knee Arthroplasty
  • Robotic

Interventions

PROCEDURE

robotic system

Total knee arthroplasty assisted by knee navigation and positioning system

Sponsors & Collaborators

  • Qianfoshan Hospital

    collaborator OTHER

  • Chifeng Municipal Hospital

    collaborator OTHER

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Zheng Yuhang, MD · Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-05-15
Completion
2023-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05987839 on ClinicalTrials.gov