A Randomized Controlled Trial for Patients Underwent Total Hip Arthroplasties Assisted by Surgical Navigation System

Not Applicable

• Conditions: Hip Arthropathy
• Interventions: Device: "VTS" surgical navigation system

• Registration Number: NCT04711720
• Lead Sponsor: Peking University Third Hospital

Brief Summary

This is a randomized controlled, multicenter study. According to the inclusion criteria, volunteers were recruited from patients undergoing total hip arthroplasty. After signing the informed consent, the subjects were assigned to the experimental group and the control group through the central randomization system. The researchers will complete the total hip arthroplasty for patients in the experimental group with the assistance of surgical navigation system. The patients in the control group do not use the surgical navigation system. The proportion of acetabular abduction angle and anteversion angle in the lewinnek safe area is the primary outcome measurement. The operation time, WOMAC score, Harris score, range of motion and dislocation rate are the secondaryoutcome measurements. The incidence of complications, devices and other adverse events were recorded.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-29
• Study Start: 2021-04
• Primary Completion: 2022-02
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Clinical diagnosis of primary hip osteoarthritis(OA), fracture of femoral neck (FFN),or secondary hip osteoarthritis due to developmental dysplasia of the hip (DDH), hip avascular necrosis (AVN), rheumatoid arthritis (RA), ankylosing spondylitis (AS), and coxa plana

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Exclusion Criteria

Severe vascular diseases of the lower extremity Neuromuscular diseases Infectious diseases Severe dysfunctions of major organs Severe neurosensory deficiencies caused by spinal diseases Unable to receive CT/MRI scans

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigation	"VTS" surgical navigation system	-

Primary Outcome Measures

Name	Time	Method
Acetabular location accuracy	Within 1 week after surgery	Proportion of abduction angle and anteversion angle of acetabular cup in lewinnek safe area

Secondary Outcome Measures

Name	Time	Method
Operation time	Immediately after surgery	Time from skin incision to wound closure
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	6 months after surgery	The WOMAC is a self administered questionnaire to assess joint function and quality of life for patients with osteoarthritis; it consists of 24 items: pain (5 items), stiffness (2 items), and physical function (17 items). The higher the total score, the worse the patient's pain, stiffness, and functional limitations. The WOMAC is validated for various languages, including Chinese
Harris Hip Score (HHS)	6 months after surgery	a rating scale with a maximum of 100 points, including the domains of pain, function, deformity, and motion