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

NCT ID: NCT04711720

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Hip Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Navigation

Group Type EXPERIMENTAL

"VTS" surgical navigation system

Intervention Type DEVICE

The"VTS" surgical navigation system can accurately match the preoperative and intraoperative image data with the patient's anatomical structure on the operating table, track the surgical instruments during the operation, and update the position of the surgical instruments on the patient's image in real time, so that the doctor can clearly understand the position of the surgical instruments relative to the patient's anatomical structure, and make the operation procedure more accurate and safer.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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"VTS" surgical navigation system

The"VTS" surgical navigation system can accurately match the preoperative and intraoperative image data with the patient's anatomical structure on the operating table, track the surgical instruments during the operation, and update the position of the surgical instruments on the patient's image in real time, so that the doctor can clearly understand the position of the surgical instruments relative to the patient's anatomical structure, and make the operation procedure more accurate and safer.

Intervention Type DEVICE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role collaborator

Chifeng Municipal Hospital

OTHER

Sponsor Role collaborator

Jining Medical University

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Huan Tian, MD PhD

Role: CONTACT

Phone: +8613511065187

Email: [email protected]

Xiao Geng, MD

Role: CONTACT

Phone: +8618811332096

Email: [email protected]

Other Identifiers

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VTSTH

Identifier Type: -

Identifier Source: org_study_id