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

NCT04711720 | Unknown

• 1 other identifier: VTSTH
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Arthropathy

Outcome Measures

Primary Outcomes (1)

• Acetabular location accuracy

  Proportion of abduction angle and anteversion angle of acetabular cup in lewinnek safe area

  Within 1 week after surgery

Secondary Outcomes (3)

• Operation time

  Immediately after surgery

• the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  6 months after surgery

• Harris Hip Score (HHS)

  6 months after surgery

Study Arms (2)

Navigation

EXPERIMENTAL

Device: "VTS" surgical navigation system

Control

NO INTERVENTION

Interventions

"VTS" surgical navigation system 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.

Navigation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Qianfoshan Hospital: collaborator
• Chifeng Municipal Hospital: collaborator
• Jining Medical University: collaborator

Central Study Contacts

Huan Tian, MD PhD

CONTACT

+8613511065187; tianhua@bjmu.edu.cn

Xiao Geng, MD

CONTACT

+8618811332096; gengxiao@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: April 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share