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

Hip Arthropathy Clinical Trial

Official title:

A Randomized Controlled, Multicenter Study for Patients Underwent Total Hip Arthroplasties Assisted by "VTS"Surgical Navigation System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04711720
• Other study ID #: VTSTH
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: December 2022

Study information

• Verified date: January 2021
• Source: Peking University Third Hospital
• Contact: Huan Tian, MD PhD
• Phone: +8613511065187
• Email: tianhua[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: December 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Intervention

Device:
• "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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Peking University Third Hospital	Chifeng Municipal Hospital, Jining Medical University, Qianfoshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetabular location accuracy	Proportion of abduction angle and anteversion angle of acetabular cup in lewinnek safe area	Within 1 week after surgery
Secondary	Operation time	Time from skin incision to wound closure	Immediately after surgery
Secondary	the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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	6 months after surgery
Secondary	Harris Hip Score (HHS)	a rating scale with a maximum of 100 points, including the domains of pain, function, deformity, and motion	6 months after surgery