Skip to main content
Clinical Trials/NCT04101864
NCT04101864
Completed
Not Applicable

Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty: A Prospective Randomized Study

Valdoltra Orthopedic Hospital1 site in 1 country84 target enrollmentMay 4, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Osteoarthritis
Sponsor
Valdoltra Orthopedic Hospital
Enrollment
84
Locations
1
Primary Endpoint
Acetabular component position
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

A prospective randomized study comparing accuracy and precision of acetabular component placement in total hip arthroplasty with use of novel electromagnetic navigation system versus freehand technique.

Detailed Description

Patients with hip arthritis, who are to be treated with total hip arthroplasty will be randomized in two groups. Patents allocated to study group will get their acetabular components implanted with the help of electromagnetic navigation system. Patients allocated to the control group will get their acetabular components implanted with freehand technique. Accuracy and precision of implanted acetabular components will be assessed on images obtained by postoperative computed tomography. Postoperative inclination and anteversion angles of acetabular components will be measured by the independent technician. Results will be statistically analyzed and compared.

Registry
clinicaltrials.gov
Start Date
May 4, 2017
End Date
February 2, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Valdoltra Orthopedic Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age above 18 years
  • unilateral surgery
  • osteoarthritis of the hip
  • no previous surgery on the affected hip
  • implantation of the same acetabular component through the same approach
  • signed informed consent

Exclusion Criteria

  • age under 18 years
  • unwilling to participate
  • prior surgery on affected hip

Outcomes

Primary Outcomes

Acetabular component position

Time Frame: Up to 48 hours after surgery

Comparison of the precision and the accuracy of acetabular components between both groups

Secondary Outcomes

  • Surgical time(Immediately after surgical procedure)
  • Clinical result(8-10 weeks postoperatively)

Study Sites (1)

Loading locations...

Similar Trials