Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty

Not Applicable

Completed

• Conditions: Hip Osteoarthritis
• Interventions: Procedure: Electromagnetic navigation; Procedure: Freehand

• Registration Number: NCT04101864
• Lead Sponsor: Valdoltra Orthopedic Hospital

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.

Study Timeline

• Study Start: 2017-05-04
• Primary Completion: 2018-02-02
• Study Completion: 2018-02-02
• Status Verified: 2019-09
• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-22
• Last Update Submitted: 2019-09-22
• Study First Posted: 2019-09-24
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electromagnetic navigation	Electromagnetic navigation	In the study group acetabular components in total hip arthroplasty will be placed with the help of electromagnetic image-less navigation system. Reference plane will be anterior pelvic plane.
Freehand	Freehand	In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique.

Primary Outcome Measures

Name	Time	Method
Acetabular component position	Up to 48 hours after surgery	Comparison of the precision and the accuracy of acetabular components between both groups

Secondary Outcome Measures

Name	Time	Method
Surgical time	Immediately after surgical procedure	Comparison of duration of surgery between both groups
Clinical result	8-10 weeks postoperatively	Comparison of improvement of Harris hip score between both groups

Trial Locations

Locations (1)

Valdoltra Orthopedic Hospital; 🇸🇮 Ankaran, Slovenia