Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04101864
• Other study ID #: 77/05/12
• Status: Completed
• Phase: N/A
• Start date: May 4, 2017
• Est. completion date: February 2, 2018

Study information

• Verified date: September 2019
• Source: Valdoltra Orthopedic Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 2, 2018
• Est. primary completion date: February 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Procedure:
• Electromagnetic navigation
Acetabular component placement in total hip arthroplasty will be performed wit the help of electromagnetic image-less navigation system.
• Freehand
In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique.

Locations

Country	Name	City	State
Slovenia	Valdoltra Orthopedic Hospital	Ankaran

Sponsors (1)

Lead Sponsor	Collaborator
Valdoltra Orthopedic Hospital

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetabular component position	Comparison of the precision and the accuracy of acetabular components between both groups	Up to 48 hours after surgery
Secondary	Surgical time	Comparison of duration of surgery between both groups	Immediately after surgical procedure
Secondary	Clinical result	Comparison of improvement of Harris hip score between both groups	8-10 weeks postoperatively