Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty

September 22, 2019 updated by: Valdoltra Orthopedic Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ankaran, Slovenia, 6280
        • Valdoltra Orthopedic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Electromagnetic navigation
Acetabular component placement in total hip arthroplasty will be performed wit the help of electromagnetic image-less navigation system.
Active Comparator: Freehand
In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique.
Procedure: Freehand
In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acetabular component position
Time Frame: Up to 48 hours after surgery
Comparison of the precision and the accuracy of acetabular components between both groups
Up to 48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical time
Time Frame: Immediately after surgical procedure
Comparison of duration of surgery between both groups
Immediately after surgical procedure
Clinical result
Time Frame: 8-10 weeks postoperatively
Comparison of improvement of Harris hip score between both groups
8-10 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valdoltra Orthopedic Hospital

Investigators

  • Principal Investigator: Rene Mihalič, MD, Valdoltra Orthopedic Hospital
  • Study Director: Rihard Trebše, MD, PhD, Valdoltra Orthopedic Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2017

Primary Completion (Actual)

February 2, 2018

Study Completion (Actual)

February 2, 2018

Study Registration Dates

First Submitted

September 9, 2019

First Submitted That Met QC Criteria

September 22, 2019

First Posted (Actual)

September 24, 2019

Study Record Updates

Last Update Posted (Actual)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 22, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 77/05/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No data will be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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