Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hip Osteoarthritis

Intervention / Treatment
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* Procedure: Electromagnetic navigation
* Procedure: Freehand


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Sample size will be calculated. The Consolidated Standards of Reporting Trials statement guidelines will be followed to perform this prospective, randomized, controlled, trial and to present the results. Included patients will be randomly allocated in a 1:1 ratio into the study and the control group. Randomization will be conducted using computer-generated numbers.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetabular component position | 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 | Comparison of duration of surgery between both groups | Immediately after surgical procedure | 
| Clinical result | Comparison of improvement of Harris hip score between both groups | 8-10 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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navigation, hip arthroplasty, surgical time, landmark