Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-04

Study Completion Date

2018-02-02

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.

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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.

Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Postoperative computed tomography measurements of acetabular component position will be done by independent technician.

Study Groups

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Freehand

In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique.

Group Type ACTIVE_COMPARATOR

Freehand

Intervention Type PROCEDURE

In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique.

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.

Group Type EXPERIMENTAL

Electromagnetic navigation

Intervention Type PROCEDURE

Acetabular component placement in total hip arthroplasty will be performed wit the help of electromagnetic image-less navigation system.

Interventions

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Electromagnetic navigation

Acetabular component placement in total hip arthroplasty will be performed wit the help of electromagnetic image-less navigation system.

Intervention Type PROCEDURE

Freehand

In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique.

Intervention Type PROCEDURE

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