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Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Electromagnetic navigation
Freehand
Sponsored by
Valdoltra Orthopedic Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring navigation, hip arthroplasty, surgical time, landmark

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Valdoltra Orthopedic Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electromagnetic navigation

Freehand

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Acetabular component position
Comparison of the precision and the accuracy of acetabular components between both groups

Secondary Outcome Measures

Surgical time
Comparison of duration of surgery between both groups
Clinical result
Comparison of improvement of Harris hip score between both groups

Full Information

First Posted
September 9, 2019
Last Updated
September 22, 2019
Sponsor
Valdoltra Orthopedic Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04101864
Brief Title
Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty
Official Title
Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
February 2, 2018 (Actual)
Study Completion Date
February 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valdoltra Orthopedic Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
navigation, hip arthroplasty, surgical time, landmark

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Postoperative computed tomography measurements of acetabular component position will be done by independent technician.
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electromagnetic navigation
Arm Type
Experimental
Arm Description
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.
Arm Title
Freehand
Arm Type
Active Comparator
Arm Description
In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique.
Intervention Type
Procedure
Intervention Name(s)
Electromagnetic navigation
Intervention Description
Acetabular component placement in total hip arthroplasty will be performed wit the help of electromagnetic image-less navigation system.
Intervention Type
Procedure
Intervention Name(s)
Freehand
Intervention Description
In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique.
Primary Outcome Measure Information:
Title
Acetabular component position
Description
Comparison of the precision and the accuracy of acetabular components between both groups
Time Frame
Up to 48 hours after surgery
Secondary Outcome Measure Information:
Title
Surgical time
Description
Comparison of duration of surgery between both groups
Time Frame
Immediately after surgical procedure
Title
Clinical result
Description
Comparison of improvement of Harris hip score between both groups
Time Frame
8-10 weeks postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rene Mihalič, MD
Organizational Affiliation
Valdoltra Orthopedic Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rihard Trebše, MD, PhD
Organizational Affiliation
Valdoltra Orthopedic Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Valdoltra Orthopedic Hospital
City
Ankaran
ZIP/Postal Code
6280
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No data will be shared with other researchers.

Learn more about this trial

Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty

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