- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04101864
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
-
-
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Ankaran, Slovenia, 6280
- Valdoltra Orthopedic Hospital
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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.
|
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.
|
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
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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
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8-10 weeks postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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