Hip OsteoarthritisNCT04101864
Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty
A study testing Electromagnetic navigation and Freehand in people with Hip Osteoarthritis, run by Valdoltra Orthopedic Hospital at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Electromagnetic navigation and Freehand
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSlovenia
- Study dates
- 4 May 2017to 2 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age under 18 years
- unwilling to participate
- prior surgery on affected hip
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- Electromagnetic navigation, Freehand
- Keywords
- navigation, hip arthroplasty, surgical time, landmark
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic navigationProcedure or surgery
Acetabular component placement in total hip arthroplasty will be performed wit the help of electromagnetic image-less navigation system.
FreehandProcedure or surgery
In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique.
| Study group | Role | What they receive |
|---|---|---|
| Electromagnetic navigation | Experimental | 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. Receives: Procedure: Electromagnetic navigation |
| Freehand | Active comparator | In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique. Receives: Procedure: Freehand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetabular component position
Comparison of the precision and the accuracy of acetabular components between both groups
Measured: Up to 48 hours after surgery
Secondary outcomes (2)
Surgical time
Comparison of duration of surgery between both groups
Measured: Immediately after surgical procedure
Clinical result
Comparison of improvement of Harris hip score between both groups
Measured: 8-10 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start4 May 2017
- Primary completion2 Feb 2018
- Study completion2 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valdoltra Orthopedic Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rene Mihalič, MD, Principal investigator, Valdoltra Orthopedic HospitalRihard Trebše, MD, PhD, Study director, Valdoltra Orthopedic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101864
- Sponsor's protocol ID
- 77/05/12
- Status last verified
- Sep 2019
- First submitted
- 9 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04101864
- Acronym / sponsor ID
- 77/05/12
- Conditions
- Hip Osteoarthritis
- Keywords
- navigation, hip arthroplasty, surgical time, landmark
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Valdoltra Orthopedic HospitalUniversity, hospital or other
- Study start
- 4 May 2017 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Electromagnetic navigation | Experimental | Procedure: Electromagnetic navigationIn 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. |
| Freehand | Active comparator | Procedure: FreehandIn the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- age under 18 years
- unwilling to participate
- prior surgery on affected hip
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromagnetic navigationAcetabular component placement in total hip arthroplasty will be performed wit the help of electromagnetic image-less navigation system. | Procedure or surgery | Electromagnetic navigation |
| FreehandIn the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique. | Procedure or surgery | Freehand |
Primary outcome
Acetabular component position
Time frame: Up to 48 hours after surgery
Comparison of the precision and the accuracy of acetabular components between both groups
2 secondary outcomes
Surgical time
Time frame: Immediately after surgical procedure
Clinical result
Time frame: 8-10 weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Individual participant dataSharing planned: No. No data will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rene Mihalič, MD principal investigator
Valdoltra Orthopedic Hospital
Rihard Trebše, MD, PhD study director
Valdoltra Orthopedic Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic navigation and Freehand in people with Hip Osteoarthritis, run by Valdoltra Orthopedic Hospital at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acetabular component position (time frame: Up to 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019; AzTrials last refreshed its copy on 2 Nov 2026.