Total Hip ArthroplastyNCT07107282
Evaluation of a Software to Predict the Postoperative Component Position in Total Hip Arthroplasty (THA)
An observational study of Total Hip Arthroplasty, run by Marcel Jakob.
Trial summary
The goal of this observational study is to learn about the accuracy of a software determining the implant position during THA surgery. Measurements made with the software are compared to reference values determined on X-rays. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- MyHip Verifier
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients undergoing total hip arthrosplasty
Who may be able to join
- Scheduled for THA
- Age of 18 or above
Who cannot join
- Patients with anatomical conditions which reduce the applicability of the software
- Patients with implants which reduce the applicability of the software
- Patients who cannot perform an upright X-ray
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of a Software to Predict the Postoperative Component Position in Total Hip Arthroplasty (THA): Accuracy of Predictions and Impact on Interoperative Placement in a Single Centre
The goal of this observational study is to learn about the accuracy of a software determining the implant position during THA surgery.
Measurements made with the software are compared to reference values determined on X-rays.
Read the detailed description
The software is based on comparing an pre-operative fluoroscopy-based image with inter-operative fluoroscopy-based image. Three numerical values are provided: "leg length", "lateral offset" and "inclination".
Correponding reference values are determined based on pre-operative and post-operative X-rays.
- Conditions
- Total Hip Arthroplasty
- Being tested
- MyHip Verifier
- Keywords
- implant position, leg length
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyHip VerifierDevice
Numerical information on the position of the implant is provided to the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| All patients | All patients included in the study Receives: Device: MyHip Verifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute difference between measured value and reference value
The mean absolute difference between the final value measured by the software and the reference value determined on a postoperative X-ray.
Measured: This measure involves two time points: Stopping of the software during surgery and performing the postoperative X-ray. The latter is usually the first day after surgery. A delay is allowed if a patient cannot perform an upright X-ray.
Secondary outcomes (2)
Mean amount of repositioning performed by the surgeon
The mean absolute difference between the value measured by the software when started and the final value
Measured: This measure involves two time points: Starting and stopping of the software during surgery.
Mean absolute improvement in reaching the target value
The mean value of the change in absolute difference between the actual position and the target value from starting the software until stopping the software.
Measured: This measure involves three time points: Determining target values prior to surgery and starting and stopping the software during surgery,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marcel Jakob
- Sponsor type
- University, hospital or other
- Collaborators
- Basel Academy for Quality and Research in Medicine
- Responsible party
- Sponsor-investigator, Marcel Jakob, crossklinik AG
- Investigators
- Marcel Jakob, MD, Principal investigator, crossklinik AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107282
- Sponsor's protocol ID
- VerifierVerifier
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: An anonymized version of the statistical analysis data set will be published as part of the main publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Software to Predict the Postoperative Component Position in Total Hip Arthroplasty (THA): Accuracy of Predictions and Impact on Interoperative Placement in a Single Centre
- ClinicalTrials.gov ID
- NCT07107282
- Acronym / sponsor ID
- VerifierVerifier
- Conditions
- Total Hip Arthroplasty
- Keywords
- implant position, leg length
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marcel JakobUniversity, hospital or other
- Collaborators
- Basel Academy for Quality and Research in Medicine
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 6 Aug 2025 (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.
The goal of this observational study is to learn about the accuracy of a software determining the implant position during THA surgery.
Measurements made with the software are compared to reference values determined on X-rays.
Detailed description
The software is based on comparing an pre-operative fluoroscopy-based image with inter-operative fluoroscopy-based image. Three numerical values are provided: "leg length", "lateral offset" and "inclination".
Correponding reference values are determined based on pre-operative and post-operative X-rays.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Device: MyHip VerifierAll patients included in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing total hip arthrosplasty
Key inclusion criteria (2 listed)
- Scheduled for THA
- Age of 18 or above
Key exclusion criteria (3 listed)
- Patients with anatomical conditions which reduce the applicability of the software
- Patients with implants which reduce the applicability of the software
- Patients who cannot perform an upright X-ray
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 |
|---|---|---|
| MyHip VerifierNumerical information on the position of the implant is provided to the surgeon. | Device | All patients |
Primary outcome
Mean absolute difference between measured value and reference value
Time frame: This measure involves two time points: Stopping of the software during surgery and performing the postoperative X-ray. The latter is usually the first day after surgery. A delay is allowed if a patient cannot perform an upright X-ray.
The mean absolute difference between the final value measured by the software and the reference value determined on a postoperative X-ray.
2 secondary outcomes
Mean amount of repositioning performed by the surgeon
Time frame: This measure involves two time points: Starting and stopping of the software during surgery.
Mean absolute improvement in reaching the target value
Time frame: This measure involves three time points: Determining target values prior to surgery and starting and stopping the software during surgery,
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: Yes. An anonymized version of the statistical analysis data set will be published as part of the main publication.
Related trials for Total Hip Arthroplasty
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Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
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Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial
Anaesthetic Requirements During Total Hip Arthroplasty
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
Not yet recruiting
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
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.
Marcel Jakob, MD principal investigator
crossklinik AG
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty, run by Marcel Jakob.
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 2 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: opening soon, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcel Jakob, MD (+41 61 285 1042, marcel.jakob@crossklinik.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute difference between measured value and reference value (time frame: This measure involves two time points: Stopping of the software during surgery and performing the postoperative X-ray. The latter is usually the first day after surgery. A delay is allowed if a patient cannot perform an upright X-ray.). 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 6 Aug 2025.