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| Name | Class |
|---|---|
| Basel Academy for Quality and Research in Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | All patients included in the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyHip Verifier | Device | Numerical information on the position of the implant is provided to the surgeon. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | This measure involves two time points: Starting and stopping of the software during surgery. |
| Mean absolute improvement in reaching the target value |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing total hip arthrosplasty
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcel Jakob, MD | Contact | +41 61 285 1042 | marcel.jakob@crossklinik.ch | |
| Werner Vach, PhD | Contact | +41 61 285 1034 | werner.vach@basel-academy.ch |
| Name | Affiliation | Role |
|---|---|---|
| Marcel Jakob, MD | crossklinik AG | Principal Investigator |
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An anonymized version of the statistical analysis data set will be published as part of the main publication.
IPD will be available at the date of publication of the main manuscript.
There are no access criteria.
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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. |
| This measure involves three time points: Determining target values prior to surgery and starting and stopping the software during surgery, |