Total Hip Arthroplasty
Conditions
Keywords
implant position, leg length
Brief 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.
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.
Interventions
DEVICEMyHip Verifier
Numerical information on the position of the implant is provided to the surgeon.
Sponsors
Basel Academy for Quality and Research in Medicine
Marcel Jakob
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Scheduled for THA 2. Age of 18 or above
Exclusion criteria
1. Patients with anatomical conditions which reduce the applicability of the software 2. Patients with implants which reduce the applicability of the software 3. Patients who cannot perform an upright X-ray
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean absolute difference between measured value and reference value | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean amount of repositioning performed by the surgeon | This measure involves two time points: Starting and stopping of the software during surgery. | The mean absolute difference between the value measured by the software when started and the final value |
| Mean absolute improvement in reaching the target value | This measure involves three time points: Determining target values prior to surgery and starting and stopping the software during surgery, | 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. |
Contacts
Primary ContactMarcel Jakob, MD
Backup ContactWerner Vach, PhD
Outcome results
None listed