Evaluation of a Software to Predict the Postoperative Component Position in Total Hip Arthroplasty (THA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MyHip Verifier.
- Who it may be relevant to
- Registry conditions: Total Hip Arthroplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Device MyHip Verifier
Numerical information on the position of the implant is provided to the surgeon.
Primary outcome measures
- 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.]
Secondary outcome measures (2)
- 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,]
Eligibility criteria
Inclusion criteria
- Scheduled for THA
- Age of 18 or above
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07107282 · VerifierVerifier