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NCT Number: NCT07107282

Evaluation of a Software to Predict the Postoperative Component Position in Total Hip Arthroplasty (THA)

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.

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Key information

Conditions

Total Hip Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MyHip Verifier

Device

Numerical information on the position of the implant is provided to the surgeon.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean amount of repositioning performed by the surgeon

    Time frame: 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

  2. 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,

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marcel Jakob, MD

CONTACT

[email protected]

+41 61 285 1042

Werner Vach, PhD

CONTACT

[email protected]

+41 61 285 1034

Sponsors and collaborators

Lead sponsor

Marcel Jakob

Other

Collaborators

  • Basel Academy for Quality and Research in Medicine

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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