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

NCT07107282 | Not Yet Recruiting FDA Device

• 1 other identifier: VerifierVerifier
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Total Hip Arthroplasty

Keywords

implant position; leg length

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Mean amount of repositioning performed by the surgeon

  This measure involves two time points: Starting and stopping of the software during surgery.

• 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,

Study Arms (1)

All patients

All patients included in the study

Device: MyHip Verifier

Interventions

MyHip Verifier DEVICE

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

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing total hip arthrosplasty

You may qualify if:

• Scheduled for THA
• Age of 18 or above

You may not qualify if:

• 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

Sponsors & Collaborators

• Marcel Jakob: lead
• Basel Academy for Quality and Research in Medicine: collaborator

Study Officials

• Marcel Jakob, MD

  crossklinik AG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 6, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be available at the date of publication of the main manuscript.
• Access Criteria: There are no access criteria.