Health TrialsbyHealthPanel

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

ConditionTotal Hip Arthroplasty
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMarcel Jakob

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled for THA

Age of 18 or above

Disqualifiers

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

Trial population

Patients undergoing total hip arthrosplasty

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MyHip Verifier

    Device

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

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: All patients1 intervention

Trial outcomes

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.

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 outcomes

1

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

Time frame
This measure involves two time points: Starting and stopping of the software during surgery.
2

Mean absolute improvement in reaching the target value

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.

Time frame
This measure involves three time points: Determining target values prior to surgery and starting and stopping the software during surgery,

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marcel Jakob

Lead sponsor

crossklinik AG

Sponsor institution

Basel Academy for Quality and Research in Medicine

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: