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Not yet recruiting NCT07572292

Proof of Concept for Simulating Static Weight-bearing Exercises in the Supine Position

No phase Interventional Knee Arthroplasty, Total Healthy Participants

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: Static supine weight bearing CT.
Who it may be relevant to
Registry conditions: Knee Arthroplasty, Total, Healthy Participants. 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 →
Official title

Validation and Evaluation of a Static Supine Weight-Bearing Computed Tomography Method to Enable Detection of Implant Migration After Knee Arthroplasty

Overview

This project evaluates a new weight-bearing CT method to later improve early detection of implant migration after knee arthroplasty. This method aims to allow patients to apply a controlled load during CT scanning, simulating standing conditions with real-time feedback. The study has two phases. First, in healthy volunteers, biomechanical loading during prone simulated weight-bearing will be compared with a standard standing squat to validate the method. Second, in arthroplasty patients, standard radiographs will be compared with loaded and unloaded WBCT scans. Patients will not deviate from the standard plan of care. The CT images are additions to the standard RX images and are not intended for diagnostic purposes to the patient. The aim is to determine whether this method opens the door for more accurate and earlier detection of implant migration than current clinical imaging in the future, potentially improving long-term outcomes after knee arthroplasty.

Interventions

  • Diagnostic test Static supine weight bearing CT
    Static supine weight bearing CT in addition to standard care RX

Primary outcome measures

  • Validation of static supine weight bearing against standing weight bearing using kinematic parameters [Time frame: 1 year]
  • Validation of static supine weight bearing against standing weight bearing using kinetic parameters [Time frame: 1 Year]
  • Validation of static supine weight bearing against standing weight bearing using muscle activation [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Healthy participants
  • Patients with TKA

Exclusion criteria

  • neurological conditions
  • acute trauma

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07572292 · 26015_SWB_PoC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗