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

NCT07572292 | Not Yet Recruiting DMC

• 1 other identifier: 26015_SWB_PoC
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Knee Arthroplasty, Total; Healthy Participants

Outcome Measures

Primary Outcomes (3)

• Validation of static supine weight bearing against standing weight bearing using kinematic parameters

  Comparison of lower-limb and trunk joint kinematics between static supine weight-bearing and standing weight-bearing conditions in healthy subjects using marker-based motion capture. Unit of Measure: Degrees (°)

  1 year

• Validation of static supine weight bearing against standing weight bearing using kinetic parameters

  Comparison of ground reaction forces and joint moments between static supine weight-bearing and standing weight-bearing conditions in healthy subjects using force plate measurements. Unit of Measure: Newtons (N) and Newton-meters (Nm)

  1 Year

• Validation of static supine weight bearing against standing weight bearing using muscle activation

  Comparison of lower-limb muscle activation patterns between static supine weight-bearing and standing weight-bearing conditions in healthy subjects using surface electromyography. Unit of Measure: Percentage of maximum voluntary contraction (%MVC)

  1 year

Study Arms (1)

Knee Arthroplasty

EXPERIMENTAL

Patients with Knee Arthroplasty

Diagnostic Test: Static supine weight bearing CT

Interventions

Static supine weight bearing CT DIAGNOSTIC_TEST

Static supine weight bearing CT in addition to standard care RX

Knee Arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy participants
• Patients with TKA

You may not qualify if:

• neurological conditions
• acute trauma

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Central Study Contacts

Nicolas Van Vlasselaer, Master

CONTACT

555-5555; nicolas.van.vlasselaer@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share