- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07572292
Proof of Concept for Simulating Static Weight-bearing Exercises in the Supine Position (SWB_PoC)
Validation and Evaluation of a Static Supine Weight-Bearing Computed Tomography Method to Enable Detection of Implant Migration After Knee Arthroplasty
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicolas Van Vlasselaer, Master
- Phone Number: 555-5555
- Email: nicolas.van.vlasselaer@vub.be
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy participants
- Patients with TKA
Exclusion Criteria:
- neurological conditions
- acute trauma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Knee Arthroplasty
Patients with Knee Arthroplasty
|
Static supine weight bearing CT in addition to standard care RX
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Validation of static supine weight bearing against standing weight bearing using kinematic parameters
Time Frame: 1 year
|
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
Time Frame: 1 Year
|
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
Time Frame: 1 year
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 26015_SWB_PoC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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