Inducible Displacement in Total Knee Prostheses

Completed

• Conditions: aseptic loosening; imlant migration; 10005944

• Registration Number: NL-OMON42998
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Patients will be included if
• they underwent TKR for primary as well as secondary gonarthrosis as long as the indication for surgery is clearly specified
• a minimal set of patient characteristics (age, gender, BMI, co-morbidity) and disease characteristics (radiological severity, knee function and alignment, status of other knee or hip joints, previous surgeries of the affected knee) is available.
• they are at least *up to date* in terms of follow-up of their respective study (i.e. the most recent examination was less than a year ago and patients have a post-operative examination)
• they participated for at least three years in their respective study and have a usable MTPM-value (i.e. >= 3 bone-markers can be consistently matched with the reference-examination with a CN < 120 over the most recent two years of follow-up
• their standard RSA data meets the criteria as mentioned in the ISO-standard
• they are willing to participate and able to perform the 4 pre-set tasks for the inducible displacement measurements

Exclusion Criteria

Patients will be excluded from participation if they do not meet the inclusion criteria, or if they already underwent revision surgery of their TKR since the start of the study they were enrolled in.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Inducible displacement expressed in mm (translations) and degrees (rotations)<br /><br>measured during the peak-force application of the different loading regimes.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The association of the measured induced displacement of the tibial tray<br /><br>relative to the bone -expressed in translations (mm) and rotations (degrees)-<br /><br>with the measured longitudinal migration data to identify which combination of<br /><br>loading regimes (i.e. force applied versus non-weight bearing examinations)<br /><br>yields the best discrimination between potentially loose and properly fixed<br /><br>implants. </p><br>