No registrations found.
ID
Source
Brief title
Health condition
Total knee arthroplasty
Patellofemoral problems
Instability
Component loosening
Sponsors and support
Intervention
Outcome measures
Primary outcome
o Patellofemoral indices
o Component rotation measurements
o Soft tissue deformations
o Moisture in the knee
Secondary outcome
o Intra-assessor agreement
o Inter-assessor agreement
Background summary
Total knee arthroplasty is a promising surgical procedure. However, around 20% of the patients report to be dissatisfied. Among the main causes for revision surgery are instability, amongst others caused by soft tissue deformities, patellofemoral complaints and component loosening. It is important to determine the specific causes for these types of complaints to effectively treat them. However, no objective diagnosis methods exist for specifying these types of pathologies. Recent studies conclude that these types of pathologies mainly arise during weight-bearing and knee bending activities. Recently, a low-field MRI stystem was introduced which offers the possibilities to scan the patient in weight-bearing position and in non-weight-bearing position with the knee in multiple angles of flexion. This study explores the relevance of diagnosing instability, patellofemoral maltracking and component loosening in weight-bearing, knee extension, and non-weight-bearing, knee extension and multiple angles of flexion, position in low-field MRI. Therefore, 8 subjects with the aforementioned types of complaints will be scanned during this study. In order to assess the MRI scans of the subjects with complaints, the same scan protocol will be applied to 8 subjects with knee prosthesis without complaints. The study parameters of the MRI scans from the subjects with complaints will be compared to the study parameters of the MRI scans from the subjects without complaints.
Study design
One scan procedure at the University of Twente with the MRI scanner
Intervention
Diagnostic test: MRI low-field weight-bearing
Diagnostic test: MRI low-field supine
Inclusion criteria
- Subject has a posterior stabilized knee prosthesis with a femur component made of Co-Cr-Mo, a tibia component made of Ti-6Al-4V, a polyethylene liner and optionally a polyethylene patella button
- Patient has signed informed consent
- Patient is older than 18 years
Exclusion criteria
- Patient has an inability to stand for 15 minutes, without assistance
- Patient is not eligible for MRI, based on MRI screening questionnaire
- Pregnancy
- The knee of the patient does not fit in the RF knee coil
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7009 |
| NTR-old | NTR7207 |
| CCMO | NL64460.044.17 |
| OMON | NL-OMON46504 |