The primary objective of this study is to compare weight-bearing and non-weight-bearing low-field MRI scans of patients with instability, patellofemoral maltracking and suspected component loosening after primary total knee arthroplasty. The…
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Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters for assessing patellofemoral maltracking are
patellofemoral indices which are used for assessing patellar height and
medial-lateral patellar displacement. For the statistical analysis, a within
subject analysis is performed. The main study parameters for assessing
component rotation are angle measurements which are used for assessing femoral
and tibial component rotation. The assessment of soft tissue deformities will
be performed by a segmentation of the structures of interest and comparing the
volume and length of these structures with the knee in extension and multiple
angles of flexion. For the statistical analysis, a within subject analysis is
performed in which the structures will be visually inspected.
The main study parameter to assess component loosening is the amount of fluid
in the knee around the knee prosthesis. It is expected that compared to the
control group patients with suspected component loosening have an increased
amount of fluid around the kneeprosthesis.
Secondary outcome
Secondary endpoints are the inter-observer agreement and intra-observer
agreement. These are calculated using the Cohen*s kappa coefficient. The
results of two researchers will be included for these calculations.
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 system was introduced which offers the possibilities to scan the patient in
weight-bearing position and 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 any
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 objective
The primary objective of this study is to compare weight-bearing and
non-weight-bearing low-field MRI scans of patients with instability,
patellofemoral maltracking and suspected component loosening after primary
total knee arthroplasty. The secondary objective is to compare
non-weight-bearing low-field MRI scans of the patient*s knee in extension and
multiple angles of flexion of patients with instability and patellofemoral
maltracking related complaints after primary total knee arthroplasty.
Study design
A pilot study with sample size of 16 subjects will be carried out. This number
will be divided in 8 subjects with complaints and 8 subjects without
complaints.
Study burden and risks
Participation to this research takes approximately 2.5 hours of the subject*s
time, in addition to the possible regular care. The risk associated with
performing MRI examinations with patients with knee prosthesis is heating.
However, since this risk is already small in clinical high-field (1.5T) MRI,
the risk will be even smaller in low-field (0.25T) MRI. To perform the
weight-bearing scan, the participant needs to stand still for at most 15
minutes. During rotation of the MRI scanner to this position, the participant
might experience some dizziness. If this happens, the rotation of the MRI
scanner can be aborted immediately and the participant will be turned back to
horizontal position. Participation in this research has no consequences for the
regular care of the patient.
De Horst 2
Enschede 7522 LW
NL
De Horst 2
Enschede 7522 LW
NL
Listed location countries
Age
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
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64460.044.17 |
| OMON | NL-OMON29262 |