To Establish the usefulness of MRI for assessment of the rotator cuff in patients with an Affinis short prosthesis implanted in the shoulder.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Interpretation and value of MR-imaging of the rotator cuff with prosthesis in
situ
Secondary outcome
Interpretation of MR-imaging of condition of the bone stock
Interpretation and usefulness of MR-imaging results in diagnosis of: glenoid
pathology, position of the prosthesis,
loosening of the prosthesis, polyethylene wear and determining if there might
be an infection.
Background summary
normally a MRI is not a good way to evaluate the rotator cuff after placing a
shoulder prosthesis. because of the prosthesis this isn't possible, especially
because of the cobalt chroom containment. this prosthesis doesn't contain
cobalt chroom, so we think it is possible to get a good clear view on the
rotator cuff. so we can have a follow-up and maybe see in the future the moment
to place another prosthesis.
Study objective
To Establish the usefulness of MRI for assessment of the rotator cuff in
patients with an Affinis short prosthesis implanted in the shoulder.
Study design
All the patients will have received their normal postoperative follow-up. They
will have been seen two, six and twelve weeks after the operation. The MRI*s
for this diagnostic study will be conducted after six and twelve months, but
all the patients that had an MRI scan done pre-operatively with a clear
clinical indication may be included as well.
Study burden and risks
the normal risks of making a MRI,
Specific MRI incompatibility such as severe claustrophobia or patients with
pregnancy,implanted electronic devices, such as pacemakers, internal
defibrillators, some cochlear implants and nerve stimulators. Patients
with
ferromagnetic aneurysm clips in the brain or ferromagnetic objects in
critical
places like the eye, brain, lung.
Molengracht 21
4818 CK Breda
NL
Molengracht 21
4818 CK Breda
NL
Listed location countries
Age
Inclusion criteria
only people with an Affinis short shoulder prosthesis will be included
Exclusion criteria
claustrophobia, contra-indication MRI, insufficient knowledge Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL34779.101.12 |