The primary objective is to compare the accuracy of the five-dimensional (5D) calibrator device for glenoid positioning with the accuracy of the conventional (freehand) method.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The accuracy of the positioning of the glenoid component, measured on a CT-scan
Secondary outcome
Position of the prothesis
Range of motion
Adverse events
PROMs: NRS, DASH, Constant Murley score, Oxford shoulder test, EQ-5D
Additional costs of surgery (planning)
Background summary
The correct positioning and fixation of the glenoid component is one of the
most important challenges of the procedure and has a significant impact on the
postoperative clinical outcomes. Recently, a reusable five-dimensional (5D)
Patient specific instrumentation has been developed which likely improves the
accuracy and precision of the glenoid component position. Since this is a
relatively new system, studies comparing the accuracy of the 5D calibrator
device for glenoid positioning with the accuracy and postoperative outcomes of
the conventional (freehand) method, are lacking.
Study objective
The primary objective is to compare the accuracy of the five-dimensional (5D)
calibrator device for glenoid positioning with the accuracy of the conventional
(freehand) method.
Study design
interrupted time series
Study burden and risks
The same risks exist as one would experience in standard care, other than the 2
year follow-up at which patients are asked to fill in questionaires and they
will undergo an extra CT-scan a directly postoperatively and an x-ray at 2
years follow-up. The CT-scans will results in additional radiation. The main
health risk associated with radiotion is the occurance of cancer.
Tegelseweg 210
Venlo 5912 BL
NL
Tegelseweg 210
Venlo 5912 BL
NL
Listed location countries
Age
Inclusion criteria
- Scheduled for a reverse shoulder arthroplasty (for one of the following
indications:
rotator cuff tear arthropathy; irreparable rotator cuff tear, osteoarthritis,
rheumatoid artritis) according to the freehand or 5D method.
- Provide written informed consent
Exclusion criteria
- Inability to understand written or verbal Dutch language
Design
Recruitment
Medical products/devices used
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 | NL75131.068.20 |