The objectives are to determine the accuracy and reliability of sCT compared to conventional CT regarding (1) classification ofshoulder osteoarthritis morphology and (2) planning for the 3D-position of a compound used for shoulderreplacement surgery…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
3D parameter glenoid height.
Secondary outcome
Other 3D parameters (glenoid inclination, version, surface area, and width and
humeral inclination, version and surface area) and morphology classifications
systems that I are used in the evaluation of shoulder osteoarthritis (Walch
classification and Sirveaux classification).
Background summary
Shoulder osteoarthritis (OA) is a leading cause of chronic shoulder pain and is
rising in prevalence
due to an aging population, currently showing a 20% prevalence above 65
years.1-3
Shoulder replacement
surgery has become the gold standard and most executed surgery for severe
shoulder OA and is expected to
demonstrate a 755.6% increase in 2030 compared to 2011.1,4,5 To ensure
effective and safe treatment, ideally
two preoperative scans are made. CT is most suitable to determine OA severity
and to determine glenoid
morphological parameters for surgical planning, whereas MRI or ultrasound
determines the optimal type of
prosthesis by visualising damage to the rotator-cuff muscles.1-6 However,
ultrasound is often inconclusive and
MRI is generally not performed, as making two scans is costly and requires more
planning with the patient.
Deep-learning software has the ability to create synthetic CT (sCT) images
through MRI-images and allows
for visualisation of both soft tissue and bony structures with a single scan.
sCT has shown equivalence to
conventional CT in bony structures, such as the hip and lumbar spine, and may
be a one-stop-shop solution
for the narrow shoulder structures as well.7-8 The additional information of
soft-tissue damage supports
decision making and patient selection, eliminates radiation exposure and
improves the workflow, as only one
scan needs to be planned. Furthermore, healthcare costs may be decreased by
eliminating one scan and
improved patient selection may prevent revision surgery.4,9,10
Between March 2022 and April 2023 a successful pilot study was performed with
paired data of
instability patients, which demonstrated equivalence of sCT to CT. This
provided the basis for the algorithm
to be trained with more complex structures, such as the osteoarthritic
shoulder.
Study objective
The objectives are to determine the accuracy and reliability of sCT compared to
conventional CT regarding (1) classification of
shoulder osteoarthritis morphology and (2) planning for the 3D-position of a
compound used for shoulder
replacement surgery through glenoid parameters acquired with 3D planning
software (Blueprint).
Study design
This prospective diagnostic study with equivalence design.
Study burden and risks
An additional MRI-scan will be made. An MRI of the shoulder typically takes 30
minutes. With the new technique 4:12 minutes will be added to this the
scantime. The additional MRI was take +- 35 minuten.
Vlaardingenlaan 574
Amsterdam 1068LH
NL
Vlaardingenlaan 574
Amsterdam 1068LH
NL
Listed location countries
Age
Inclusion criteria
A subject must meet all of the following criteria in order to be eligible for
this study:
1. An indication from the orthopaedic surgeon to undergo total shoulder
arthroplasty and undergo a CT scan to evaluate osteoarthritis of the shoulder
according to the standard care protocol;
2. 18 years or older.
Exclusion criteria
1. Patients with previous shoulder replacement surgery or fracture sequalae of
the humerus or glenoid.
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 | NL85845.100.24 |