An interventional study of spondylodesis and CT in Spinal Cord Diseases, sponsored by Balgrist University Hospital. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-31.
Sponsored by Balgrist University Hospital · Not applicable, Interventional, and Treatment
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The clinically already tested and approved MySpine system is compared to the free-hand dorsal instrumentation, which is the gold standard in spondylodesis surgery. The aim of this study is to investigate whether or not the pedicle screw can be inserted anatomically more accurately by the MySpine system than by the conventional free-hand method using intraoperative fluoroscopy.
Patients with an indication for spondylodesis are included according to the inclusion criteria and exclusion criteria. Subsequently, randomization into the MySpine and conventional group is performed. Patients remain blinded to the randomization.
On the basis of a computed tomography, the surgeon plans the entry points, the screw size and length, as well as the angle of the screws in two planes (sagittal and axial) on the computer. In the MySpine group, a three-dimensional, digital reconstruction of the spine is made using Medacta International SA software. On the basis of these planning files, three-dimensional templates with guide channels (guides) are produced for each individual vertebra. These guides can be applied dorsally to the bony anatomy and thus specify the entry points as well as the direction of the screw. Also, replicas of the individual vertebra are produced in the 3D printer.
The patients are operated in a prone position via a dorsal approach. After preparation of the dorsal process, vertebral arches and vertebral joints as well as the transverse process, the screws are implanted with one of the following methods depending on the randomization:
Postoperatively, all patients undergo computed tomography of the operated area. On the basis of this computed tomography the number of pedicle perforations as well as their extent should be determined according to the simplified Laine classification. These results are to be statistically evaluated with the question of whether there are significant differences between the two techniques with respect to the absolute and individual number of pedicle perforations, as well as their extent. It is also to be examined whether these results show a dependence on the level of experience of the surgeon.
In addition to the individual radiation exposure (cumulative irradiation time in seconds and irradiation dose in cGy), the time for the dorsal instrumentation for each of the two systems per surgeon is also to be measured and evaluated.
In the follow-up, the outcome is also recorded by means of pain registration, ODI score and complication detection (infections, pedicle fractures, implant loosening, pseudoarthrosis, re-operations).
The follow-up assessments 6 weeks, 6 months, 1 year and 2 years after surgrey are peformed according to institutional standards.
170 studies on the registry are indexed under Spinal Cord Diseases; 56 are open to participants now.
This study's enrollment of 66 is above the median of 36 across 120 interventional studies indexed under Spinal Cord Diseases.
Browse Spinal Cord Diseases studies →Balgrist University Hospital is the lead sponsor of 81 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
pedicle screw implantation (spondylodesis) using the MySpine System. post surgery CT.
Procedure: spondylodesis · Procedure: CT
Freehand (fluoroscopically controlled) implantation of pedicle screw (spondylodesis). Post surgery CT
Procedure: spondylodesis · Procedure: CT
Dorsal instrumentation with transpedicular screws (spondylodesis)
CT of operated area is performed within 7 days of surgery
accuracy
Anatomical accuracy of pedicle screw implantation (intactness of the pediculate cortex in 3 planes), postoperatively measured via computertomographically existing or nonexisting pedicle perforation and their extent according to the simplified Laine classification: Grade A (\<2 mm), Grade B (2-4 mm) and Grade C (\> 4 mm)
Time frame: within 7 days post surgery
duration
Intraoperative time spent on dorsal Instrumentation is documented and compared between the groups
Time frame: during surgery
Radiation exposure
cummulative Radiation exposure during surgery is measured and compared between the groups
Time frame: during surgery
blood loss
blood loss during surgery is documented and compared between the groups
Time frame: during surgery
complications
intraoperative and post-operative complications such as pedicle fractures, implant loosening, infections and pseudo arthrosis are documented and compared between the groups
Time frame: during surgery until end of follow up (24 months after surgery)
reoperations
reoperations are documented and compared between the groups
Time frame: until end of follow up (24 months after surgery)
Plan to share: No — IPD only available to study personnel. statistical Analysis will be done with encoded data only. study results will be published
No publications or documents are linked to this record.
Ran from Jun 2017 to primary completion in Mar 2024, 81 months.
Of 54 non-industry interventional studies with no phase under Spinal Cord Diseases, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 81. This study's 81 months is above that.
Counting every sponsor, half of 58 studies reached it within 48 months; a quarter within 20 and three quarters within 95.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Balgrist University Hospital