Spinal Instability
Conditions
Interventions
The intervention in this study is the 3D virtual surgical planning and the use
of patient specific guides for spinal screw insertion in one half of the
patient*s spine.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Patients are awaiting surgical fixation of the cervical and/or thoracic spine. * Preoperative CT has to be available * Surgery must be elective or semi-elective. * Surgery must involve the placement of pedicle- or lateral mass screws * The patients are at least 16 years of age.
Exclusion criteria
Exclusion criteria: * Urgent cases that require surgery within 5 days * Presence of osteosynthesis material in the vertebrae planned for screw insertion. * Revision surgery, or laminectomy performed in earlier stage. * Vertebrae levels are planned for unilateral screw insertion * Scoliosis cases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The radiological accuracy will be measured as the deviation (i.e. error) from planned trajectory, with the continuous variables; (1) entry point deviation (mm), and (2) angular deviation (degrees º). These parameters will be measured and compared between both techniques. | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary endpoint the accuracy results of both techniques will be compared within specific spinal regions: (1) Atlanto-Axial spine, (2) the sub-axial spine, (3) the cervical spine, and (4) the thorarcic spine. For pedicle screws, mutual techniques will also be compared according to the Rampersaud safety classification | — |
Countries
Netherlands
Outcome results
None listed