Conditions causing lumbar spinal instability, spondylolisthesis, spinal stenosis, fractures, degenerative disc disease Conditions causing an unstable spine in the lower back, slipped vertebra, narrowing of the spinal canal, broken vertebra, aging-related disc problems
Conditions
Interventions
In the intervention group, screw placement will be guided by 3DPGs, while in the control group, standard CAS navigation will be used. 
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients indicated for 1-level surgical lumbar fixation (with or without fusion); Bilateral CBT screw placement must be possible;Surgery must be elective or semi-elective; Patients are at least 18 years of age.
Exclusion criteria
Exclusion criteria: Preoperative imaging clearly indicates that CBT screw insertion is not feasible due to patient-specific anatomical factors, such as small pedicles;High-grade spondylolisthesis (Meyerding grade III or IV); Urgent cases that require surgery within one week (currently, at least five working days after the pre-operative CT are required for 3D planning and 3DPG production);Presence of osteosynthesis material in the vertebrae planned for screw insertion; History of revision surgery or laminectomy;History of spina bifida;More than one symptomatic level requiring fixation;Vertebrae levels planned for unilateral screw insertion; Vertebrae with osteoporotic fracture or infection;Scoliosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is the radiological accuracy of CBT screw placement. The radiological accuracy will be measured as the deviation from the planned trajectory, measured with the continuous variables (1) angular deviation in degrees (º), and (2) entry point deviation in mm. These parameters will be compared between 3DPGs and CAS navigation. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Gertzbein-Robbins Classification; (2) usability and (3) satisfaction for operating room staff; (4) total surgical time; (5) blood loss; (6) clinical outcomes; and (7) Incidence of intraoperative and postoperative complications. | — |
Countries
Netherlands
Contacts
Public ContactH.L. Li
Universitair Medisch Centrum Groningen
Outcome results
None listed