The study investigates postoperative pedicle screw loosening following posterior lumbar spinal fusion and its association with preoperative CT-based bone density.
Conditions
Interventions
Group 1: For this study, only computed tomography (CT) examinations of the lumbar spine or thoracolumbar junction that were obtained as part of routine clinical care will be analyzed. These include pr
Sponsors
GFO Kliniken Rhein-Berg, Zentrum für Wirbelsäulenchirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients who underwent posterior lumbar pedicle screw–rod instrumentation involving a maximum of three spinal motion segments. - Availability of preoperative imaging, including a CT examination suitable for reliable assessment of bone density. - A minimum follow-up period of up to 12 months, during which radiological follow-up examinations, particularly CT scans, are available for the assessment of possible pedicle screw loosening. - Availability of complete clinical and radiological documentation throughout the observation period, including operative reports, preoperative and postoperative imaging, and follow-up documentation. - Documented indication for posterior lumbar instrumentation, classified as either: -- Traumatic pathology (e.g., vertebral fracture or sequelae of spinal injury), or -- Degenerative pathology (e.g., lumbar spinal stenosis, degenerative spondylolisthesis, or spinal instability).
Exclusion criteria
Exclusion criteria: if the inclusion criteria were not met
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint Occurrence of radiographically confirmed pedicle screw loosening within 12 months following implantation of a lumbar posterior pedicle screw–rod instrumentation. Radiographic Definition of Pedicle Screw Loosening Pedicle screw loosening is defined by the presence of at least one of the following radiographic criteria: - Development of a radiolucent halo = 1 mm surrounding the pedicle screw - Screw migration or change in screw position compared with the immediate postoperative imaging - Screw loosening resulting in implant instability or requiring revision surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints - Association between preoperative CT-based bone density (measured in Hounsfield units) and the occurrence of pedicle screw loosening - Changes in bone density during the first postoperative year - Influence of clinical risk factors (age, body mass index [BMI], and smoking status) - Influence of the underlying pathology (degenerative vs. traumatic) - Influence of the number of instrumented spinal segments | — |
Countries
Germany
Contacts
Public ContactHabib Bendella
GFO Kliniken Rhein-Berg, Zentrum für Wirbelsäulenchirurgie
Outcome results
None listed