C41.2 D16.6 M53.2 M53.9 M45.0 M46.0 M46.2 M46.5 M46.8 M46.9 M47.1 M47.2 M47.8 M48.0 M48.1 M48.3 M48.4 M48.5 M48.8 M48.9 M49.4 M49.5 M49.8 S22.0 S22.1 S32.0 G55.2 G55.3
Conditions
Interventions
Group 1: Patients (at least 18 years old, with finished skeletal growth, who are willing and able to give an informed consent on their own) who received the SAMSON vertebral body replacement system o
Sponsors
HumanTech Spine GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Have been treated using the SAMSON® Vertebral Body Replacement System until 31.08.2023 2. Have a follow-up visit at least 9 months after surgery 3. Have been at least 18 years old and skeletally matured at the time of surgery 4. Is willing and able to provide a signed and dated informed consent, comply with the study plan
Exclusion criteria
Exclusion criteria: 1. Have had/ have any absolute contraindications listed in the information for use (IFU) 2. SAMSON® Vertebral Body Replacement System was used at the cervical spine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The loss of correction in the sagittal angle in the time between surgery and the follow-up 12 ± 3 months after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of this PMCF-study are: - Success of the treatment by achieving the preoperative surgery goals at the postoperative visits (prior to discharge from hospital, 12 ± 3 months visit) - Correction of the anatomical height of the defect (no, partially, completely correction) at the postoperative visits (prior to discharge from hospital, 12 ± 3 months visit) - Improvement in lordosis/ kyphosis profile (no, partially, completely improvement) of the spine at the postoperative visits (prior to discharge from hospital, 12 ± 3 months visit) - Evaluation of the occurrence of all device and/or procedure related adverse events from enrolment to the postoperative visits (prior to discharge from hospital, 12 ± 3 months visit), including occurrence of adverse events that occurred during MRI examination (if applied) at the postoperative visits (prior to discharge from hospital, 12 ± 3 months visit) - Measurement of the positional stability of the implant by: • Measurement of the occurrence of dislocation, loosening or defects of the implant(s) at the postoperative visits (prior to discharge from hospital, 12 ± 3 months visit) • Determining the degree of subsidence (no, minor (= 2mm), major (> 2 mm) subsidence) at the postoperative visits (prior to discharge from hospital, 12 ± 3 months visit) - Measurement of non-union signs (implant dislocation, implant defect, no signs) at the postoperative visits (prior to discharge from hospital, 12 ± 3 months visit) - Changes in patient-reported pain (Reduction from the baseline to 12 ± 3 months postoperatively) | — |
Countries
Germany
Contacts
Public ContactRoland Rißel
Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd
Outcome results
None listed