T08 D18 D16.6
Conditions
Interventions
Group 1: Patients undergoing spinal surgery with pedicle screws using BonOs® Inject bone cement are followed up for a period of 2 years.
Sponsors
OSARTIS GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -All patients undergoing pedicle screw augmentation as indicated in the IFUs of the used screw system and BonOs® Inject. -Male or female = 18 years on the day of screening -Patient is willing to participate in the routine postoperative follow-up program -Patient has signed written informed consent
Exclusion criteria
Exclusion criteria: -Patients who do not meet the inclusion criteria and present any conditions contraindicated for BonOs® Inject or the used screw system -Severe generalized disease resulting in a life expectancy shorter than 12 months -Pregnant or breast-feeding women (urine pregnancy test) -Women of childbearing potential without effective contraception -Alcohol or drug abuse (clinical manifestation) -Subjects with psychiatric disorders influencing their judgment or autonomy -Inability or unwillingness to understand or comply with the required study procedures -Subject who are not suitable for the study based on the principal investigator’s evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Screw loosening rate indicated by a radiolucent zone (>1mm) surrounding the pedicle screw measured by X-ray | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and complications occurring intra- and post-operatively, cement leakage rate and patient’s outcome by (VAS) and (ODI). Cement handling | — |
Countries
Germany
Contacts
Public ContactIna Hallstein
OSARTIS GmbH
Outcome results
None listed