DRKS00024355
Recruiting
N/A
A prospective observational study to evaluate the safety and performance of BonOs® Inject bone cement used in cement-augmented pedicle screw fixation
OSARTIS GmbH0 sites90 target enrollmentJune 14, 2021
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- T08
- Sponsor
- OSARTIS GmbH
- Enrollment
- 90
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\-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
Outcomes
Primary Outcomes
Not specified
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