A prospective observational study to evaluate the safety and performance of BonOs® Inject bone cement used in cement-augmented pedicle screw fixatio

Recruiting

• Conditions: T08; D18; D16.6; Fracture of spine, level unspecified; Haemangioma and lymphangioma, any site; Vertebral column

• Registration Number: DRKS00024355
• Lead Sponsor: OSARTIS GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Screw loosening rate indicated by a radiolucent zone (>1mm) surrounding the pedicle screw measured by X-ray

Secondary Outcome Measures

Name	Time	Method
Adverse events and complications occurring intra- and post-operatively, cement leakage rate and patient’s outcome by (VAS) and (ODI). Cement handling