A prospective observational study to evaluate the safety and performance of BonOs® Inject bone cement used in cement-augmented pedicle screw fixation
Organizational Data
- DRKS-ID:
- DRKS00024355
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2021-06-14
- Last update in DRKS:
- 2024-04-11
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The objective of this study is to collect data as a clinical follow-up in order to better assess how safe and effective the use of BonOs® Inject bone cement is. BonOs® Inject has already been certified as a medical device for use in spinal cord surgery and will be used according to standard clinical routine. After surgery, participants will be followed up for two years to identify any screw loosening or side effects.
Brief summary in scientific language
This post-market clinical follow-up study is designed to evaluate the efficacy and safety of the BonOs® Inject bone cement in screw augmentation procedures. BonOs® Inject is CE-marked medical device which will be used within its approved labelling. Patients undergoing vertebral augmenation procedures will be included and treated according to local standard of care. Patients will be followed-up for two years after surgery. The performance of BonOs® Inject will be evaluated based on the rate of screw loosening indicated by a radiolucent zone surrounding the pedicle screw measured by X-ray. Safety will be evaluated by the rate of symptomatic adverse events in comparison to the literature derived expected rate.
Health condition or problem studied
- ICD10:
- T08 - Fracture of spine, level unspecified
- ICD10:
- D18 - Haemangioma and lymphangioma, any site
- ICD10:
- D16.6 - Vertebral column
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Patients undergoing spinal surgery with pedicle screws using BonOs® Inject bone cement are followed up for a period of 2 years.
Endpoints
- Primary outcome:
- Screw loosening rate indicated by a radiolucent zone (>1mm) surrounding the pedicle screw measured by X-ray
- Secondary outcome:
- Adverse events and complications occurring intra- and post-operatively, cement leakage rate and patient’s outcome by (VAS) and (ODI). Cement handling
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Klinikum Fulda gAG Fulda
- University medical center Universitätsklinikum Gießen Gießen
- University medical center Johann-Wolfgang-Goethe Universität, Universitätsklinikum Frankfurt Frankfurt
Recruitment period and number of participants
- Planned study start date:
- 2021-06-24
- Actual study start date:
- 2021-08-18
- Planned study completion date:
- 2025-07-18
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 90
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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
Addresses
Primary Sponsor
- Address:
- OSARTIS GmbHAuf der Beune 10164839 MünsterGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- OSARTIS GmbHIna HallsteinAuf der Beune 10164839 MünsterGermany
- Telephone:
- +49 (0) 6071 - 929 - 0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://osartis.de/
Contact for Public Queries
- Address:
- OSARTIS GmbHIna HallsteinAuf der Beune 10164839 MünsterGermany
- Telephone:
- +49 (0) 6071 - 929 - 0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://osartis.de/
Principal Investigator
- Address:
- OSARTIS GmbHIna HallsteinAuf der Beune 10164839 MünsterGermany
- Telephone:
- +49 (0) 6071 - 929 - 0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://osartis.de/
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- OSARTIS GmbHAuf der Beune 10164839 MünsterGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Landesärztekammer HessenHanauer Landstraße 15260314 Frankfurt am MainGermany
- Telephone:
- +49-69-97672209
- Fax:
- +49-69-97672377
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-01-22
- Ethics committee number:
- 2021-2267-evBO
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-05-21
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry