PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
Recruiting
Observational Study
Degenerative Disc Disease (DDD)
Spinal Stenosis
Spondylolisthesis
Spinal Deformities
Spinal Tumors
Spinal Infections
Spinal Trauma
Vertebral Fractures
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 561 (estimated)
- Sponsor
- Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co. · Industry
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About This Trial
This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems, and Bonegraft® bone filling materials (synthetic bone grafts and bone cements). The study aims to evaluate short-term (12-month) safety and effectiveness, identify previous…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 18 years of age or older.
* Skeletally mature.
* Male or female.
* Undergone spinal surgery (cervical or thoracolumbar) for any indication under current medical practice.
* Titania® spinal stabilization/fusion systems and/or BONEGRAFT® bone cements or BONEGRAFT® bone graft mat…
Contacts