Health Trials

PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials

ConditionsDegenerative Disc Disease (DDD)Spinal StenosisSpondylolisthesisSpinal DeformitiesSpinal TumorsSpinal InfectionsSpinal TraumaVertebral Fractures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMetrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.

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 previously unknown side effects, monitor defined complications, and assess risks based on real-world evidence in patients undergoing spinal surgery. All investigated products are used within their intended purpose under routine clinical practice.

Eligibility criteria

Qualifiers

18 years of age or older.

Skeletally mature.

Male or female.

Undergone spinal surgery (cervical or thoracolumbar) for any indication under current medical practice.

Disqualifiers

Participation in another interventional clinical investigation

Suspected or confirmed pregnancy

Morbid obesity

Neurological or psychiatric conditions preventing compliance with postoperative care and instructions

Trial design

Treatments tested in this trial

  • Titania® Cervical Interbody Fusion Cage (Titanium)
  • Titania® Cervical Interbody Fusion Cage (PEEK)
  • Titania® Posterior Cervical Stabilization System
  • Titania® Cervical Plate System
  • Titania® Cervical Dynamic Stabilization System (Elastic Rod)
  • Titania® Cervical Disc Prosthesis (Titanium)
  • Titania® Cervical Disc Prosthesis (PEEK)
  • Titania® Lumbar Interbody Fusion Cages (Titanium)
  • Titania® Lumbar Interbody Fusion Cages (PEEK)
  • Titania® Interspinous Fusion Device (Titanium)
  • Titania® Posterior Thoracolumbar Stabilization Systems
  • Titania® Posterior Thoracolumbar Clamp Systems
  • Titania® Thoracolumbar Dynamic Stabilization System (Elastic Rod)
  • Bonegraft® Synthetic Bone Grafts
  • Bonegraft® Bone Cement

Treatment groups

561 Participants
are divided into 17 treatment groups

17

Treatment groups

See each treatment group below.

Sponsors and collaborators

Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.

Lead sponsor

Bonegraft Biyolojik Malzemeler San. ve Tic. A.S.

Collaborator

Source ClinicalTrials.gov