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RECRUITING
NCT06374342

Bone Substitutes Outcomes - Post Market Follow-up

Sponsor: Teknimed

View on ClinicalTrials.gov

Summary

A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Bone Substitute range of products: CERAFORM, TRIHA+, NANOGEL, and all their private labels. TEKNIMED bone substitutes are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting. The study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites.

Official title: Safety and Clinical Performance Assessment of Bone Substitutes Used for Bone Voids Filling - A Post-Market Clinical Follow-Up

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

425

Start Date

2021-09-16

Completion Date

2032-09-30

Last Updated

2025-09-09

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Bone defect

Bone grafting is a procedure where damaged bones can be repaired or rebuilt using transplanted bone from another source. Sources for transplant bone include the patient (autograft), a cadaver (allograft) or synthetic bone.

DEVICE

Spine fusion

Spinal fusion is a surgery procedure that reinforces your back structure and stability by linking two vertebrae together

DEVICE

Cage filling

Intervertebral fusion with cages is a surgical procedure used to stabilize the spine by fusing adjacent vertebrae. The cages, typically made of materials like titanium or plastic, and pre-filled with bone graft substitutes are placed between the vertebrae to maintain the proper spacing and alignment.

Locations (6)

Pôle Rachis Hôpital Privé d'Eure et Loir

Mainvilliers, Eure et Loir, France

Hôpital Joseph Ducuing

Toulouse, Haute Garonne, France

Clinique Médipole Garonne

Toulouse, Haute Garonne, France

CHRU Brabois

Nancy, Meurthe et Moselle, France

Clinique du Pré

Le Mans, Sarthe, France

OCM Klinik GmbH

München, Bavaria, Germany