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RECRUITING
NCT06367582

Spine Bone Cements 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 Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels. TEKNIMED bone cements are legacy products, some marketed for more than 10 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 Cements and Injection Systems Used in Spine Surgery - A Post-Market Clinical Follow-Up

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2019-09-04

Completion Date

2039-09-30

Last Updated

2025-09-09

Healthy Volunteers

No

Interventions

DEVICE

Vertebroplasty (VP)

Vertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain

DEVICE

Kyphoplasty (KP)

Kyphoplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain

DEVICE

Pedicular Screw Augmentation (PSA)

Pedicular Screw Augmentation is a procedure in which a special medical-grade cement mixture is injected into pedicular screws in order to augment fixation strength

Locations (12)

CHU HautePierre

Strasbourg, Bas-Rhin, France

Pôle Rachis Hôpital Privé d'Eure et Loir

Mainvilliers, Eure et Loir, France

Hôpital Toulouse Purpan

Toulouse, Haute Garonne, France

Pôle Sud Santé

Le Mans, Sarthe, France

Centre Hospitalier Métropole Savoie

Chambéry, Savoie, France

Hospitale Cruz Vermelha Portuguesa

Lisbon, Portugal

Clínica Teknon Instituto de neurociencias

Barcelona, Spain

Hospital Neurotraumatologico

Granada, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Fundacio Assistencial Mutua de Terrassa - Edifici Estació

Terrassa, Spain

Hospital de Zafra

Zafra, Spain

Institute of Traumatology and Orthopaedics

Kiev, Ukraine