Clinical Research Directory
Browse clinical research sites, groups, and studies.
Spine Bone Cements Outcomes - Post Market Follow-up
Sponsor: Teknimed
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
Vertebroplasty (VP)
Vertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
Kyphoplasty (KP)
Kyphoplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
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