Actively Recruiting
Spine Bone Cements Outcomes - Post Market Follow-up
Led by Teknimed · Updated on 2025-09-09
500
Participants Needed
12
Research Sites
1047 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Spine Bone Cements Outcomes - Post Market Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years or older
- Be willing to sign an informed consent approved by Ethic Committee (when applicable) or not be opposed to use of clinical data
- For prospective inclusion: considered for treatment with one of the TEKNIMED Spine Range cements in this study
- For retrospective inclusion: have undergone surgery with a TEKNIMED Spine Range cement since January 1, 2016, and not oppose use of clinical data or be willing to sign informed consent at first follow-up (when applicable)
You will not qualify if you...
- Procedures other than those stated in the indications
- Coagulation disorders or severe cardiopulmonary disease
- Unstable vertebral fractures
- Compromise of the vertebral body or pedicle walls
- Hypersensitivity or allergy to any constituents of the product
- Patient clearly improving with more conservative treatment
- Prophylactic use in spinal metastatic or osteoporotic patients without evidence of acute fracture
- Pediatric patients
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
CHU HautePierre
Strasbourg, Bas-Rhin, France, 67200
Actively Recruiting
2
Pôle Rachis Hôpital Privé d'Eure et Loir
Mainvilliers, Eure et Loir, France, 28300
Actively Recruiting
3
Hôpital Toulouse Purpan
Toulouse, Haute Garonne, France, 31130
Actively Recruiting
4
Pôle Sud Santé
Le Mans, Sarthe, France, 72100
Actively Recruiting
5
Centre Hospitalier Métropole Savoie
Chambéry, Savoie, France, 73000
Actively Recruiting
6
Hospitale Cruz Vermelha Portuguesa
Lisbon, Portugal, 1549-008
Actively Recruiting
7
Clínica Teknon Instituto de neurociencias
Barcelona, Spain, 08022
Actively Recruiting
8
Hospital Neurotraumatologico
Granada, Spain, 18013
Actively Recruiting
9
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Actively Recruiting
10
Fundacio Assistencial Mutua de Terrassa - Edifici Estació
Terrassa, Spain, 08222
Actively Recruiting
11
Hospital de Zafra
Zafra, Spain, 06300
Actively Recruiting
12
Institute of Traumatology and Orthopaedics
Kiev, Ukraine, 1601
Actively Recruiting
Research Team
S
Solange VAN DE MOORTELE, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
9
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