Spine Bone Cements Outcomes - Post Market Follow-up
Safety and Clinical Performance Assessment of Bone Cements and Injection Systems Used in Spine Surgery - A Post-Market Clinical Follow-Up
1 other identifier
observational
500
4 countries
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 4, 2019
CompletedFirst Submitted
Initial submission to the registry
April 11, 2024
CompletedFirst Posted
Study publicly available on registry
April 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2039
September 9, 2025
September 1, 2025
10 years
April 11, 2024
September 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Alleviation of Pain
Pain evaluated by Visual Analogue Scale (VAS): on a scale of 0 to 10, with 0 being no pain and 10 being the most severe pain at the Baseline and at the Follow-up visits
24 months
Secondary Outcomes (5)
Restoration of quality of life
24 months
Patient satisfaction
24 months
Stabilization of vertebrae
24 months
Adverse events
10 years
Antalgic Consumption
24 months
Study Arms (9)
F20 VP
Vertebroplasty
F20 KP
Kyphoplasty
SPINEFIX VP
Vertebroplasty
SPINEFIX KP
Kyphoplasty
SPINEFIX PSA
Pedicular Screw Augmentation
HIGH V+ VP
Vertebroplasty
HIGH V+ KP
Kyphoplasty
OPACITY+ VP
Vertebroplasty
OPACITY+ KP
Kyphoplasty
Interventions
Vertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
Kyphoplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
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
Eligibility Criteria
Adult patients suffering from painful vertebral compression fractures resulting from osteoporosis, benign or malignant lesions, or of traumatic origin
You may qualify if:
- Be 18 years or older
- Be willing to sign an informed consent approved by Ethic Committee (when applicable) or not being opposed to the use of their clinical data in the study
- Be considered for treatment with one of the TEKNIMED Spine Range cement comprised in this study
- Have undergone a surgery with a TEKNIMED Spine Range cement between the 1st of January 2016 and the date of the site initiation visit.
- Be informed of the study and not being opposed to the use of their clinical data in the study or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable).
You may not qualify if:
- Patients presenting one of the following conditions will not be included (contraindications per IFU):
- Procedures other than those stated in the INDICATIONS section
- Coagulation disorders, or severe cardiopulmonary disease
- Unstable vertebral fractures
- Compromise of the vertebral body or of the pedicle walls
- Hypersensitivity or allergy to one of the constituents of the product
- Patient clearly improving on more conservative treatment
- Prophylactic use in spinal metastatic or osteoporotic patients with no evidence of acute fracture
- Paediatric patients and pregnant or breast-feeding women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teknimedlead
Study Sites (12)
CHU HautePierre
Strasbourg, Bas-Rhin, 67200, France
Pôle Rachis Hôpital Privé d'Eure et Loir
Mainvilliers, Eure et Loir, 28300, France
Hôpital Toulouse Purpan
Toulouse, Haute Garonne, 31130, France
Pôle Sud Santé
Le Mans, Sarthe, 72100, France
Centre Hospitalier Métropole Savoie
Chambéry, Savoie, 73000, France
Hospitale Cruz Vermelha Portuguesa
Lisbon, 1549-008, Portugal
Clínica Teknon Instituto de neurociencias
Barcelona, 08022, Spain
Hospital Neurotraumatologico
Granada, 18013, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120, Spain
Fundacio Assistencial Mutua de Terrassa - Edifici Estació
Terrassa, 08222, Spain
Hospital de Zafra
Zafra, 06300, Spain
Institute of Traumatology and Orthopaedics
Kiev, 1601, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2024
First Posted
April 16, 2024
Study Start
September 4, 2019
Primary Completion (Estimated)
September 4, 2029
Study Completion (Estimated)
September 30, 2039
Last Updated
September 9, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share