Spine Bone Cements Outcomes - Post Market Follow-up
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTeknimed
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Vertebroplasty (VP)
- Kyphoplasty (KP)
- Pedicular Screw Augmentation (PSA)
Treatment groups
500 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov