An observational study in Vertebral Fracture, Compression Fracture and Osteoporotic Fractures, sponsored by Teknimed. Recruiting at 12 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Teknimed · Observational
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.
It is admitted that:
TEKNIMED has developed several bone cements currently used in vertebroplasty and kyphoplasty procedures in the treatment of vertebral weakness. Among those, one cement is also used in pedicle screw augmentation procedures.
With the increasing use of these procedures, there is a need of real-life safety and efficacy data on the bone cements.
This retro-prospective study is performed to confirm the safety and performance of TEKNIMED spine bone cements in their current clinical use.
144 studies on the registry are indexed under Spinal Fractures; 24 are open to participants now.
This study's planned enrollment of 500 is above the median of 93 across 55 observational studies indexed under Spinal Fractures.
Browse Spinal Fractures studies →Teknimed is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients suffering from painful vertebral compression fractures resulting from osteoporosis, benign or malignant lesions, or of traumatic origin
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Be willing to sign an approved by Ethic Committee (when applicable) or not being opposed to the use of their clinical data in the study
o For prospective inclusion:
Be considered for treatment with one of the TEKNIMED Spine Range cement comprised in this study
o For retrospective inclusion:
Exclusion Criteria:
Patients presenting one of the following conditions will not be included ( per IFU):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vertebroplasty
Device: Vertebroplasty (VP)
Kyphoplasty
Device: Kyphoplasty (KP)
Vertebroplasty
Device: Vertebroplasty (VP)
Kyphoplasty
Device: Kyphoplasty (KP)
Pedicular Screw Augmentation
Device: Pedicular Screw Augmentation (PSA)
Vertebroplasty
Device: Vertebroplasty (VP)
Kyphoplasty
Device: Kyphoplasty (KP)
Vertebroplasty
Device: Vertebroplasty (VP)
Kyphoplasty
Device: Kyphoplasty (KP)
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
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
Time frame: 24 months
Restoration of quality of life
Evaluated through short questions : Oswestry Disability Index (ODI score)
Time frame: 24 months
Patient satisfaction
Evaluated through short questions : A. Are you satisfied with your surgery? Yes/No/Without opinion B. Has your health improved? Yes/Stable/No C. Given the results, would you accept this intervention again? Yes/No/Without opinion
Time frame: 24 months
Stabilization of vertebrae
Radiographic imaging
Time frame: 24 months
Adverse events
All adverse events occured during surgery and through study completion
Time frame: 10 years
Antalgic Consumption
Antalgic consumption and the drug type at the Baseline and at the Follow-up visits
Time frame: 24 months
Plan to share: No
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