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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vertebroplasty (VP) | Device | Vertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Restoration of quality of life | Evaluated through short questions : Oswestry Disability Index (ODI score) | 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 |
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Inclusion Criteria:
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
o For prospective inclusion:
Be considered for treatment with one of the TEKNIMED Spine Range cement comprised in this study
o For retrospective inclusion:
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).
Exclusion Criteria:
Patients presenting one of the following conditions will not be included (contraindications per IFU):
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Adult patients suffering from painful vertebral compression fractures resulting from osteoporosis, benign or malignant lesions, or of traumatic origin
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Solange VAN DE MOORTELE, PhD | Contact | +33534252679 | s.vandemoortele@teknimed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU HautePierre | Recruiting | Strasbourg | Bas-Rhin | 67200 | France |
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| ID | Term |
|---|---|
| D016103 | Spinal Fractures |
| D050815 | Fractures, Compression |
| D058866 | Osteoporotic Fractures |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D054854 | Vertebroplasty |
| D058498 | Kyphoplasty |
| ID | Term |
|---|---|
| D060826 | Cementoplasty |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| OPACITY+ VP | Vertebroplasty |
|
| OPACITY+ KP | Kyphoplasty |
|
| Kyphoplasty (KP) | Device | 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) | Device | 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 |
|
| 24 months |
| Stabilization of vertebrae | Radiographic imaging | 24 months |
| Adverse events | All adverse events occured during surgery and through study completion | 10 years |
| Antalgic Consumption | Antalgic consumption and the drug type at the Baseline and at the Follow-up visits | 24 months |
| Pôle Rachis Hôpital Privé d'Eure et Loir | Recruiting | Mainvilliers | Eure et Loir | 28300 | France |
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| Hôpital Toulouse Purpan | Recruiting | Toulouse | Haute Garonne | 31130 | France |
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| Pôle Sud Santé | Recruiting | Le Mans | Sarthe | 72100 | France |
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| Centre Hospitalier Métropole Savoie | Recruiting | Chambéry | Savoie | 73000 | France |
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| Hospitale Cruz Vermelha Portuguesa | Recruiting | Lisbon | 1549-008 | Portugal |
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| Clínica Teknon Instituto de neurociencias | Recruiting | Barcelona | 08022 | Spain |
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| Hospital Neurotraumatologico | Recruiting | Granada | 18013 | Spain |
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| Hospital Clínico Universitario Virgen de la Arrixaca | Recruiting | Murcia | 30120 | Spain |
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| Fundacio Assistencial Mutua de Terrassa - Edifici Estació | Recruiting | Terrassa | 08222 | Spain |
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| Hospital de Zafra | Recruiting | Zafra | 06300 | Spain |
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| Institute of Traumatology and Orthopaedics | Recruiting | Kiev | 1601 | Ukraine |
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