Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367582
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-11
Brief Title:
Spine Bone Cements Outcomes - Post Market Follow-up
Sponsor:
Teknimed
Organization:
Teknimed
Study Overview
Official Title:
Safety and Clinical Performance Assessment of Bone Cements and Injection Systems Used in Spine Surgery - A Post-Market Clinical Follow-Up
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
It is admitted that
Cementoplasty procedures such as vertebroplasty and kyphoplasty are recommended in the treatment of painful vertebral compression fractures due to their efficiency and safety
These mini-invasive procedures where bone cement is injected into a partially collapsed vertebral body are used to reduce pain and to provide mechanical stability
In most patients a rapid pain relief and an increase in mobility and quality of life are obtained
Serious complications from bone cements leaks and adjacent vertebral fractures can be observed but remain rather rare
The use of spinal cement in pedicle screw augmentation procedures can be relevant to increase the strength of the screw fixation in the bone particularly in osteoporotic patients
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
Cementoplasty procedures such as vertebroplasty and kyphoplasty are recommended in the treatment of painful vertebral compression fractures due to their efficiency and safety
These mini-invasive procedures where bone cement is injected into a partially collapsed vertebral body are used to reduce pain and to provide mechanical stability
In most patients a rapid pain relief and an increase in mobility and quality of life are obtained
Serious complications from bone cements leaks and adjacent vertebral fractures can be observed but remain rather rare
The use of spinal cement in pedicle screw augmentation procedures can be relevant to increase the strength of the screw fixation in the bone particularly in osteoporotic patients
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None