Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374342
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-16
Brief Title:
Bone Substitutes Outcomes - Post Market Follow-up
Sponsor:
Teknimed
Organization:
Teknimed
Study Overview
Official Title:
Safety and Clinical Performance Assessment of Bone Substitutes Used for Bone Voids Filling - 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 Bone Substitute range of products CERAFORM TRIHA NANOGEL and all their private labels
TEKNIMED bone substitutes are legacy products some marketed for more than 20 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 substitutes are legacy products some marketed for more than 20 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
Surgeons are often concerned by bone void filling and they can choose between synthetic bone substitutes or bone grafts of animal or human origin
Due to their chemical composition similar to bone tissue synthetic bone substitutes are an interesting alternative to autografts and allografts which present some inconvenient quantity to sample infection of sampling site
Bone substitutes are bioresorbable and replaced by bone during the healing process bone remodelling
Nowadays bone substitutes represent a common and efficient procedure to treat surgical or traumatic osseous defects They are indicated and used in various pathologies and types of surgery but they always have the same intended use to fill a bone void
Bone substitutes are also used in spine surgeries for cage filling andor posterolateral fusion
TEKNIMED has developed several bone substitutes currently used in various types of surgery Due to their increasing use there is a need of real-life safety and efficacy data on these products
This retro-prospective study is performed to assess the safety and performance of TEKNIMED bone substitutes in their current clinical use
Surgeons are often concerned by bone void filling and they can choose between synthetic bone substitutes or bone grafts of animal or human origin
Due to their chemical composition similar to bone tissue synthetic bone substitutes are an interesting alternative to autografts and allografts which present some inconvenient quantity to sample infection of sampling site
Bone substitutes are bioresorbable and replaced by bone during the healing process bone remodelling
Nowadays bone substitutes represent a common and efficient procedure to treat surgical or traumatic osseous defects They are indicated and used in various pathologies and types of surgery but they always have the same intended use to fill a bone void
Bone substitutes are also used in spine surgeries for cage filling andor posterolateral fusion
TEKNIMED has developed several bone substitutes currently used in various types of surgery Due to their increasing use there is a need of real-life safety and efficacy data on these products
This retro-prospective study is performed to assess the safety and performance of TEKNIMED bone substitutes 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