Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532929
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Sport Surgery Products Outcomes - A Post-market Follow-up
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Clinical Performance Assessment of Sport Surgery Products - A Post-market Clinical Follow-up
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Teknimed is currently conducting a post-market clinical follow-up which will confirm performance safety and usability for all the Teknimed range of Sports products TEKNIMED has developed several devices currently used in orthopaedic surgery With the increasing use of these procedures there is a need for real-life long-term safety and efficacy data on these products
The study is a retrospective and prospective global single arm non-controlled multicentric ambispective observational study Patients will be followed as per local standard medical care of the site
The study is a retrospective and prospective global single arm non-controlled multicentric ambispective observational study Patients will be followed as per local standard medical care of the site
Detailed Description:
It is admitted that
Bioabsorbable interference screws are frequently used for graft attachment in knee cruciate ligament reconstruction
Bioabsorbable pins are indicated for the realignment and fixation of epiphyseal fractures osteotomies arthrodesis and bone grafts of toes
Non-absorbable suture is usually used for the repair and the reinforcement of ligaments or tendons structures during surgery procedures
Anchor devices are usually used for the repair of rotator cuff tendons and biceps tenodesis
Furthermore resorption properties of many available devices screws pins that are marketed as bioabsorbable may be different and not always very well defined
This retro-prospective study is performed to confirm the safety and performance of TEKNIMED sports surgery products in their current clinical use
Studied products include - but are not restricted to - the following TEKNIMED products
EUROSCREW
EUROSCREW NG
ISOFIX
SUTURLINK
ALINKS
BIORESORBABLE PINS
And following associated TEKNIMED instrumentation
ACL Instrumentation
ALINKS Instrumentation
STAINLESS STEEL PINS
Bioabsorbable interference screws are frequently used for graft attachment in knee cruciate ligament reconstruction
Bioabsorbable pins are indicated for the realignment and fixation of epiphyseal fractures osteotomies arthrodesis and bone grafts of toes
Non-absorbable suture is usually used for the repair and the reinforcement of ligaments or tendons structures during surgery procedures
Anchor devices are usually used for the repair of rotator cuff tendons and biceps tenodesis
Furthermore resorption properties of many available devices screws pins that are marketed as bioabsorbable may be different and not always very well defined
This retro-prospective study is performed to confirm the safety and performance of TEKNIMED sports surgery products in their current clinical use
Studied products include - but are not restricted to - the following TEKNIMED products
EUROSCREW
EUROSCREW NG
ISOFIX
SUTURLINK
ALINKS
BIORESORBABLE PINS
And following associated TEKNIMED instrumentation
ACL Instrumentation
ALINKS Instrumentation
STAINLESS STEEL PINS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None