Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379321
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-04-18
Brief Title:
Evaluation of Outcomes of the Triathlon Hinge Knee THK System
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A RetrospectiveProspective Post-market Multi-center Evaluation of the Clinical Outcomes of the Triathlon Hinge Knee THK System
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Hinge
Brief Summary:
This study is a prospectively and retrospectively enrolled post-market open-label non-randomized single institution evaluation of clinical outcomes of primary or revision knee surgery patients who meet the eligibility criteria and received devices from the Triathlon Hinge Knee System according to its indications for use IFU
Clinical evaluation for all cases will include data collection of patient demographics surgical details early postoperative status functional and clinical outcomes and survivorship at 1 2 6 and 10-years
Clinical evaluation for all cases will include data collection of patient demographics surgical details early postoperative status functional and clinical outcomes and survivorship at 1 2 6 and 10-years
Detailed Description:
The purpose of this study is to evaluate the safety and performance of the Triathlon Hinge Knee System for both primary and revision cases in accordance with the Indications for Use
The main objective of this study is to determine 1 mid- 5 year and long-term 10 year survivorship and 2 drivers of failure for the THK hinge Data from this study will be used to develop a predictive model to identify the most important factors in achieving fixation including the role of augments cones thresholds for cement mantle thickness and number of zones of fixation required for survivorship
Survivorship is defined as the absence of aseptic revision to the implanted device
The Triathlon Hinge Knee System consists of Triathlon Hinge femoral components the Triathlon Revision baseplate Triathlon Revision Tibial Augments Triathlon Hinge Femoral Distal Augments Triathlon Hinge Insert Triathlon Revision Insert X3 and Triathlon Hinge Bumpers Axle Bushings Tibial Sleeve and Bearing component
It is designed to be a single platform for revision difficult primary and limb salvage surgeries
The main objective of this study is to determine 1 mid- 5 year and long-term 10 year survivorship and 2 drivers of failure for the THK hinge Data from this study will be used to develop a predictive model to identify the most important factors in achieving fixation including the role of augments cones thresholds for cement mantle thickness and number of zones of fixation required for survivorship
Survivorship is defined as the absence of aseptic revision to the implanted device
The Triathlon Hinge Knee System consists of Triathlon Hinge femoral components the Triathlon Revision baseplate Triathlon Revision Tibial Augments Triathlon Hinge Femoral Distal Augments Triathlon Hinge Insert Triathlon Revision Insert X3 and Triathlon Hinge Bumpers Axle Bushings Tibial Sleeve and Bearing component
It is designed to be a single platform for revision difficult primary and limb salvage surgeries
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None