Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578897
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
A Post-Market Retrospective Study on 3D Metal Tibial and Femoral Cones
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Post-Market Retrospective Study to Collect Clinical Outcomes From Patients Who Have Undergone Revision Total Knee Arthroplasty Using Medacta GMK Revision With 3D Metal Tibial and Femoral Cones
Status:
RECRUITING
Status Verified Date:
2024-08
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:
GMK Revision Knee System is part of the Medacta GMK Global Medacta Knee Total Knee System and is indicated when a higher level of varusvalgus constraint is needed The external shape of the GMK Revision femoral component is identical to that of GMK Primary The GMK Revision differs from GMK Primary by three important design features
i The addition of a box which allows a stem to be inserted into the femoral canal ii The addition of screw lugs so that augments can be placed on the distal and posterior resections and iii The box which also allows various levels of constraint to be added to the polyethylene insert The tibial component offers the ability to place augments
Indications for Use
The GMK Total Knee System is designed for cemented use in total knee arthroplasty if there is evidence of sufficient sound bone to seat and support the components
This knee replacement system is indicated in the following cases
Severely painful andor disabled joint as a result of arthritis traumatic arthritis rheumatoid arthritis or polyarthritis
Avascular necrosis of femoral condyle
Post traumatic loss of joint configuration
Primary implantation failure
Ligamentous Instability
Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement In case a semi-constrained liner is used an extension stem must be implanted both on the tibial and on the femoral component
GMK Revision femoral components are manufactured of Cobalt Chromium Molybdenum CoCrMo according to ISO 5832-41996 Implants for Surgery- Metallic materials - Part 4 Cobalt-Chromium-Molybdenum Casting Alloy the same as the GMK Primary femoral components They have an asymmetric patellar groove left and right with different radii of curvature in coronal plane as well as non-parallel anterior and posterior cuts wedge shape The GMK Revision posterior stabilized femoral components are designed for use without cruciate ligaments when additional stability is required to prevent subluxation of the femur to the tibia in flexion same as the GMK Primary femoral components
In case of severe bone loss the tibial cones and femoral cones may be used to respectively reinforce the proximal tibia cavity and the distal femoral cavity providing structural support and load redistribution on the remaining bone Being an integral part of revision TKA for patients with such bone loss the clinical outcomes for revision TKAs using the cone components are important for the knowledge regarding performance and survivorship of the Revision TKA as a whole
i The addition of a box which allows a stem to be inserted into the femoral canal ii The addition of screw lugs so that augments can be placed on the distal and posterior resections and iii The box which also allows various levels of constraint to be added to the polyethylene insert The tibial component offers the ability to place augments
Indications for Use
The GMK Total Knee System is designed for cemented use in total knee arthroplasty if there is evidence of sufficient sound bone to seat and support the components
This knee replacement system is indicated in the following cases
Severely painful andor disabled joint as a result of arthritis traumatic arthritis rheumatoid arthritis or polyarthritis
Avascular necrosis of femoral condyle
Post traumatic loss of joint configuration
Primary implantation failure
Ligamentous Instability
Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement In case a semi-constrained liner is used an extension stem must be implanted both on the tibial and on the femoral component
GMK Revision femoral components are manufactured of Cobalt Chromium Molybdenum CoCrMo according to ISO 5832-41996 Implants for Surgery- Metallic materials - Part 4 Cobalt-Chromium-Molybdenum Casting Alloy the same as the GMK Primary femoral components They have an asymmetric patellar groove left and right with different radii of curvature in coronal plane as well as non-parallel anterior and posterior cuts wedge shape The GMK Revision posterior stabilized femoral components are designed for use without cruciate ligaments when additional stability is required to prevent subluxation of the femur to the tibia in flexion same as the GMK Primary femoral components
In case of severe bone loss the tibial cones and femoral cones may be used to respectively reinforce the proximal tibia cavity and the distal femoral cavity providing structural support and load redistribution on the remaining bone Being an integral part of revision TKA for patients with such bone loss the clinical outcomes for revision TKAs using the cone components are important for the knowledge regarding performance and survivorship of the Revision TKA as a whole
Detailed Description:
None
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