NCT06578897

A Post-Market, Retrospective Study on 3D Metal Tibial and Femoral Cones

Completed Last updated 29 September 2025

What this trial tests

trial testing 3D Metal Tibial and Femoral cones in Total Knee Arthroplasty in 118 participants. Completed in 13 February 2025.

Timeline

13 February 2024

Primary endpoint
13 February 2025

13 February 2025

Quick facts

Lead sponsor	Medacta International SA
Status	Completed
Study type	OBSERVATIONAL
Enrollment	118
Start date	13 February 2024
Primary completion	13 February 2025
Estimated completion	13 February 2025
Sites	1 location across United States

Drugs / interventions tested

• 3D Metal Tibial and Femoral cones

Conditions studied

• Total Knee Arthroplasty — all drugs for Total Knee Arthroplasty →

Sponsor

Medacta International SA — full company profile →

Who can join

Eligibility, any sex, with Total Knee Arthroplasty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

GMK Revision Knee System is part of the Medacta GMK® (Global Medacta Knee) Total Knee System and is indicated when a higher level of varus/valgus 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 and/or 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 5832-4:1996, 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.