A Post-Market, Retrospective Study on 3D Metal Tibial and Femoral Cones
NCT Number: NCT06578897
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Total Knee Arthroplasty
Interventions: DEVICE: 3D Metal Tibial and Femoral cones
Sponsor: Medacta International SA
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-13
Completion Date: 2025-12-13
Locations: Northwestern, Chicago, Illinois, 60611, United States

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 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.

Primary Outcome Measures: To collect retrospective clinical outcomes and data on revision TKAs using Medacta GMK Revision with 3D metal tibial and femoral cones, Oxford Knee Score (OKS) is a 12-item patient-reported PRO specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty).

The overall score for the OKS is acquired by simply summing the scores received for individual questions. This results in a continuous score ranging from 0 (most severe symptoms/problems) to 48 (least severe)., 1 year|To collect retrospective clinical outcomes and data on revision TKAs using Medacta GMK Revision with 3D metal tibial and femoral cones, Forgotten Joint Score (FJS) is a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint.

The FJS responses "never," "almost never," "seldom," "sometimes," and "mostly" translate into a 5-point Likert-response format translated linearly into a summative range from 0 to 100 scale with high values translating to the patient successfully "forgetting" about their joint during activities of daily living, 1 year|To collect retrospective clinical outcomes and data on revision TKAs using Medacta GMK Revision with 3D metal tibial and femoral cones, Knee Injury and Osteoarthritis Outcome Score (KOOS) s a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury.

Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures., 1 year
Secondary Outcome Measures: Evaluate the clinical and radiological performance, standard x-ray exam performed preoperatively and postoperatively before discharge from hospital and during follow-up visits, 1 year|Evaluate safety of the cones, Any complication occurred during the study, through study completion, an average of 1 year|Evaluate survivorship of revisions using tibial and femoral cones, % survival rate, 1 year