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A Post-Market, Retrospective Study on 3D Metal Tibial and Femoral Cones
NCT06578897 · View on ClinicalTrials.gov ↗
Study 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 whe
Conditions Studied
Interventions
- DEVICE 3D Metal Tibial and Femoral cones
Study Locations (1)
Illinois
- Northwestern — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2024-02-13 |
| Est. Completion | 2025-02-13 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06578897
The ClinicalTrials.gov registry entry for NCT06578897 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medacta International, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Total Knee Arthroplasty appearing as the primary indexed condition, and to 1 intervention — of which 3D Metal Tibial and Femoral cones is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06578897 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06578897 about?
NCT06578897 is a clinical study titled "A Post-Market, Retrospective Study on 3D Metal Tibial and Femoral Cones". 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® ...
What is the current status of trial NCT06578897?
This trial is currently completed. The enrollment target is 118 participants. The study started on 2024-02-13. Estimated completion is 2025-02-13.
What conditions does trial NCT06578897 study?
This clinical trial studies the following conditions: Total Knee Arthroplasty. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06578897?
The interventions under investigation include: 3D Metal Tibial and Femoral cones (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06578897?
This trial is sponsored by Medacta International, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06578897 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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