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NCT06578897 · ClinicalTrials.gov registry record
A Post-Market, Retrospective Study on 3D Metal Tibial and Femoral Cones
A clinical trial of Total Knee Arthroplasty, sponsored by Medacta International.
- Completed
- Registry status
- 118
- Enrollment target
- 1
- Study location
NCT06578897 is a study of Total Knee Arthroplasty that has completed, run by Medacta International. The registered enrollment target is 118 participants, below the 291-participant average among 29 other Total Knee Arthroplasty trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06578897, a study of Total Knee Arthroplasty, has completed, sponsored by Medacta International.
- COMPLETED
- Registry status
- 118 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 291-participant average among 29 other Total Knee Arthroplasty trials with a reported enrollment target (59% lower). The listed sponsor is Medacta International, which has 2 total studies on file at ClinicalTrials.gov.
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.
NCT06578897 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
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.
What interventions are being tested in trial NCT06578897?
The interventions under investigation include: 3D Metal Tibial and Femoral cones (DEVICE).
Who is sponsoring clinical trial NCT06578897?
This trial is sponsored by Medacta International, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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Related
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