Status:
COMPLETED
A Post-Market, Retrospective Study on 3D Metal Tibial and Femoral Cones
Lead Sponsor:
Medacta International SA
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
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 varus/valgus constraint is needed. The external shape of the GMK® R...
Eligibility Criteria
Inclusion
- Subjects underwent revision total knee replacement for any type of etiology (Osteoarthritis, Avascular necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Polyarthritis, Primary implantation failure, Infection, Ligamentous Instability)
- Subjects must have received a Medacta GMK Revision component using 3D metal tibial and femoral cones
- Must be at minimum 1 year (12 months) post-treatment
- No age limit criteria
Exclusion
- Subjects with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device
- Subjects that were incarcerated at the time of surgery.
- History of alcoholism
- On chemotherapy or radiation therapy during the time of interest
- Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than knee pain
- History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
- History of chronic pain issues for reasons other than knee pain
- Progressive local or systemic infection during time of interest
- Muscular loss, neuromuscular disease, or vascular deficiency of the affected limb
- Obesity or excessive weight of subject
Key Trial Info
Start Date :
February 13 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 13 2025
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT06578897
Start Date
February 13 2024
End Date
February 13 2025
Last Update
September 29 2025
Active Locations (1)
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1
Northwestern
Chicago, Illinois, United States, 60611