Evaluation of 3D Metal Cones in Knee Replacement
A Post-Market, Retrospective Study to Collect Clinical Outcomes From Patients Who Have Undergone Revision Total Knee Arthroplasty Using Medacta GMK Revision With 3D Metal Tibial and Femoral Cones.
This study looks at how well 3D metal cones used in knee replacement surgery work for people with conditions like osteoarthritis and rheumatoid arthritis who had their surgery at least a year ago.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | Medacta International SA Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06578897 on ClinicalTrials.gov |
What this trial studies
This observational study examines the outcomes of patients who underwent revision total knee arthroplasty using the Medacta GMK Revision Knee System, specifically focusing on the 3D metal tibial and femoral cones. The study aims to assess the performance and effectiveness of these components in patients with various underlying conditions such as osteoarthritis and rheumatoid arthritis. Participants must be at least one year post-treatment to evaluate long-term results. The study will analyze data retrospectively to determine the success and complications associated with this knee replacement system.
Who should consider this trial
Good fit: Ideal candidates include individuals who have undergone revision total knee replacement with the Medacta GMK Revision component and are at least one year post-treatment.
Not a fit: Patients with neuromuscular deficiencies or those undergoing chemotherapy or radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of 3D metal cones in improving knee replacement outcomes.
How similar studies have performed: While this approach is observational, similar studies on advanced knee replacement technologies have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Chicago, Illinois
- Northwestern — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Rena Mandino
- Email: rmandino@medacta.us.com
- Phone: 312-244-0232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.