A Post-Market, Retrospective Study on 3D Metal Tibial and Femoral Cones

Launched by MEDACTA INTERNATIONAL SA · Aug 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a special type of knee replacement called the GMK Revision Knee System, which is designed for patients who need a second surgery after a previous knee replacement has failed or when there is significant bone loss. The trial focuses on using advanced 3D metal cones that provide extra support to the knee joint, helping to improve stability and function. It aims to gather information about how well these components work for patients who have had various types of knee problems, including arthritis and previous surgery failures.

To be eligible for this study, participants must have undergone a revision total knee replacement using the GMK Revision system and must be at least one year post-surgery. There are some exclusions, such as individuals with certain health conditions that could affect the study results. If you qualify, you can expect to share your experiences after your knee surgery, which will help researchers understand the effectiveness of this new technology in supporting people with knee issues.

Gender

ALL

Eligibility 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