The Medacta GMK SpheriKA Post-Marketing Surveillance Study

Launched by MEDACTA INTERNATIONAL SA · Jul 12, 2022

Keywords

ClinConnect Summary

The Medacta GMK SpheriKA Post-Marketing Surveillance Study is a research trial looking at a specific type of knee replacement device called the GMK SpheriKA. This study aims to gather information on how well this knee prosthesis works in real-life situations after it has been approved for use. The trial is currently recruiting participants who are between 18 and 80 years old and need a total knee replacement due to knee problems, such as arthritis. To join the study, patients must be able to follow post-surgery guidelines, including certain weight-bearing restrictions and completing self-evaluations.

Participants in this trial will be monitored after their knee surgery to see how the device performs and to ensure their recovery is on track. However, there are some criteria that could prevent someone from joining, such as having certain health conditions like inflammatory arthritis, being significantly overweight, or having had previous knee surgeries. If you are considering participation, it's important to discuss any concerns with your healthcare provider to see if this study is right for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients willing to sign the informed consent.
• • Patients able to comply with follow-up requirements, including postoperative weight-bearing restrictions and self-evaluations.
• • Patients 18 - 80 years of age at the time of surgery.
• • Patients requiring a primary total knee replacement (on label use).
• • Patients with intact collateral ligaments.
• Exclusion Criteria:
• • Patients with inflammatory arthritis.
• • Morbidly obese patients, with a body mass index (BMI) \> 40.
• • Patients with a history of total or unicompartmental reconstruction of the affected joint.
• • Patients that have had a high tibial osteotomy or femoral osteotomy.
• • Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
• • Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
• • Patients that are immunologically compromised or receiving chronic steroids (\> 30 days).
• • Patients whose bone stock is compromised due to disease or infection, unable to provide adequate support and/or fixation to the prosthesis.
• • Patients with an active or suspected latent infection in or surrounding the knee joint.
• • Pregnant or breastfeeding women.