The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

Launched by MEDACTA INTERNATIONAL SA · Aug 6, 2021

Keywords

ClinConnect Summary

The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study is looking at a specific type of knee implant called the GMK Sphere cementless prosthesis. This study is important because it helps gather information about how well this implant works for patients who have severe arthritis or related conditions and are scheduled for total knee replacement surgery. The goal is to see how this new implant performs in a real-world setting after it has been made available to patients.

To be eligible for this study, participants need to be between 18 and 80 years old and must have a severely disabled knee joint due to arthritis or similar issues. They should also be able to give their consent to participate. However, there are certain conditions that would exclude someone from the study, such as having an active infection or other serious health problems that could affect recovery. If you decide to participate, you can expect to undergo the knee replacement surgery and will be monitored for how well the implant works over time. This study is currently recruiting participants, and anyone interested should talk to their healthcare provider for more details.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis
• • Patients between the age of 18 and 80 at the time of consent
• • Listed for total knee replacement surgery.
• • Patients who are willing and able to give informed written consent
• Exclusion Criteria:
• • Progressive local or systemic infection
• • Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable
• • Severe instability secondary to advance destruction of condralar structures or loss of integrity of the medial or lateral ligament
• • Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
• • Patient whose BMI exceeds 40
• • Any case not described in the inclusion criteria