GMK Sphere TiNb Total Knee Arthroplasty PMS Study

Launched by MEDACTA INTERNATIONAL SA · Mar 16, 2021

Keywords

ClinConnect Summary

The GMK Sphere TiNb Total Knee Arthroplasty PMS Study is researching a new type of knee implant designed to help patients who need total knee replacement surgery. This study focuses on a specific coating called TiNbN, which may reduce the risk of complications related to metal implants. Researchers want to see how well this coated implant performs over the long term compared to traditional metal implants. They are looking for participants aged 18 and older who are scheduled for knee replacement surgery and are suitable for this specific implant. People with certain metal sensitivities or toxic metal exposure will not be eligible for the study.

If you choose to participate, you can expect to undergo the normal knee replacement surgery while being monitored for your recovery and the implant's performance over time. The study aims to ensure that this new coating does not affect the implant's effectiveness, and so far, there have been no reported issues with it. Your participation will help researchers gather important data that can improve knee replacement outcomes for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Those older than 18 years old at the surgery time
• • those suitable to undergo to a primary total knee arthroplasty for whom the GMK Sphere TiNb coated device will be implanted (according to the label indication/contraindications)
• • Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to patient's surgery
• Exclusion Criteria:
• • Those patients with metal implants containing Co, Cr and / or Ni
• • Those patients who have had environmental or occupational exposure to toxic metals such as Co, Cr and / or Ni (solvents, industrial paints, welders)
• • Those whose mental conditions may compromise their ability to provide informed consent to study participation, ability to complete questionnaires or complete 10-year follow-ups
• • Those unable to give their consent to participate in the study or who do not want to participate
• • Any condition not mentioned in inclusion criteria.