ALknee Follow-up Study of the Cementless ATTUNE Rotating Platform and the Cementless LCS Rotating Platform Knee System

Launched by SPAARNE GASTHUIS · Nov 14, 2022

Keywords

ClinConnect Summary

The ALknee Follow-up Study is looking at two types of cementless knee replacement systems: the ATTUNE and the LCS. Researchers want to see how these knee systems behave over time in terms of their position and movement within the body after surgery. They are particularly interested in understanding if the ATTUNE system stays securely in place as well as, or better than, the LCS system over a longer period. Additionally, they are exploring a new measurement method called Induced Displacement, which helps determine if the knee implant is properly bonded to the bone, which is crucial for long-term success.

To participate in this study, individuals must have been part of an earlier related study and must be able to give informed consent. They cannot have had any major knee surgeries in the past that involved replacing parts of the knee implant. Participants can expect to undergo follow-up assessments over the next 5 to 10 years to monitor how well their knee replacement is functioning and to gather information about their recovery and quality of life. This study is currently not recruiting new participants, but it aims to provide valuable insights into the long-term performance of these knee replacement options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• • The Patient participated in the initial study (NL58911.058.16) \[1\].
• • The patient is capable of giving informed consent and expressing a willingness to comply with the study.
• Exclusion Criteria:
• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• • The patient underwent a major revision TKR (exchange of the tibial or femoral component).
• • The patient is unable or unwilling to sign the informed consent specific to this study.

Trial Officials