Clinical Evaluation of ATTUNE® Revision - Complex Primary TKA
Research type
Research Study
Full title
Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Complex Primary Total Knee Arthroplasty
IRAS ID
224671
Contact name
John Paul Whittaker
Contact email
Sponsor organisation
Medical Device Business Services, Inc.
Duration of Study in the UK
8 years, 3 months, 29 days
Research summary
This study has been designed to evaluate the changes from pre-operative baseline to the 2 year time point in patient reported functional outcome and knee injury osteoarthritis outcome for the ATTUNE® Revision TKA system in Complex Primary total knee arthroplasty (TKA) surgery. The ATTUNE® Revision TKA system will be available in two configurations: the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component; both will be assessed in the study.
The FB tibial base and the 14x50 mm cemented stem configuration of the ATTUNE® Revision knee system, has received CE marking and approval for use in the UK in March 2017.
The FB PS configuration of the ATTUNE® Revision knee system is expected to receive CE marking and approval for use in the UK in July 2017; the RP PS configuration is expected to receive CE marking and approval for use in the UK in October 2017. Enrolment for participants will not begin until CE marked products are available.
The study will assess outcome scores (patient reported outcomes, PROs), radiographic outcomes and safety performance in both configurations.
The anticipated recruitment period is 2 years, with 5 years post-operative follow-up. Participants will attend clinic visits at pre-op, surgery, 6 weeks, 1, 2 and 5 years with telephone follow-up at 3 and 4 years. The purpose of the 3 and 4 year telephonic assessment is to optimise the accuracy of survivorship data; enabling timely capture of Adverse Events and maximize chances of long term follow-up.
Following study completion, participants’ on-going follow-up will be per the hospitals standard care.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
17/YH/0131
Date of REC Opinion
16 May 2017
REC opinion
Further Information Favourable Opinion