14022 - Clinical Evaluation of the Cementless ATTUNE TKA System
Research type
Research Study
Full title
Multi-Center Clinical Evaluation of the ATTUNE® Cementless Rotating Platform Total Knee Arthroplasty.
IRAS ID
194537
Contact name
Sue Kemp
Contact email
Sponsor organisation
DePuy Synthes Joint Reconstruction
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 1 months, 10 days
Research summary
This study has been designed to assess changes from the pre-operative to two years post-operative timepoint in the functional performance of the ATTUNE Cementless Rotating Platform (RP) knee system in primary total knee replacement (TKA) surgery. The ATTUNE Rotating Platform (RP) system will be available in two configurations: cruciate retaining (CR RP) and posterior stabilized (PS RP); both will be assessed in the study.\n\nThe CR RP configuration of the ATTUNE cementless knee system, is expected to receive CE marking and approval for use in the UK in April 2016; enrolment won’t begin until CE marked products are available.\n\nThe study will assess outcome scores (patient reported outcomes, PROs), radiographic outcomes and safety performance in both configurations. \n500 participants (250 implanted with each configuration) with non-inflammatory degenerative joint disease (NIDJD) resulting from osteoarthritis (OA) or post-traumatic arthritis, aged 22-80 years will be included in total worldwide.\n\nThe anticipated recruitment period for each configuration is 12 months, with 5 years post-operative follow-up. The configurations won’t be available concurrently so the overall total anticipated duration will be 7 years. Participants will attend clinic visits at pre-op, surgery, 6 weeks, 6 months, 1, 2 and 5 years with telephone follow-up at 3 and 4 years. \n\nPre-operatively; basic demographic data will be collected including medical history, with 6 PROs and one surgeon evaluation questionnaire.\n\nSurgical data will be collected intra-operatively. \n\nDuring the 6 week, 6 month, 1, 2 and 5 year follow-up visits, participants will have x-rays taken (AP view, lateral view) and undergo 5 PROs and one surgeon evaluation questionnaire. \n\nThe purpose of the 3 and 4 year telephonic assessment is to optimise the accuracy of survivorship data; enabling timely capture of AEs and maximize chances of long term follow-up.\n\nFollowing 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
16/YH/0134
Date of REC Opinion
14 Jun 2016
REC opinion
Further Information Favourable Opinion