Attune™ Primary TKA Survivorship
Research type
Research Study
Full title
Short, Medium and Long Term Survivorship of Attune™ Primary Total Knee Prostheses
IRAS ID
137747
Contact name
Dianne Back
Contact email
Research summary
Total joint arthroplasty, especially hip and knee replacement, has evolved into a highly successful surgical procedure, providing excellent survivorship, pain relief and improvement of the quality of life for the majority of patients who elect to have the surgery. Although implant durability is considered a basic requirement of any implant system, increasing demands for TKA performance are predicted based on changing patient populations. Since 1997, the distribution of patient age has shifted to younger patients. Patients are also more obese and have a higher number of preoperative co-morbidities. Based on these changes in demographics, patients will increasingly demand more from their TKAs, including implant durability. Therefore, the follow-up period of 15 years was selected for this study.
This study has been designed to prospectively collect suvivorship and patient reported outcome data on a primary total knee replacement device which is currently CE Marked and approved for use in the UK. The aims of this study are to assess the short, medium and long-term survivorship of all four configurations of the Attune™ implant system.
This study will also aim to evaluate the clinical, functional, radiographic and safety performance of a new knee system using patient outcomes scores.
1200 subjects with non-inflammatory degenerative joint disease and aged 22-75 years will be included at UK/international hospitals. The anticipated recruitment period is 1.5 years and the subject follow up period is 15 years. Therefore the total study duration is 16.5 years. Subjects included in the study will have study clinic visits at pre-operatively, surgery, and post-operatively at < 1 year, minimum 1 year, minimum 2 years, minimum 5 years, minimum 10 years, and minimum 15 years. During these visits the subjects will be asked to complete knee outcome scores, and a set of x-rays will be taken (AP view, Lateral view, and Skyline view). Subjects who choose to participate in the study may be required to attend up to four additional visits (dependent on standard practice at their hospital).
The study subjects will also have telephone contact visits at years 3, 4, 6, 7, 8, 9, 11, 12, 13, and 14.
Following completion of the study, follow up care for the study subjects will be as per the standard care of their hospital.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
14/YH/0040
Date of REC Opinion
26 Feb 2014
REC opinion
Favourable Opinion