Arcos Clinical Outcomes Study, revision 1
Research type
Research Study
Full title
Arcos Modular Femoral Revision System Clinical Outcomes Study
IRAS ID
232813
Contact name
Vijay Vardhan Killampalli
Contact email
Sponsor organisation
Zimmer GmbH
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The primary aim of this retrospective and prospective Clinical Outcomes Study, is to report the clinical and radiographic results from revision hip arthroplasty, using the commercially available cementless Arcos Modular Femoral Revision System.
This data collection will occur at a single UK centre, and will review a consecutive series of patients who have previously received the implant by the Principle Investigator, Mr. Killampalli and have a minimum of 12 months FUP. The aim is to collect high quality data, which will allow for publication in a peer-reviewed journal.
Subjects who agree to participate in the Clinical Outcomes Study and provide written consent, will be required to attend a single prospective post-operative clinical evaluation at a minimum of 12 months after receiving their Arcos revision stem. This will involve completing a series of questionnaires and having an X-ray taken.
Details of their operative procedure, demographic information and pre-operative conditions will be collected retrospectively. Any previous follow-up visits will also be collected retrospectively.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0238
Date of REC Opinion
19 Sep 2018
REC opinion
Further Information Unfavourable Opinion