Titan Reverse Shoulder CP-0960-001
Research type
Research Study
Full title
A post-market clinical follow-up study of the TITAN Reverse Shoulder System used in primary or revision total shoulder arthroplasty
IRAS ID
244782
Contact name
Marilyne Blanc
Contact email
Sponsor organisation
Smith & Nephew
Clinicaltrials.gov Identifier
Duration of Study in the UK
11 years, 6 months, 2 days
Research summary
Conditions that lead to shoulder replacement include osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, rotator cuff tear arthropathy, avascular necrosis, and severe fractures. Reverse shoulder arthroplasty was first introduced in the 1970’s in response to the difficulty in treating patients with rotator cuff tear arthropathy. The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. When used under the conditions and purposes intended, the TRS may relieve pain and restore functional joint motion to the affected shoulder. The purpose of this study is to assess the short (2-year), mid (5-year) and long term (10-year) outcomes of the TRS. This is a multi-center, prospective, post-market clinical follow up study. The study follow-up is for 10 years and 150 shoulders will be enrolled. Up to 15 investigational sites will participate in this study. Each site will enroll up to 45 subjects.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/1188
Date of REC Opinion
23 Aug 2018
REC opinion
Further Information Favourable Opinion