T-TSS-003
Research type
Research Study
Full title
A Post-Market, Prospective, Multi-Center, Open-Label, Single Arm Clinical Evaluation of the Integra® Titan™ Modular Shoulder System 2.5 for Primary Shoulder Joint Replacement
IRAS ID
281029
Contact name
Andrew Tummon
Contact email
Sponsor organisation
Integra LifeSciences
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 0 months, 1 days
Research summary
Conditions that lead to shoulder replacement include osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis, and severe fractures. Symptoms that are experienced prior to shoulder replacement are severe shoulder pain, loss of motion and weakness in the shoulder and failure of other treatment methods (anti-inflammatory medication, corticosteroid injections, and physical therapy). Shoulder replacement is a safe and effective procedure done to provide pain relief and help patient resume shoulder function. In this study, we will evaluate the clinical outcomes of the Integra® Titan™ Modular Shoulder System 2.5 (TSS-2.5). This is a prospective, multi-center clinical study on a CE-marked device (used in its indication) using survivorship as the reference performance goal. Up to 15 centers may enroll and implant a maximum of 25 patients each. Total target enrollment is 140 enrolled and implanted patients.
REC name
London - Surrey Research Ethics Committee
REC reference
20/PR/0308
Date of REC Opinion
9 Oct 2020
REC opinion
Further Information Favourable Opinion