Clinical Evaluation of the TITAN™ Total Shoulder System

Rheumatoid Arthritis Clinical Trial

Official title: A Post-Market Observational Study to Evaluate Performance and Safety of the TITAN™ Total Shoulder System

Status Terminated

Clinical Trial Summary

A post market, non-randomized, multi-center, open-label,clinical study using survivorship to study the safety and efficacy of the Integra® TITAN™ Total Shoulder System 1.0 (TAS) when used for total shoulder arthroplasty.

Clinical Trial Description

Observational, multi-center, post-market study to provide data on the performance and safety of the TITAN™ Total Shoulder System. The study will enroll patients that underwent total shoulder arthroplasty with the TITAN™ Total Shoulder System per standard of care less than 5 years ago. Available retrospective data up to the 2-year time point will be collected, per the study protocol, from medical record reviews. Prospective observational data will be collected from the time of patient enrollment during the following postoperative clinical visits: 1 year, 2 years, 5 years and 10 years post-surgery. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Degenerative
• Avascular Necrosis
• Dislocation, Shoulder
• Fracture
• Joint Instability
• Joint Trauma
• Necrosis
• Osteoarthritis
• Pain, Shoulder
• Post-traumatic Arthrosis of Other Joints, Shoulder Region
• Rheumatoid Arthritis
• Rotator Cuff Syndrome of Shoulder and Allied Disorders
• Shoulder Dislocation
• Shoulder Pain

• NCT number: NCT03245320
• Study type: Observational
• Source: Smith & Nephew, Inc.
• Status: Terminated
• Start date: March 20, 2017
• Completion date: June 23, 2022