Clinical Evaluation of the TITAN™ Total Shoulder System

Stopped early

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

In brief

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.

Key facts

Study ID

NCT03245320

Run by

Smith & Nephew, Inc.

People needed

50

Starts

2017-03-20

Expected to finish

2022-06-23

Last updated by the study team

2023-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
• The first generation TITAN Total Shoulder System is still intact and the subject has not received any revision surgeries involving the TITAN Total Shoulder System.
• Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.

You may not qualify if…

• Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study such as mental illness, or drug or alcohol abuse.
• Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.

Where it is running

• OrthoIndy — Indianapolis, Indiana, United States
• The Rothman Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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