Clinical Evaluation of the TITAN™ Total Shoulder System

Smith & Nephew, Inc.50 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Arthritis Arthritis, Degenerative Rheumatoid Arthritis Post-traumatic Arthrosis of Other Joints, Shoulder Region Rotator Cuff Syndrome of Shoulder and Allied Disorders

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System. 2. 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. 3. Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures. Exclusion Criteria: 1. 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. 2. Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.

Locations (2)

OrthoIndy

Indianapolis, Indiana, United States

The Rothman Institute

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Implant survival at 2 years

Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).

Time frame: 2 years

Secondary Outcomes

Implant survival .

Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).

Time frame: 5 and 10 years

Relative change of Range of Motion (ROM) compared to baseline