Clinical Evaluation of the TITAN™ Total Shoulder System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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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

Intervention / Treatment
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* Device: Integra TITAN™ Total Shoulder Generation 1.0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TITAN™ Total Shoulder System Generation 1.0<br>Integra TITAN™ Total Shoulder System Generation 1.0 | Device: Integra TITAN™ Total Shoulder Generation 1.0<br>* Total Shoulder Arthroplasty or Hemiarthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival . | Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s). | 5 and 10 years | 
| Relative change of Range of Motion (ROM) compared to baseline | Relative change of Range of Motion (ROM) compared to baseline | 2, 5, and 10 years | 
| Radiographic assessment | Radiographic assessment for loosening, malpositioned implant, subsidence, subluxation, and radiolucency | 2, 5, and 10 years | 
| Relative change in Quality Of Life (EQ-5D) compared to baseline | Relative change in Quality Of Life (EQ-5D) compared to baseline | 2, 5, and 10 years | 
| Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline | Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline | 2, 5, and 10 years | 
| Relative change of PENN Pain and Function Score (PENN) compared to baseline | Relative change of PENN Pain and Function Score (PENN) compared to baseline | 2, 5, and 10 years | 
| Relative change in Quality Of Life (SF-12V1) compared to baseline | Relative change in Quality Of Life (SF-12V1) compared to baseline | 2, 5, and 10 years |