Arthritis, Arthritis, Degenerative, Avascular Necrosis, Dislocation, Shoulder, Fracture, Joint Instability, Joint Trauma, Pain, Shoulder, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Rheumatoid Arthritis, Rotator Cuff Syndrome of Shoulder and Allied Disorders
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEIntegra TITAN™ Total Shoulder Generation 1.0
Total Shoulder Arthroplasty or Hemiarthroplasty
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant survival at 2 years | 2 years | Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant survival . | 5 and 10 years | Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s). |
| Relative change of Range of Motion (ROM) compared to baseline | 2, 5, and 10 years | Relative change of Range of Motion (ROM) compared to baseline |
| Radiographic assessment | 2, 5, and 10 years | Radiographic assessment for loosening, malpositioned implant, subsidence, subluxation, and radiolucency |
| Relative change in Quality Of Life (EQ-5D) compared to baseline | 2, 5, and 10 years | Relative change in Quality Of Life (EQ-5D) compared to baseline |
| Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline | 2, 5, and 10 years | Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline |
| Relative change of PENN Pain and Function Score (PENN) compared to baseline | 2, 5, and 10 years | Relative change of PENN Pain and Function Score (PENN) compared to baseline |
| Relative change in Quality Of Life (SF-12V1) compared to baseline | 2, 5, and 10 years | Relative change in Quality Of Life (SF-12V1) compared to baseline |
Countries
United States
Outcome results
None listed