Clinical Evaluation of the TITAN™ Total Shoulder System
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis, Orthopedic, Orthopedic, Orthopedic |
Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/27/2019 |
Start Date: | March 20, 2017 |
End Date: | June 2028 |
A Post-Market Observational Study to Evaluate Performance and Safety of the TITAN™ Total Shoulder System
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.
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.
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.
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.
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