Status:
TERMINATED
Clinical Evaluation of the TITAN™ Total Shoulder System
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Arthritis
Arthritis, Degenerative
Eligibility:
All Genders
18+ years
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 sh...
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 arthropla...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 20 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 23 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03245320
Start Date
March 20 2017
End Date
June 23 2022
Last Update
December 21 2023
Active Locations (2)
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1
OrthoIndy
Indianapolis, Indiana, United States, 46278
2
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107