Status:
TERMINATED
TITAN™ Reverse Shoulder System
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Osteoarthritis of the Shoulder
Eligibility:
All Genders
21+ years
Brief Summary
The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. When used under the conditions and purposes intended the TRS will relieve pain and restore some functi...
Eligibility Criteria
Inclusion
- Subjects with grossly deficient rotator cuff with severe arthropathy or Subjects with failed joint replacement with grossly deficient rotator cuff
- Subjects with a shoulder joint anatomically and structurally suited to receive the device
- Subjects at least 21 years of age and skeletally mature at the time of surgery
- Subject provided consent to participate in the clinical study (having signed the Informed Consent Form)
Exclusion
- Subjects without a functional deltoid muscle
- Subjects with active local or systemic infection
- Subjects with inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
- Subjects with poor bone quality such as osteoporosis where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid
- Subjects with muscular, neurologic, or vascular deficiencies that compromise the affected extremity
- Subjects with known metal allergies
- Subjects are known to be at risk for lost to follow-up, or failure to return for scheduled visits
- Subjects who are prisoners
- Female subject who are pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 14 2023
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT02204228
Start Date
September 1 2014
End Date
December 14 2023
Last Update
September 10 2025
Active Locations (10)
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1
University of Florida
Gainesville, Florida, United States, 32607
2
Johns Hopkins University
Columbia, Maryland, United States, 21044
3
Mississipi Bone and Joint Clinic
Starkville, Mississippi, United States, 39759
4
Active Orthopedics
Glen Ridge, New Jersey, United States, 07028