Status:
TERMINATED
Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Osteo Arthritis Shoulders
Traumatic Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
A post market, prospective, non-randomized, multi-center, open-label, clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Titan Modular Shoulder...
Eligibility Criteria
Inclusion
- For total shoulder arthroplasty, subjects must meet a, b, or c below:
- Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. -revision of a failed primary component)
- For shoulder hemiarthroplasty, subjects must meet any of the sub-criteria a - g below:
- Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. -revision of a failed primary component)
- Ununited humeral head fractures
- Avascular necrosis of the humeral head
- Rotator cuff arthropathy
- Deformity and/or limited motion
Exclusion
- Absent, irreparable or nonfunctional rotator cuff or other essential muscles.
- Have an active local or systemic infection.
- Have inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components.
- Have 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.
- Have a muscular, neurologic, or vascular deficiencies that compromise the affected extremity.
- Have a known sensitivity or allergic reaction to one or more of the implanted materials.
- Have a condition that may impair proper wound healing.
Key Trial Info
Start Date :
August 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 10 2023
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03250767
Start Date
August 1 2017
End Date
March 10 2023
Last Update
November 9 2023
Active Locations (7)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0111
2
John Hopkins University
Columbia, Maryland, United States, 21044
3
Mississipi Bone and Joint Clinic
Starkville, Mississippi, United States, 39759
4
The Research Foundation for The State University of New York (SUNY)
Syracuse, New York, United States, 13210