Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement
Stopped early
Conditions studied: Osteo Arthritis Shoulders, Traumatic Arthritis, Rheumatoid Arthritis
In brief
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 System 2.5 when used for primary shoulder arthroplasty.
Key facts
- Study ID
- NCT03250767
- Run by
- Smith & Nephew, Inc.
- People needed
- 58
- Starts
- 2017-08-01
- Expected to finish
- 2023-03-10
- Last updated by the study team
- 2023-11-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- John Hopkins University — Columbia, Maryland, United States
- Mississipi Bone and Joint Clinic — Starkville, Mississippi, United States
- The Research Foundation for The State University of New York (SUNY) — Syracuse, New York, United States
- Westphal Orthopaedics — Lancaster, Pennsylvania, United States
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
- The Rothman Institute — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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