Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement

Study Overview
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Brief Summary
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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.

Official Title
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A Post-Market, Prospective, Multi-Center, Open-Label, Single Arm Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement

Conditions
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Osteo Arthritis Shoulders, Traumatic Arthritis, Rheumatoid Arthritis

Intervention / Treatment
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* Device: Integra Titan Modular Shoulder System 2.5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Integra Titan Modular Shoulder System 2.5<br> | Device: Integra Titan Modular Shoulder System 2.5<br>* Primary Shoulder Joint Replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survivorship | Implant survivorship defined as absence of device removal or revision | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survivorship | Implant survivorship defined as absence of device removal or revision | 1,5 and 10 years | 
| Relative change of Range of Motion (ROM) compared to baseline | Relative change of ROM compared to baseline | up to 10 years | 
| Relative change of Constant-Murley Score (CMS) compared to baseline | Relative change of CMS compared to baseline | up to 10 years | 
| Relative change of American Shoulder & Elbow Surgeons Score (ASES) compared to baseline | Relative change of ASES compared to baseline | up to 10 years | 
| Relative change of Single Assessment Numeric Evaluation (SANE) compared to baseline | Relative change of SANE compared to baseline | up to 10 years | 
| Relative change of Simple Shoulder Test (SST) compared to baseline | Relative change of SST compared to baseline | up to 10 years | 
| Relative change of Pain compared to baseline | Relative change of Visual Analogue Scale (VAS) Pain compared to baseline | up to 10 years |