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This study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse Shoulder System when used with the Comprehensive Porous Augmented Glenoid Baseplate and/or Comprehensive Mini Humeral Tray in primary and revision reverse shoulder arthroplasty.
The Comprehensive Reverse Porous Augmented Glenoid Baseplate and Comprehensive Mini Humeral Tray belong to the Comprehensive Reverse Shoulder Arthroplasty System. They were developed to provide patients with grossly deficient rotator cuffs with another surgical option. The aim of the Comprehensive Reverse Shoulder System is to increase shoulder function while reducing pain.
A maximum of 7 sites will contribute to this study. Enrollment of 7 sites on a global scale will allow for assessment of device consistency across different regions. Enrollment per site will not exceed 45 shoulders. 146 implants will be included in this study with competitive enrollment. All potential study subjects will be required to participate in the Informed Consent process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comp. Rev. Porous Augmented Glenoid | Experimental | Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Porous Augmented Glenoid. |
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| Comp. Rev. Mini Humeral Tray | Experimental | Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Mini Humeral Tray |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Reverse Porous Augmented Glenoid | Device | Three glenoid baseplate options designed for various severities of glenoid erosion and deformity, the device promotes bony ingrowth while restoring natural human anatomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survivorship | Based on removal or intended removal of the device and determined using the Kaplan-Meier method | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Incidence of Adverse Events | Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies. | 10 years |
| Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Score Patient Questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Overholser | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andrews Research and Education Foundation | Gulf Breeze | Florida | 32561 | United States | ||
| Norton Orthopedic Specialists |
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| Comprehensive Mini Humeral Tray | Device | The mini humeral tray offers additional sizing options to the Comprehensive Shoulder line. The mini tray is designed to fit smaller anatomies. |
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Pain, function, and activities of daily living are measured. The American Shoulder and Elbow Surgeon (ASES) scale is 0-100. 100 is the highest score and indicates the greatest function while 0 is the lowest score. |
| 10 years |
| Radiographic Performance | X-rays will be evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes, component migration, scapular notching and heterotopic ossification | 10 years |
| Louisville |
| Kentucky |
| 40241 |
| United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| The Research Foundation for the State University of New York | Buffalo | New York | 14215 | United States |
| Campbell Foundation | Germantown | Tennessee | 38138 | United States |
| The Rector and Visitors of the University of Virginia | Charlottesville | Virginia | 22903 | United States |