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This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse Shoulder. The secondary objective is collection of long term clinical outcomes.
The Biomet Comprehensive Reverse Shoulder was developed to provide an additional surgical option for patients anatomically and structurally suited to receive a reverse shoulder arthroplasty. The aim of the Biomet Comprehensive Reverse Shoulder is to increase shoulder function while reducing pain.
This is a multi-center study. Having several clinical sites will allow for multiple investigators to contribute to the results of the study. 175 implants will be included into the study. All potential study subjects will be required to participate in the Informed Consent Process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biomet Comprehensive Reverse Shoulder | Subjects in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Shoulder System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomet Comprehensive Reverse Shoulder | Device | Designed to eliminate the potential for scapular notching, this reverse shoulder system combines a a true locking mechanism that minimized wear and oxidative breakdown with a modular central screw for secure fixation. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Pain Score is assessed for each subject by asking them to indicate their current level of pain based on a 5 level scale, with "None" as the best outcome and "Severe" as the worst. Improvement of pain score at one year from pre-operative levels will be assessed. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Constant Shoulder Score | The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function. | Pre-operative, 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in need of a reverse shoulder arthroplasty which receive the Biomet Comprehensive Reverse Shoulder and who meet all of the inclusion and none of the exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acromion LLC | Towson | Maryland | 21204 | United States | ||
| William Beaumont Hospital |
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| Presence of Scapular Notching |
All radiographic images collected during the study are assessed by the Principal Investigator for the presence of scapular notching. The severity of notching will be assessed using the Nerot system, where Grade 0 indicates no notch and Grade 4 indicates the largest-sized defect in the scapula. |
| 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years |
| Royal Oak |
| Michigan |
| 48073 |
| United States |
| Allina Health System DBA Sports and Orthopaedic Specialists | Edina | Minnesota | 55439 | United States |
| Joint Implant Surgeons | New Albany | Ohio | 43054 | United States |