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This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products. The primary objective of the retrieval is to collect data that will contribute to the post market surveillance requirements for this product and will provide feedback to design engineers, support marketing efforts and publications, and answer potential questions form reimbursement agencies.
The Comprehensive Shoulder System has been cleared by the FDA via premarket notifications. No experimental or investigational surgical techniques or devices will be used in this study. All devices and products will be used in accordance with their instructions for use and/or approved labeling. The aim of the Comprehensive Shoulder System is to improve shoulder function and reduce pain.
One site will be used for this database retrieval. The number of patients involved will depend upon the size of the Comprehensive database available at Acromion, LLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biomet Comprehensive Shoulder System | Subjects in need of a total shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Shoulder System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomet Comprehensive Shoulder System | Device | Total shoulder system designed to provide intraoperative flexibility for surgeons with unmatched humeral stem options, and infinite humeral head offset possibilities while meeting the growing demand for ease of glenoid preparation through a streamlined, low-profile, cannulated instrument platform |
| Measure | Description | Time Frame |
|---|---|---|
| Implant survivorship is assessed counting the number of implant revisions | Implant survivorship will be documented by assessing the number of implant revisions occurring throughout the course of the study. | 10 years |
| 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 standard score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function. | 10 years |
| Clinical Safety |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in need of a total shoulder arthroplasty which receive one of the devices in the Comprehensive Shoulder family and who meet all of the inclusion and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Erin D Osborn | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acromion LLC | Towson | Maryland | 21204 | United States |
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| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D001172 | Arthritis, Rheumatoid |
| D000070656 | Rotator Cuff Tear Arthropathy |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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Clinical safety is assessed through documentation of complications occurring during the course of the study. |
| 10 years |
| Clinical Safety - Device Related | Clinical safety is assessed through documentation of device-related events occurring during the course of the study. | 10 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002805 | Chondrocalcinosis |
| D000070657 | Crystal Arthropathies |