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This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.
The Comprehensive® Shoulder System with Nano humeral component is a humeral prosthesis system intended for use in total or hemi shoulder arthroplasty surgery. Total shoulder arthroplasty consists of replacement of the humeral head and glenoid. Hemi-arthroplasty consists of replacement of only the humeral head.
This project is a prospective study including one-hundred and fifty (150) anatomic and hemi cases and 44 reverse shoulders collected from up to ten (10) sites. All potential study subjects will be required to participate in the Informed Consent process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anatomic | Patients receiving the Anatomic or Hemi verison of the Comprehensive Nano. |
| |
| Reverse | Patients who have received the Reverse version of the Comprehensive Nano. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Nano | Device | Patients requiring the Comprehensive Nano shoulder system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship | Kaplan Meier method | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| ASES Score (American Shoulder and Elbow Surgeons) | Improvement in this score from preop to 10 year follow-up. This score includes 2 scales: 1 scale for pain, from 0 to 10 where 0 stands for "no pain at all" and 10 for "pain as bad as it can be". The second scale is for the stability of the shoulder, from 0 to 10 (0 stands for "very stable" and 10 for "very unstable"). | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in need of an uncemented shoulder arthroplasty and who meet all of the inclusion and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Paola Vivoda | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Privatklinik Leech | Graz | Styria | 8010 | Austria | ||
| Kingston General Hospital |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| SANE Score (Single Assessment Numeric Evaluation) | Improvement in this score from preop to 10 year follow-up. This is a simple, single-question, patient-based shoulder function assessment tool: "How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?" | 10 years |
| Constant-Murley Score | Improvement in this score from preop to 10 year follow-up. This is a 100-point score. Higher scores indicate a better outcome. | 10 years |
| X-rays evaluated for radiolucencies, osteolysis, migration and subsidence | Standard evaluation performed on both humeral and glenoid components | 10 years |
| Kingston |
| Ontario |
| K7L 3N6 |
| Canada |
| Chonnam National University Hospital | Gwangju | Gwangju | South Korea |
| Samsung Medical Centre | Seoul | Seoul | 06351 | South Korea |
| University of Liverpool | Liverpool | Merseyside | L69 3BX | United Kingdom |
| D001847 |
| Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |