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Study was stopped due to low follow-up compliance at study sites.
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This post-marketing study is designed to collect data relating to the use of the Delta Xtend™ Total Shoulder Replacement System in shoulder with rotator cuff deficiencies. This allows for continued monitoring of the performance and safety of the prosthesis in a broader range of clinical situations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delta Xtend Reverse Total Shoulder | Other | Orthopaedic implant for total shoulder replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delta Xtend Reverse Total Shoulder | Device | Orthopaedic implant for total shoulder replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative functionality at 12weeks, 1, 2, 5 and 10 years through a difference in the Constant score, ASES score, U-Penn score and EQ-5D as compared with pre-treatment scores. | 12weeks, 1, 2, 5 and 10 years | |
| Determine implant survivorship and surgical revision information at 1, 2, 5 and 10 years via Kaplan-Meier survival analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis | Ghent | B-9000 | Belgium | |||
| Clinique Generale D'Annecy |
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| 1, 2, 5 and 10 years |
| Annecy |
| 74000 |
| France |
| CHRU Reims Hôpital Maison Blanche | Reims | 51092 | France |
| Polyclinique de l'Atlantique | Saint-Herblain | 44819 | France |
| Krankenhaus Munchen Bogenhausen | München | 81925 | Germany |
| ID | Term |
|---|---|
| D000070656 | Rotator Cuff Tear Arthropathy |
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D002805 | Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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