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Sponsor decision not due to adverse events, complications, or device issues.
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A post market, prospective, non-randomized, multi-center, open-label, clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Titan Modular Shoulder System 2.5 when used for primary shoulder arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integra Titan Modular Shoulder System 2.5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integra Titan Modular Shoulder System 2.5 | Device | Primary Shoulder Joint Replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survivorship | Implant survivorship defined as absence of device removal or revision | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survivorship | Implant survivorship defined as absence of device removal or revision | 1,5 and 10 years |
| Relative change of Range of Motion (ROM) compared to baseline | Relative change of ROM compared to baseline |
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Inclusion Criteria:
For total shoulder arthroplasty, subjects must meet a, b, or c below:
For shoulder hemiarthroplasty, subjects must meet any of the sub-criteria a - g below:
Exclusion Criteria:
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Patients with shoulder arthritis requiring primary shoulder joint replacement
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-0111 | United States | ||
| John Hopkins University |
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| up to 10 years |
| Relative change of Constant-Murley Score (CMS) compared to baseline | Relative change of CMS compared to baseline | up to 10 years |
| Relative change of American Shoulder & Elbow Surgeons Score (ASES) compared to baseline | Relative change of ASES compared to baseline | up to 10 years |
| Relative change of Single Assessment Numeric Evaluation (SANE) compared to baseline | Relative change of SANE compared to baseline | up to 10 years |
| Relative change of Simple Shoulder Test (SST) compared to baseline | Relative change of SST compared to baseline | up to 10 years |
| Relative change of Pain compared to baseline | Relative change of Visual Analogue Scale (VAS) Pain compared to baseline | up to 10 years |
| Columbia |
| Maryland |
| 21044 |
| United States |
| Mississipi Bone and Joint Clinic | Starkville | Mississippi | 39759 | United States |
| The Research Foundation for The State University of New York (SUNY) | Syracuse | New York | 13210 | United States |
| Westphal Orthopaedics | Lancaster | Pennsylvania | 17601 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| The Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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