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Terminated by the Sponsor. Decision not due to adverse events, complications, or device issues.
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A post market, non-randomized, multi-center, open-label,clinical study using survivorship to study the safety and efficacy of the Integra® TITAN™ Total Shoulder System 1.0 (TAS) when used for total shoulder arthroplasty.
Observational, multi-center, post-market study to provide data on the performance and safety of the TITANâ„¢ Total Shoulder System. The study will enroll patients that underwent total shoulder arthroplasty with the TITANâ„¢ Total Shoulder System per standard of care less than 5 years ago. Available retrospective data up to the 2-year time point will be collected, per the study protocol, from medical record reviews. Prospective observational data will be collected from the time of patient enrollment during the following postoperative clinical visits: 1 year, 2 years, 5 years and 10 years post-surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TITANâ„¢ Total Shoulder System Generation 1.0 | Integra TITANâ„¢ Total Shoulder System Generation 1.0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integra TITANâ„¢ Total Shoulder Generation 1.0 | Device | Total Shoulder Arthroplasty or Hemiarthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival at 2 years | Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival . | Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s). | 5 and 10 years |
| Relative change of Range of Motion (ROM) compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Tummon | Integra LifeSciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoIndy | Indianapolis | Indiana | 46278 | United States | ||
| The Rothman Institute |
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Relative change of Range of Motion (ROM) compared to baseline
| 2, 5, and 10 years |
| Radiographic assessment | Radiographic assessment for loosening, malpositioned implant, subsidence, subluxation, and radiolucency | 2, 5, and 10 years |
| Relative change in Quality Of Life (EQ-5D) compared to baseline | Relative change in Quality Of Life (EQ-5D) compared to baseline | 2, 5, and 10 years |
| Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline | Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline | 2, 5, and 10 years |
| Relative change of PENN Pain and Function Score (PENN) compared to baseline | Relative change of PENN Pain and Function Score (PENN) compared to baseline | 2, 5, and 10 years |
| Relative change in Quality Of Life (SF-12V1) compared to baseline | Relative change in Quality Of Life (SF-12V1) compared to baseline | 2, 5, and 10 years |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D050723 | Fractures, Bone |
| D010020 | Osteonecrosis |
| D007593 | Joint Instability |
| D012783 | Shoulder Dislocation |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| 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 |
| D014947 | Wounds and Injuries |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004204 | Joint Dislocations |
| D000070599 | Shoulder Injuries |
| D018771 | Arthralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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