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This is a multicenter, prospective, non-controlled post market surveillance study. The objectives of this study are to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems in primary anatomic shoulder arthroplasty and its instrumentation. Safety of the systems will be assessed by monitoring the frequency and incidence of adverse events. The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, qualify of life, and radiographic parameters of all enrolled study subjects.
The primary endpoint for this study will be performance assessed by improvement in the American Shoulder and Elbow Surgeons (ASES) shoulder score from baseline to 2 years (as evaluated using the overall cohort mean showing at least the minimal clinically important difference (MCID) of 6.4 points).
The secondary endpoint is represented by the safety of the system, which will be assessed by monitoring the frequency and incidence of adverse events. The secondary endpoint evaluation will also assess the overall pain, functional performance, quality of life and radiographic parameters of all enrolled study subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zimmer Biomet Total Shoulder Arthroplasty System | Patients who are having primary total shoulder arthroplasty who will receive a Zimmer Biomet Total Shoulder Arthroplasty System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allianceâ„¢ Glenoid | Device | Total Shoulder Arthroplasty using the Allianceâ„¢ Glenoid implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) | The primary endpoint for this study will be performance assessed by improvement in the American Shoulder and Elbow Surgeons (ASES) shoulder score from baseline to 2 years (as evaluated using the overall cohort mean showing at least the minimal clinically important difference (MCID) of 6.4 points). Pain, function, and activities of daily living are measured. The ASES scale is 0-100. 100 is the highest score and indicates the greatest function while 0 is the lowest score. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Incidence of Adverse Events (Safety) | Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies. | 10 years |
| Euroqol Patient Quality of life (EQ-5D-5L) |
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Inclusion Criteria:
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
Difficult clinical management problems, where other method of treatment may not be suitable or may be inadequate.
Exclusion Criteria:
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The Alliance Glenoid is intended to be used as part of an anatomic total shoulder arthroplasty to reduce shoulder pain an improve shoulder function. The Alliance Glenoid is intended to be used as a component of a total shoulder replacement system for primary arthroplasty. It provides the surface on the glenoid side that articulates with the modular head component and stem component on the humeral side. Patients must meet all inclusion and none on the exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carina Hafner | Contact | +41 79 707 30 93 | carina.hafner@zimmerbiomet.com | |
| Lisa To | Contact | Lisa.To@zimmerbiomet.com |
| Name | Affiliation | Role |
|---|---|---|
| Emilie Rohmer | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ARCUS Kliniken Pforzheim | Recruiting | Pforzheim | 75179 | Germany |
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| D000070599 | Shoulder Injuries |
| D020069 | Shoulder Pain |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D018771 | Arthralgia |
| D009140 | Musculoskeletal Diseases |
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The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death. |
| 10 years |
| Radiographic Performance | X-Rays will be evaluated for radiolucency, osteolysis, osteophytes, component migration, subsidence and heterotopic ossification. | 10 years |
| Meander Medisch Centrum | Recruiting | Amersfoort | TZ | 3813 | Netherlands |
|
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |