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The objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary Revision Stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.
The safety of this device will be assessed by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The performance will be evaluated by assessment of reported clinical outcome measures (PROMs) as well as radiographic outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | The study population will comprise a consecutive cohort of 59 cases (males and females), implanted with the Comprehensive Primary Revision Stem. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Primary Revision Stems | Device | Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survivorship at 10 years follow-up (Kaplan Meier) | Based on removal or intended removal of the device and determined using the Kaplan-Meier method. | 10 years |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Device Performance and Benefits evaluated through the Western Ontario Arthritis of the Shoulder (WOOS) outcome measure. | The secondary objective is the assessment of performance and clinical benefits by recording patient reported clinical outcome measures (PROMs), through the use of the Western Ontario Osteoarthritis of the Should Score (WOOS). The WOOS is a 19 item questionnaire. Patients rate their symptoms from no pain extreme pain. The total score is calculated where 0 is a normal healthy shoulder and 1900 is the worst possible result. WOOS% (% of raw score) can be calculated using the formula (1900 - the score)/19 and then 0% is the worst possible result and 100% is the best possible result. |
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Inclusion Criteria
Exclusion Criteria
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Consecutive series of subjects implanted with the Comprehensive Primary Revision Stems according to the approved indications will be identified and invited to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Boylan, MBA | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 900033 | United States | ||
| Aalborg University Hospital |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D000070599 | Shoulder Injuries |
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| 10 years |
| Aalborg |
| DK-9000 |
| Denmark |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |