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The goal of this multi-center observational study is to collect long-term clinical outcome information for anatomic and reverse total shoulder arthroplasty (shoulder replacement).
The study is a non-randomized, multi-center prospective registry that will collect standard-of-care data for patients who plan to receive or have received shoulder arthroplasty (anatomic or reverse) with a Shoulder Innovations (SI) Total Shoulder System device and consent to participate in the study. The study will evaluate short and long term clinical and radiographic outcomes associated with real-world use of the arthroplasty system from the implant procedure through 10 years post-operatively.
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| Measure | Description | Time Frame |
|---|---|---|
| Durability of the device component implant | Assessment of the SI device component will be made at specified intervals using x-rays to check how long the device component can stay implanted with or without a revision surgery. | From the implant procedure until 10 years post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Change in range of motion (ROM) post-operatively at specified timepoints as compared to baseline | From baseline (pre-operatively) until 10 years post-operatively | |
| Change in ASES score post-operatively at specified timepoints as compared to baseline | Patients will complete the ASES questionnaire (American Shoulder and Elbow Surgeons Shoulder Score) to evaluate pain and activities of daily living. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (at least 18 years of age) of any gender undergoing a shoulder arthroplasty for any diagnosis/condition with at least one SI Total Shoulder System component enrolled at participating sites
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alyson Harris | Contact | 408-667-0535 | alyson.harris@shoulderinnovations.com | |
| Michele La Badie | Contact | 615-603-8110 | michele.labadie@shoulderinnovations.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Orthopedics | Recruiting | Birmingham | Alabama | 35205 | United States |
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| From baseline (pre-operatively) until 10 years post-operatively |
| Change in SANE score post-operatively at specified timepoints as compared to baseline | Patients will complete the SANE questionnaire (Single Assessment Numeric Evaluation) to rate their affected shoulder as a percentage of normal. | From baseline (pre-operatively) until 10 years post-operatively |
| Change in PROMIS Global-10 score post-operatively at specified timepoints as compared to baseline | Patients will complete the PROMIS Global-10 questionnaire (Patient-Reported Outcome Measurement Information System Global-10) to evaluate pain and activities of daily living. | From baseline (per-operatively) until 10 years post-operatively |
| Evaluation of radiographic images for radiolucent lines, implant stability and loosening | From baseline (pre-operatively) until 10 years post-operatively |
| Rate of intra-operative and post-operative adverse device effects (ADEs)/complications | From the implant procedure until 10 years post-operatively |
| St. Vincent's Orthopedics | Enrolling by invitation | Birmingham | Alabama | 35205 | United States |
| California Pacific Orthopaedics | Recruiting | San Francisco | California | 94118 | United States |
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| Western Orthopaedics | Recruiting | Denver | Colorado | 80222 | United States |
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| Connolly Orthopedics | Recruiting | Bradenton | Florida | 34208 | United States |
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| Georgia Bone and Joint | Recruiting | Newnan | Georgia | 30265 | United States |
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| North Shore Physicians Group | Recruiting | Peabody | Massachusetts | 01960 | United States |
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| University Medical Center of Southern Nevada | Enrolling by invitation | Las Vegas | Nevada | 89102 | United States |