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| Name | Class |
|---|---|
| Stryker Trauma and Extremities | INDUSTRY |
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Compare sizing determined in pre-operative planning of reverse shoulder arthroplasty to operative implant size selected.
The Blueprint planning software automatically creates a virtual implantation environment for the surgeon to use. The use of 3D measurements is independent of patient positioning, which results in more accurate measurements of the glenoid version and inclination measurements in shoulder replacement surgery.
Pre-operative planning with Blueprint can accurately predict intraoperative implant selection within one size. Also, pre-operative planning leads to case efficiency and improved functional outcomes at 6 months post-operative compared to Baseline.
The objective of this study is to characterize implant size accuracy, planning time, functional outcomes, and procedural time (i.e., surgical time) using Blueprint planning software in subjects who are candidates for reverse shoulder arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant placement accuracy | Other | Blueprint planning software will be used to plan reverse shoulder replacement surgery. Accuracy of the placement compared to the plan will be assessed post-surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reverse shoulder arthroplasty utilizing Blueprint Software | Device | Reverse shoulder arthroplasty utilizing Blueprint Software |
|
| Measure | Description | Time Frame |
|---|---|---|
| Range of motion | Range of motion of the operative shoulder | 6 months |
| Accuracy of sizing | Blueprint planned implant size compared to actual implant size | Perioperative |
| Time to plan/perform case | Time required for surgeon to plan and perform the case using the Bluerpint software | Pre-operative |
| Time to plan/perform case | Time required for surgeon to plan and perform the case using the Bluerpint software | Perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) | Questionnaire to score and understand how well you function in everyday life, concerning your shoulder pain/limitations. 0-100 score, with higher score indicating higher functionality. | 12 weeks |
| American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Googe, MD | Orthopedics Specialists of Louisiana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine Institute of Louisiana | Shreveport | Louisiana | 71101 | United States |
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Questionnaire to score and understand how well you function in everyday life, concerning your shoulder pain/limitations. 0-100 score, with higher score indicating higher functionality. |
| 6 months |
| Simple Shoulder Test (SST) Questionnaire | 12 yes/no questions to understand your daily functionality concerning your shoulder. | Pre-operative |
| Simple Shoulder Test (SST) Questionnaire | 12 yes/no questions to understand your daily functionality concerning your shoulder. | 2 weeks |
| Simple Shoulder Test (SST) Questionnaire | 12 yes/no questions to understand your daily functionality concerning your shoulder. | 6 weeks |
| Simple Shoulder Test (SST) Questionnaire | 12 yes/no questions to understand your daily functionality concerning your shoulder. | 12 weeks |
| Simple Shoulder Test (SST) Questionnaire | 12 yes/no questions to understand your daily functionality concerning your shoulder. | 6 months |
| Patient Satisfaction | Patient rated satisfaction with surgical treatment rated; very satisfied, somewhat satisfied, somewhat dissatisfied, or very dissatisfied | 12 weeks |
| Patient Satisfaction | Patient rated satisfaction with surgical treatment rated; very satisfied, somewhat satisfied, somewhat dissatisfied, or very dissatisfied | 6 months |