Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty

Study Overview
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Brief Summary
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Compare sizing determined in pre-operative planning of reverse shoulder arthroplasty to operative implant size selected.

Detailed Description
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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.

Official Title
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A Single-arm, Prospective Study of Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty

Conditions
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Reverse Shoulder Replacement

Intervention / Treatment
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* Device: Reverse shoulder arthroplasty utilizing Blueprint Software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skeletally mature, and age ≥ 18 years. In the opinion of the treating surgeon, must already be a qualified candidate for reverse shoulder arthroplasty without the use of glenoid bone grafts. Be likely to return for regular follow-ups until the end of the study period. Be willing and able to provide Informed Consent for study participation. Exclusion Criteria: Previous bony surgery on the operative shoulder. Shoulder pain due to acute trauma. Clinical, laboratory and/or radiological evidence of shoulder pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.) Any active malignancy, infectious process, or documented chronic autoimmune disease. Any other concurrent medical disease or treatment that might impair normal healing process. Recent history (within past 6 months) of any chemical or alcohol dependence. Currently a prisoner. Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin. Pregnant or planning to become pregnant within study duration.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Implant placement accuracy<br>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. | Device: Reverse shoulder arthroplasty utilizing Blueprint Software<br>* Reverse shoulder arthroplasty utilizing Blueprint Software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |