Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty

Study Overview
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Brief Summary
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The hypothesis is that computer simulated bony impingement of the bone surrounding the spherical glenoid implant (the glenosphere) along the scapular neck on three-dimensional (3-D) computed tomography (CT) imaging analysis is predictive of the location of clinical scapular notching that develops following reverse total shoulder arthroplasty (TSA).

Detailed Description
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The Specific Aims are: Determine the relationship between lateral glenoid offset and the development of scapular notching following reverse TSA Determine the ability of 3-D preoperative planning tools to define areas of scapular bony impingement on kinematic simulated shoulder range of motion that predict the development of scapular notching Compare the precision and accuracy of plain radiographs (2-D) versus CT (3-D) for measurement of scapular notching and postoperative implant position following reverse TSA (2-D versus 3-D) Determine the implant and anatomic factors that best correlate with clinical outcome following reverse TSA by retrospective analysis

Official Title
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Prediction of Development of Scapular Notching Based on Glenosphere Positioning, Scapular Morphology, and Simulated Impingement-free Motion Using Three-dimensional Computed Tomography Analysis

Conditions
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Osteoarthritis, Rotator Cuff Tear Arthropathy, Reverse Total Shoulder Arthroplasty, Scapular Notching

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and a minimum of two years out from surgery Exclusion Criteria: All patients having undergone reverse TSA at the Cleveland Clinic with no preoperative CT or a low quality preoperative CT of the operative shoulder and/or less than two years from surgery
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Reverse TSA patients<br>Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actual Versus Predicted Scapular Notching | At minimum 2 year follow-up, compare presence of scapular notching as assessed by 2D x-ray and 3D CT imaging with predicted scapular notching as assessed by 3D computer modeling using video motion analysis of subject range of motion. | At least 24 months after reverse TSA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Pain, Satisfaction and Function (Penn Shoulder Score) | The Penn Shoulder Score is a shoulder-specific patient reported outcome measure. Best possible score is 100; worst possible score is 0. There are 3 sub-scores: pain (3 questions, 30 possible points), satisfaction (1 question, 10 possible points), and function (20 questions, 60 possible points). Total score is the sum of the 3 sub-scores. For all sub-scores, higher is better. The pain questions are based on a 10-point numeric rating scale. Points are added for the pain sub-score. The satisfaction question asks the patient to rate their satisfaction with their shoulder. It is based on a 10-point numeric rating scale, with 0 as not satisfied and 10 as very satisfied. The function sub-score has 20 questions concerning activities of daily living. The response options are: 0 (can't do at all), 1 (can do with much difficulty), 2 (can do with some difficulty) and 3 (can do with no difficulty). If all activities can be done without difficulty, a score of 60 is achieved. | At least 24 months after reverse TSA | 
| Shoulder Strength - Flexion | Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds. | At least 24 months after TSA | 
| Shoulder Strength - Abduction | Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds. | At least 24 months after TSA | 
| Shoulder Strength - Internal Rotation | Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds. | At least 24 months after TSA | 
| Shoulder Strength - External Rotation | Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds. | At least 24 months after TSA | 
| Active Shoulder Range of Motion - Flexion | Flexion | At least 24 months after reverse TSA | 
| Active Shoulder Range of Motion - Abduction | Abduction | At least 24 months after reverse TSA | 
| Active Shoulder Range of Motion - External Rotation | External rotation | At least 24 months after reverse TSA | 
| Passive Shoulder Range of Motion - Flexion | Flexion | At least 24 months after reverse TSA | 
| Passive Shoulder Range of Motion - Abduction | Abduction | At least 24 months after reverse TSA | 
| Passive Shoulder Range of Motion - External Rotation | External rotation | At least 24 months after reverse TSA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder Joint, Computed tomography