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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).
The Specific Aims are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reverse TSA patients | 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. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who had a reverse Total Shoulder Arthroplasty at the Cleveland Clinic from 2004 to 2011 and who had a high quality preoperative CT scan.
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| Name | Affiliation | Role |
|---|---|---|
| Eric T Ricchetti, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23473609 | Background | Iannotti JP, Ricchetti ET, Rodriguez EJ, Bryan JA. Development and validation of a new method of 3-dimensional assessment of glenoid and humeral component position after total shoulder arthroplasty. J Shoulder Elbow Surg. 2013 Oct;22(10):1413-22. doi: 10.1016/j.jse.2013.01.005. Epub 2013 Mar 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reverse TSA Patients | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reverse TSA Patients | Patients having undergone reverse Total Shoulder Arthroplasty (TSA) at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Patients who had video motion analysis of their range of motion at minimum 2 year follow-up | Posted | Number | percentage of accurate predictions | At least 24 months after reverse TSA |
|
Minimum 2 years after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reverse TSA Patients | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip fracture due to fall | Musculoskeletal and connective tissue disorders | EPIC | Non-systematic Assessment | Treated surgically with hip hemiarthroplasty |
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Relatively small sample size. Range of motion was measured at minimum 2 year follow-up, not pre-operatively.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Ricchetti | Cleveland Clinic Foundation | 2164456915 | ricchee@ccf.org |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D000070656 | Rotator Cuff Tear Arthropathy |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Scores on the Penn Shoulder Score scale | At least 24 months after reverse TSA |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | pounds | At least 24 months after TSA |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | pounds | At least 24 months after TSA |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | pounds | At least 24 months after TSA |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | pounds | At least 24 months after TSA |
|
|
|
| Secondary | Active Shoulder Range of Motion - Flexion | Flexion | Posted | Mean | Standard Deviation | Degrees | At least 24 months after reverse TSA |
|
|
|
| Secondary | Active Shoulder Range of Motion - Abduction | Abduction | Posted | Mean | Standard Deviation | Degrees | At least 24 months after reverse TSA |
|
|
|
| Secondary | Active Shoulder Range of Motion - External Rotation | External rotation | Posted | Mean | Standard Deviation | Degrees | At least 24 months after reverse TSA |
|
|
|
| Secondary | Passive Shoulder Range of Motion - Flexion | Flexion | Posted | Mean | Standard Deviation | Degrees | At least 24 months after reverse TSA |
|
|
|
| Secondary | Passive Shoulder Range of Motion - Abduction | Abduction | Posted | Mean | Standard Deviation | Degrees | At least 24 months after reverse TSA |
|
|
|
| Secondary | Passive Shoulder Range of Motion - External Rotation | External rotation | Posted | Mean | Standard Deviation | Degrees | At least 24 months after reverse TSA |
|
|
|
| 6 |
| 30 |
| 0 |
| 30 |
|
| Fracture of acromion | Musculoskeletal and connective tissue disorders | EPIC | Non-systematic Assessment | Minimally displaced fracture of acromion due to motor vehicle accident. Treated surgically with Open Reduction, Internal Fixation. |
|
| A-fib with rapid ventricular response | Cardiac disorders | EPIC | Non-systematic Assessment |
|
| Transient ischemic attack | Cardiac disorders | EPIC | Non-systematic Assessment |
|
| Bladder tumor | Renal and urinary disorders | EPIC | Non-systematic Assessment | Transurethral bladder resection |
|
| Pneumonia | Infections and infestations | EPIC | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | EPIC | Non-systematic Assessment | Lower extremity cellulitis |
|
| External artery, common femoral, and profunda endarterectomy | Vascular disorders | EPIC | Non-systematic Assessment | Peripheral vascular disease with lymphoma and claudication |
|
| Thiamine deficiency | Metabolism and nutrition disorders | EPIC | Non-systematic Assessment | Altered mental state |
|
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| D002805 |
| Chondrocalcinosis |
| D000070657 | Crystal Arthropathies |