Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty

Completed

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

Registration Number: NCT02052466

Lead Sponsor: Eric Ricchetti

Brief Summary: 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: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Actual Versus Predicted Scapular Notching	At least 24 months after reverse TSA	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.

Secondary Outcome Measures

Name	Time	Method
Passive Shoulder Range of Motion - Abduction	At least 24 months after reverse TSA	Abduction
Passive Shoulder Range of Motion - External Rotation	At least 24 months after reverse TSA	External rotation
Shoulder Strength - Internal Rotation	At least 24 months after TSA	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.
Active Shoulder Range of Motion - Flexion	At least 24 months after reverse TSA	Flexion
Active Shoulder Range of Motion - External Rotation	At least 24 months after reverse TSA	External rotation
Active Shoulder Range of Motion - Abduction	At least 24 months after reverse TSA	Abduction
Passive Shoulder Range of Motion - Flexion	At least 24 months after reverse TSA	Flexion
Shoulder Strength - Abduction	At least 24 months after TSA	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.
Shoulder Strength - External Rotation	At least 24 months after TSA	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.
Patient Reported Pain, Satisfaction and Function (Penn Shoulder Score)	At least 24 months after reverse TSA	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.
Shoulder Strength - Flexion	At least 24 months after TSA	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.