Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty

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

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).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Rotator Cuff Tear Arthropathy; Reverse Total Shoulder Arthroplasty; Scapular Notching

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

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eric Ricchetti
• Investigators: Principal Investigator: Eric T Ricchetti, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 29, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 6, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Computed tomography; Shoulder Joint
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Arthritis; Rupture; Shoulder Injuries; Tendon Injuries; Crystal Arthropathies; Chondrocalcinosis; Rotator Cuff Injuries; Rotator Cuff Tear Arthropathy
• Other Study ID Numbers: 12-1244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO