Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052466
• Other study ID #: 12-1244
• Status: Completed
• Phase: N/A
• First received: January 29, 2014
• Last updated: May 6, 2017
• Start date: January 2014
• Est. completion date: October 2016

Study information

• Verified date: May 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Reverse Total Shoulder Arthroplasty
• Rotator Cuff Tear Arthropathy
• Scapular Notching

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Eric Ricchetti

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	At least 24 months after reverse TSA
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.	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.	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.	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.	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.	At least 24 months after TSA
Secondary	Active Shoulder Range of Motion - Flexion	Flexion	At least 24 months after reverse TSA
Secondary	Active Shoulder Range of Motion - Abduction	Abduction	At least 24 months after reverse TSA
Secondary	Active Shoulder Range of Motion - External Rotation	External rotation	At least 24 months after reverse TSA
Secondary	Passive Shoulder Range of Motion - Flexion	Flexion	At least 24 months after reverse TSA
Secondary	Passive Shoulder Range of Motion - Abduction	Abduction	At least 24 months after reverse TSA
Secondary	Passive Shoulder Range of Motion - External Rotation	External rotation	At least 24 months after reverse TSA