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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02052466
Other study ID # 12-1244
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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