Clinical trial NCT02052466: Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Rotator Cuff Tear Arthropathy
Reverse Total Shoulder Arthroplasty
Scapular Notching
Keywords: Shoulder Joint
Computed tomography
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Actual Versus Predicted Scapular Notching
timeFrame: At least 24 months after reverse TSA
Secondary outcomes:
measure: Patient Reported Pain, Satisfaction and Function (Penn Shoulder Score)
timeFrame: At least 24 months after reverse TSA
measure: Shoulder Strength - Flexion
timeFrame: At least 24 months after TSA
measure: Shoulder Strength - Abduction
timeFrame: At least 24 months after TSA
measure: Shoulder Strength - Internal Rotation
timeFrame: At least 24 months after TSA
measure: Shoulder Strength - External Rotation
timeFrame: At least 24 months after TSA
measure: Active Shoulder Range of Motion - Flexion
timeFrame: At least 24 months after reverse TSA
measure: Active Shoulder Range of Motion - Abduction
timeFrame: At least 24 months after reverse TSA
measure: Active Shoulder Range of Motion - External Rotation
timeFrame: At least 24 months after reverse TSA
measure: Passive Shoulder Range of Motion - Flexion
timeFrame: At least 24 months after reverse TSA
measure: Passive Shoulder Range of Motion - Abduction
timeFrame: At least 24 months after reverse TSA
measure: Passive Shoulder Range of Motion - External Rotation
timeFrame: At least 24 months after reverse TSA
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Eric T Ricchetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.