Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty

NCT ID: NCT02052466

Last Updated: 2017-05-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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

Conditions

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Osteoarthritis Rotator Cuff Tear Arthropathy Reverse Total Shoulder Arthroplasty Scapular Notching

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eric Ricchetti

OTHER

Sponsor Role lead

Responsible Party

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Eric Ricchetti

Staff, Orthopaedic Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Eric T Ricchetti, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23473609 (View on PubMed)

Other Identifiers

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12-1244

Identifier Type: -

Identifier Source: org_study_id

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