NCT02052466

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
5 months until next milestone

Results Posted

Study results publicly available

February 23, 2017

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

January 29, 2014

Results QC Date

October 26, 2016

Last Update Submit

May 6, 2017

Conditions

OsteoarthritisRotator Cuff Tear ArthropathyReverse Total Shoulder ArthroplastyScapular Notching

Keywords

Shoulder JointComputed tomography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Patient Reported Pain, Satisfaction and Function (Penn Shoulder Score)

    At least 24 months after reverse TSA

  • Shoulder Strength - Flexion

    At least 24 months after TSA

  • Shoulder Strength - Abduction

    At least 24 months after TSA

  • Shoulder Strength - Internal Rotation

    At least 24 months after TSA

  • Shoulder Strength - External Rotation

    At least 24 months after TSA

  • +6 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related 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.

    PMID: 23473609BACKGROUND

MeSH Terms

Conditions

OsteoarthritisRotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesChondrocalcinosisCrystal Arthropathies

Limitations and Caveats

Relatively small sample size. Range of motion was measured at minimum 2 year follow-up, not pre-operatively.

Results Point of Contact

Title
Dr. Eric Ricchetti
Organization
Cleveland Clinic Foundation
ricchee@ccf.org
2164456915

Study Officials

  • Eric T Ricchetti, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Staff, Orthopaedic Surgery

Study Record Dates

First Submitted

January 29, 2014

First Posted

February 3, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

October 1, 2016

Last Updated

May 9, 2017

Results First Posted

February 23, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)