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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01697865
Other study ID # 061217B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 21, 2012
Est. completion date September 21, 2020

Study information

Verified date January 2021
Source OrthoCarolina Research Institute, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overall objective of this study is to compare the clinical benefit and safety of two different surgical techniques of primary reverse total shoulder arthroplasty for the treatment of shoulder pseudoparalysis from chronic rotator cuff disease with associated teres minor dysfunction. The first surgical technique includes a concomitant latissimus and teres major transfer (transfer group) and the second technique does not include a concomitant latissimus and teres major transfer (control group).


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date September 21, 2020
Est. primary completion date February 12, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Shoulder pseudoparalysis due to chronic rotator cuff dysfunction with or without glenohumeral arthritis. - Chronic rotator cuff tear with severe retraction, atrophy, fatty infiltration. - Active forward elevation of less than 90 degrees - Teres minor dysfunction - Positive lag and hornblower sign - Grade 2 or greater fatty infiltration of the teres minor and infraspinatous seen on MRI - Able to attend scheduled office visits - Meet all criteria to have a latissimus and teres major transfer Exclusion Criteria: - Revision arthroplasty - Previous shoulder infection - Neuro-muscular disorder (ie: Parkinson's) - Advanced dementia

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Transfer group

Control group


Locations

Country Name City State
United States OrthoCarolina Research Institute Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
OrthoCarolina Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary ADLER Score Activities of Daily Living and External Rotation (ADLER) Score: This tool measures patients' ability to do various tasks on a daily basis. 2 Year
Secondary DASH Score Disabilities of the Arm, Shoulder, and Hand score 1 Year, 2 Year
Secondary ASES score American Shoulder and Elbow Surgeons Score 1 Year, 2 Year
Secondary SF-12 Score General Health Outcome score 1 Year, 2 Year
Secondary Range of Motion Shoulder range of motion 1 Year, 2 Year
Secondary X-Ray Measurements X-ray measurements from the anteroposterior (AP) and axillary views of the shoulder. 1 Year, 2 Year
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