Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction

Not Applicable

Completed

• Conditions: Osteoarthritis of the Shoulder
• Interventions: Procedure: Control group; Procedure: Transfer group

• Registration Number: NCT01697865
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-21
• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-02
• Primary Completion: 2019-02-12
• Study Completion: 2020-09-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

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Exclusion Criteria

• Revision arthroplasty
• Previous shoulder infection
• Neuro-muscular disorder (ie: Parkinson's)
• Advanced dementia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	The second technique does not include a concomitant latissimus and teres major transfer (control group).
Transfer group	Transfer group	The first surgical technique includes a concomitant latissimus and teres major transfer (transfer group).

Primary Outcome Measures

Name	Time	Method
ADLER Score	2 Year	Activities of Daily Living and External Rotation (ADLER) Score: This tool measures patients' ability to do various tasks on a daily basis.

Secondary Outcome Measures

Name	Time	Method
ASES score	1 Year, 2 Year	American Shoulder and Elbow Surgeons Score
DASH Score	1 Year, 2 Year	Disabilities of the Arm, Shoulder, and Hand score
SF-12 Score	1 Year, 2 Year	General Health Outcome score
Range of Motion	1 Year, 2 Year	Shoulder range of motion
X-Ray Measurements	1 Year, 2 Year	X-ray measurements from the anteroposterior (AP) and axillary views of the shoulder.

Trial Locations

Locations (1)

OrthoCarolina Research Institute; 🇺🇸 Charlotte, North Carolina, United States