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

Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction: A Prospective, Randomized Investigation

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).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Shoulder
• Intervention / Treatment: Procedure: Transfer group; Procedure: Control group

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transfer group; The first surgical technique includes a concomitant latissimus and teres major transfer (transfer group).	Procedure: Transfer group
Active Comparator: Control group; The second technique does not include a concomitant latissimus and teres major transfer (control group).	Procedure: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: OrthoCarolina Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2012
• Primary Completion (Actual): February 12, 2019
• Study Completion (Actual): September 21, 2020

Study Registration Dates

• First Submitted: September 27, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Reverse total shoulder
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 061217B