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

Osteoarthritis of the Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697865
• Other study ID #: 061217B
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Shoulder

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