Completed

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

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What is being tested

Transfer group

+ Control group

Procedure
Who is being recruted

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2012
See protocol details

Summary

Principal SponsorOrthoCarolina Research Institute, Inc.
Last updated: January 25, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: June 21, 2012

Actual date on which the first participant was enrolled.

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).

NCT01697865
Principal SponsorOrthoCarolina Research Institute, Inc.
Last updated: January 25, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

33 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 inclusion criteria required to participate
Able to attend scheduled office visits
Active forward elevation of less than 90 degrees
Chronic rotator cuff tear with severe retraction, atrophy, fatty infiltration
Grade 2 or greater fatty infiltration of the teres minor and infraspinatous seen on MRI
Show More Criteria
4 exclusion criteria prevent from participating
Advanced dementia
Neuro-muscular disorder (ie: Parkinson's)
Previous shoulder infection
Revision arthroplasty

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
The first surgical technique includes a concomitant latissimus and teres major transfer (transfer group).

Group II

Active Comparator
The second technique does not include a concomitant latissimus and teres major transfer (control group).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

OrthoCarolina Research Institute

Charlotte, United StatesOpen OrthoCarolina Research Institute in Google Maps
CompletedOne Study Center