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

NCT ID: NCT01697865

Last Updated: 2021-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-21

Study Completion Date

2020-09-21

Brief Summary

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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

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Conditions

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Osteoarthritis of the Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Transfer group

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

Group Type ACTIVE_COMPARATOR

Transfer group

Intervention Type PROCEDURE

Control group

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

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type PROCEDURE

Interventions

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Transfer group

Intervention Type PROCEDURE

Control group

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OrthoCarolina Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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OrthoCarolina Research Institute

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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061217B

Identifier Type: -

Identifier Source: org_study_id

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