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Clinical Trials/NCT01697865
NCT01697865
Completed
Not Applicable

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

OrthoCarolina Research Institute, Inc.1 site in 1 country33 target enrollmentJune 21, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis of the Shoulder
Sponsor
OrthoCarolina Research Institute, Inc.
Enrollment
33
Locations
1
Primary Endpoint
ADLER Score
Status
Completed
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 21, 2012
End Date
September 21, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

ADLER Score

Time Frame: 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 Outcomes

  • ASES score(1 Year, 2 Year)
  • DASH Score(1 Year, 2 Year)
  • SF-12 Score(1 Year, 2 Year)
  • Range of Motion(1 Year, 2 Year)
  • X-Ray Measurements(1 Year, 2 Year)

Study Sites (1)

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