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Completed

NCT Number: NCT01697865

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

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).

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Key information

Conditions

Osteoarthritis of the Shoulder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transfer group

Procedure

Control Group

Procedure

Primary outcomes

  1. 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

  1. DASH Score

    Time frame: 1 Year, 2 Year

    Disabilities of the Arm, Shoulder, and Hand score

  2. ASES score

    Time frame: 1 Year, 2 Year

    American Shoulder and Elbow Surgeons Score

  3. SF-12 Score

    Time frame: 1 Year, 2 Year

    General Health Outcome score

  4. Range of Motion

    Time frame: 1 Year, 2 Year

    Shoulder range of motion

  5. X-Ray Measurements

    Time frame: 1 Year, 2 Year

    X-ray measurements from the anteroposterior (AP) and axillary views of the shoulder.

Sponsors and collaborators

Lead sponsor

OrthoCarolina Research Institute, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2020
First posted
Oct 2, 2012
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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