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

This study is currently recruiting participants.
Verified September 2017 by OrthoCarolina Research Institute, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01697865
First Posted: October 2, 2012
Last Update Posted: September 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
  Purpose
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).

Condition Intervention
Osteoarthritis of the Shoulder Procedure: Transfer group Procedure: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Further study details as provided by OrthoCarolina Research Institute, Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • DASH Score [ Time Frame: 1 Year, 2 Year ]
    Disabilities of the Arm, Shoulder, and Hand score

  • ASES score [ Time Frame: 1 Year, 2 Year ]
    American Shoulder and Elbow Surgeons Score

  • SF-12 Score [ Time Frame: 1 Year, 2 Year ]
    General Health Outcome score

  • Range of Motion [ Time Frame: 1 Year, 2 Year ]
    Shoulder range of motion

  • X-Ray Measurements [ Time Frame: 1 Year, 2 Year ]
    X-ray measurements from the anteroposterior (AP) and axillary views of the shoulder.


Estimated Enrollment: 42
Study Start Date: October 2012
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transfer group
The first surgical technique includes a concomitant latissimus and teres major transfer (transfer group).
Procedure: Transfer group
Active Comparator: Control group
The second technique does not include a concomitant latissimus and teres major transfer (control group).
Procedure: Control group

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697865


Contacts
Contact: Susan M Odum, MEd 704.323.2265 Susan.Odum@OrthoCarolina.com

Locations
United States, North Carolina
OrthoCarolina Research Institute Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Susan M Odum, MEd    704-323-2265    Susan.Odum@Orthocarolina.com   
Principal Investigator: Nady Hamid, MD         
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
  More Information

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01697865     History of Changes
Other Study ID Numbers: 061217B
First Submitted: September 27, 2012
First Posted: October 2, 2012
Last Update Posted: September 27, 2017
Last Verified: September 2017

Keywords provided by OrthoCarolina Research Institute, Inc.:
Reverse total shoulder

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases