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. (see Contacts and Locations)
Verified July 2014 by OrthoCarolina Research Institute, Inc.
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01697865
First received: September 27, 2012
Last updated: July 15, 2014
Last verified: July 2014
  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 Phase
Osteoarthritis of the Shoulder
Procedure: Transfer group
Procedure: Control group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • ADLER Score [ Time Frame: 2 Year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Disabilities of the Arm, Shoulder, and Hand score

  • ASES score [ Time Frame: 1 Year, 2 Year ] [ Designated as safety issue: No ]
    American Shoulder and Elbow Surgeons Score

  • SF-12 Score [ Time Frame: 1 Year, 2 Year ] [ Designated as safety issue: No ]
    General Health Outcome score

  • Range of Motion [ Time Frame: 1 Year, 2 Year ] [ Designated as safety issue: No ]
    Shoulder range of motion

  • X-Ray Measurements [ Time Frame: 1 Year, 2 Year ] [ Designated as safety issue: No ]
    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 2018
Estimated Primary Completion Date: October 2017 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01697865     History of Changes
Other Study ID Numbers: 061217B
Study First Received: September 27, 2012
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 27, 2014