Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction
1 other identifier
interventional
33
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 21, 2012
CompletedFirst Submitted
Initial submission to the registry
September 27, 2012
CompletedFirst Posted
Study publicly available on registry
October 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2020
CompletedJanuary 25, 2021
January 1, 2021
6.6 years
September 27, 2012
January 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ADLER Score
Activities of Daily Living and External Rotation (ADLER) Score: This tool measures patients' ability to do various tasks on a daily basis.
2 Year
Secondary Outcomes (5)
DASH Score
1 Year, 2 Year
ASES 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 Arms (2)
Transfer group
ACTIVE COMPARATORThe first surgical technique includes a concomitant latissimus and teres major transfer (transfer group).
Control group
ACTIVE COMPARATORThe second technique does not include a concomitant latissimus and teres major transfer (control group).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Revision arthroplasty
- Previous shoulder infection
- Neuro-muscular disorder (ie: Parkinson's)
- Advanced dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2012
First Posted
October 2, 2012
Study Start
June 21, 2012
Primary Completion
February 12, 2019
Study Completion
September 21, 2020
Last Updated
January 25, 2021
Record last verified: 2021-01