Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction: A Prospective, Randomized Investigation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- ADLER Score
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Transfer group
The first surgical technique includes a concomitant latissimus and teres major transfer (transfer group).
Intervention: Transfer group (Procedure)
Control group
The second technique does not include a concomitant latissimus and teres major transfer (control group).
Intervention: Control group (Procedure)
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)