Osteoarthritis of the Shoulder Clinical Trial
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
Verified date | January 2021 |
Source | OrthoCarolina Research Institute, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 33 |
Est. completion date | September 21, 2020 |
Est. primary completion date | February 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | OrthoCarolina Research Institute | Charlotte | North Carolina |
Lead Sponsor | Collaborator |
---|---|
OrthoCarolina Research Institute, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | DASH Score | Disabilities of the Arm, Shoulder, and Hand score | 1 Year, 2 Year | |
Secondary | ASES score | American Shoulder and Elbow Surgeons Score | 1 Year, 2 Year | |
Secondary | SF-12 Score | General Health Outcome score | 1 Year, 2 Year | |
Secondary | Range of Motion | Shoulder range of motion | 1 Year, 2 Year | |
Secondary | X-Ray Measurements | X-ray measurements from the anteroposterior (AP) and axillary views of the shoulder. | 1 Year, 2 Year |
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