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NCT03617107 Clinical Trial

Reverse Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing Reverse Total Shoulder Arthroplasty

Rotator Cuff Tear Clinical Trial

— rTSA  

Official title:
Reverse Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing Reverse Total Shoulder Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03617107
Other study ID # ORIF.004
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 15, 2017
Est. completion date December 31, 2020

Study information
Verified date October 2019
Source The Orthopaedic Research & Innovation Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate reverse total shoulder arthroplasty patients preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date December 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. English speaking

2. >18 years of age

3. Reverse TSA performed by principal investigator

Exclusion Criteria:

1. Non-English speaking

2. <18 years of age

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• reverse total shoulder arthroplasty
reverse total shoulder arthroplasty

Locations
Country Name City State
United States The Orthopaedic Research & Innovation Foundation Edgewood Kentucky

Sponsors (1)
Lead Sponsor Collaborator
The Orthopaedic Research & Innovation Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary total operative time minutes preoperative to up to 8 years postoperative
Primary amount of blood loss mls preoperative to up to 8 years postoperative
Secondary Patient Outcomes American Shoulder and Elbow Surgeon score to measure shoulder function and pain. Scale of 0-100, 100 being the best possible score preoperative to up to 8 years postoperative
Secondary Patient Outcomes Simple Shoulder Test score to measure shoulder function. Scale from 0-12, 12 being the most functional. preoperative to up to 8 years postoperative
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