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Orthopedic Implant
Humeral Component Version for Cuff Tear Arthropathy and Rotator Cuff Tears
N/A
Waitlist Available
Led By J. Michael Wiater, MD
Research Sponsored by William Beaumont Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will investigate whether changing the way the humeral component is installed in shoulder surgery impacts range of motion and patient reported functional outcomes.
Eligible Conditions
- Cuff Tear Arthropathy
- Rotator Cuff Tears
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative External Range of Motion (ROM)
Postoperative Internal Range of Motion (ROM)
Trial Design
2Treatment groups
Experimental Treatment
Group I: 30 degrees humeral component retroversionExperimental Treatment1 Intervention
Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion
Group II: 0 degrees humeral component versionExperimental Treatment1 Intervention
Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
0 degrees humeral component version
2017
N/A
~100
30 degrees humeral component retroversion
2017
N/A
~100
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Who is running the clinical trial?
William Beaumont HospitalsLead Sponsor
149 Previous Clinical Trials
112,763 Total Patients Enrolled
J. Michael Wiater, MDPrincipal InvestigatorWilliam Beaumont Hospitals
2 Previous Clinical Trials
244 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are receiving your first reverse total shoulder replacement surgery.You have been diagnosed with cuff tear arthropathy or primary osteoarthritis with rotator cuff tear.You have had surgery on your shoulder in the past that required the area to be cut open.You are not receiving the usual physical therapy treatment.You have undergone a previous joint replacement surgery that needs to be revised.You have rheumatoid arthritis, an infection, or have recently experienced a traumatic injury in the affected area.You have had a surgery called "latissimus dorsi transfer" at the same time as the study.You are pregnant according to what you have told us.You have difficulty thinking or understanding information.
Research Study Groups:
This trial has the following groups:- Group 1: 30 degrees humeral component retroversion
- Group 2: 0 degrees humeral component version
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people still being welcomed into this trial?
"Contrary to expectations, clinicaltrials.gov has revealed that this trial is not presently enrolling patients despite its initial posting on May 12th 2017 and last edit on December 21st 2021. Still, there are 229 other medical trials open for recruitment right now."
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