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N/A
CT Scans After Shoulder Replacement for Shoulder Osteoarthritis
N/A
Recruiting
Led By April D Armstrong, MD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
primary diagnosis of osteoarthritis of the shoulder
age >45yrs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two year post surgery
Awards & highlights
Summary
This trial aims to study the rotator cuff muscles in the shoulder one and two years after a total shoulder replacement surgery.
Who is the study for?
This trial is for individuals over 45 years old with a primary diagnosis of shoulder osteoarthritis, who had their total shoulder replacement performed by Dr. Armstrong using local anesthetic. Participants must be fluent in English and able to give informed consent.
What is being tested?
The study aims to assess the condition of rotator cuff muscles after total shoulder replacement surgery using CT scans at one and two years post-operation.
What are the potential side effects?
CT scans are generally safe but may include minor side effects such as discomfort from staying still during the scan or reactions to contrast materials if used, like itching or rash.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My primary diagnosis is shoulder osteoarthritis.
Select...
I am older than 45 years.
Select...
I had a total shoulder replacement done by Dr. Armstrong.
Select...
I received a local anesthetic, not regional anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two year post surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two year post surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Denervation
Neuropathic Changes_amplitude
Neuropathic Changes_duration
+3 moreSecondary outcome measures
Fatty atrophy in Rotator Cuff Muscles in both shoulders
Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification
Tear in Rotator Cuff Muscles in both shoulders
Other outcome measures
External Rotation (side) for Active Range of Motion
External Rotation (side) for Passive Range of Motion
Forward Elevation for Active Range of Motion
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: total shoulder replacement surgeryExperimental Treatment1 Intervention
Subjects will be assessed for the outcome measures at one year and two year timepoints post total shoulder replacement surgery
Find a Location
Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
504 Previous Clinical Trials
2,795,910 Total Patients Enrolled
April D Armstrong, MDPrincipal InvestigatorMilton S. Hershey Medical Center
1 Previous Clinical Trials
10 Total Patients Enrolled
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