Status:
TERMINATED
Total vs. Reverse Shoulder Replacement: Pain Relief Two Years After Surgery
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Arthritis
Eligibility:
All Genders
70-95 years
Phase:
NA
Brief Summary
Specific Aim: To compare early postoperative pain relief in patients over the age of 70 who undergo either Total Shoulder Arthroplasty or Reverse Shoulder Arthroplasty in treatment of glenohumeral ost...
Detailed Description
The shoulder is the most mobile joint in the human body with a complex arrangement of structures working together to provide the movement necessary for daily life. Great mobility comes at the expense ...
Eligibility Criteria
Inclusion
- age 70 or older,
- have radiographic signs of osteoarthritis (narrowing of the glenohumeral joint space, marginal osteophytes around the humeral head, progressive changes with sclerosis and subcortical cystic formation and flattening of the humeral head),
- intact rotator cuff but with atrophy or fatty degeneration (defined as Grade II atrophy noted on preoperative shoulder ultrasound),
- objective weakness as measured with Isobex testing,
- limited forward elevation (less than 90 degrees)
Exclusion
- patients who present with pain secondary to inflammatory arthropathy,
- obvious full-thickness rotator cuff tear,
- cuff tear arthropathy,
- revision arthroplasty,
- fracture or trauma,
- patients who had previous rotator cuff repair or prior open surgery prior to shoulder arthroplasty.
- pregnancy
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01884077
Start Date
November 1 2012
End Date
June 1 2016
Last Update
December 5 2018
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110