Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
108 participants
INTERVENTIONAL
2021-04-15
2022-04-15
Brief Summary
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Advanced age has been shown to be associated with increased fatty infiltration of the rotator cuff in shoulders with primary osteoarthritis. Because of this, one may propose that surgeons should avoid the potential complications with TSA and perform RSA for patients with advanced age. It is thus the purpose of this study to evaluate the patient reported outcomes (PROs) of total shoulder arthroplasty (TSA) compared with reverse shoulder arthroplasty (RSA) in patients \>75 years of age
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Reverse total shoulder replacement
Participants will receive a reverse total shoulder arthroplasty
Reverse Total Shoulder Replacement
Participants will be randomized to a reverse total shoulder replacement
Anatomic total shoulder replacement
Participants will receive an anatomic total shoulder arthroplasty
Anatomic Total Shoulder Replacement
Participants will be randomized to an anatomic total shoulder replacement
Interventions
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Reverse Total Shoulder Replacement
Participants will be randomized to a reverse total shoulder replacement
Anatomic Total Shoulder Replacement
Participants will be randomized to an anatomic total shoulder replacement
Eligibility Criteria
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Inclusion Criteria
* Patient is willing to participate by complying with pre and postoperative visit requirements
* Patient is willing to consent for enrollment
* Patient has advanced imaging (CT or MRI) that demonstrates an intact rotator cuff
Exclusion Criteria
* Need for any structural graft for repair of the shoulder during surgery
* Current infection of the proximal humerus or scapula
* Proximal humerus fracture
* Inadequate or malformed bone that precludes adequate support for prosthesis (B2, B3, C Glenoid morphology)
* Neuromuscular disorder that does not allow control of the shoulder joint
* Significant injury to the brachial plexus
* Diagnosis of inflammatory arthropathy
* Preoperative diagnosis of full thickness rotator cuff tear
* \>Goutallier Stage 1 rotator cuff atrophy
* Prior shoulder arthroplasty
* Non-functioning deltoid muscle
* Patients who are known drug or alcohol abuser, or have a psychological disorder as defined by the DSM4 that could affect follow-up care
* Patient is a prisoner
* Patients who are currently involved in any personal injury litigation, or worker's compensation claims.
75 Years
ALL
Yes
Sponsors
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Rothman Institute Orthopaedics
OTHER
Responsible Party
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Locations
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Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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JABB20D.949
Identifier Type: -
Identifier Source: org_study_id
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