Status:
UNKNOWN
TSA Versus RSA in Patients >75
Lead Sponsor:
Rothman Institute Orthopaedics
Conditions:
Total Shoulder Arthoplasty
Eligibility:
All Genders
75+ years
Phase:
NA
Brief Summary
Total shoulder arthroplasty (TSA) has proven to be a predictable and successful operation for the treatment of symptomatic glenohumeral osteoarthritis (GHOA) with an intact rotator cuff. Results after...
Eligibility Criteria
Inclusion
- All patients (75 years of age) at the time of surgery
- 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
- Patients under the age of 75
- 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.
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2022
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04827277
Start Date
April 15 2021
End Date
April 15 2022
Last Update
April 1 2021
Active Locations (1)
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1
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107