A Study Comparing Shoulder Replacement Techniques For Patients With Shoulder Arthritis And An Intact Rotator Cuff
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: aTSA, rTSA.
- Who it may be relevant to
- Registry conditions: Shoulder Arthritis. Basic parameters: 60 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Trial Comparing Anatomic And Reverse Total Shoulder Replacement For Shoulder Arthritis With An Intact Rotator Cuff
Overview
The purpose of this study is to determine if patients undergoing anatomic total shoulder arthroplasty (aTSA) will have improved patient reported outcome scores at 1 year compared to those undergoing reverse total shoulder arthroplasty (rTSA).
Interventions
- Procedure aTSA
Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo anatomic total shoulder arthroplasty (aTSA) procedure. - Procedure rTSA
Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo reverse total shoulder arthroplasty (rTSA) procedure.
Primary outcome measures
- American Shoulder and Elbow Surgeons (ASES) Questionnaire score [Time frame: 1 year]
Secondary outcome measures (6)
- Change in Visual Analog Scale (VAS) Score [Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months]
- Change in Single Assessment Numeric Evaluation (SANE) Score [Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months]
- Change in American Shoulder and Elbow Surgeons (ASES) Questionnaire score [Time frame: Baseline, 6 weeks, 3 months, 6 months, 24 months]
- Change in Shoulder Subjective Value (SSV) Score [Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months]
- Change in Activities of Daily Living in External Rotation (ADLER) score [Time frame: Baseline, 1 year]
- Change in Activities of Daily Living Includes Internal Rotation (ADLIR) score [Time frame: Baseline, 1 year]
Eligibility criteria
Inclusion criteria
- Shoulder arthritis
- Intact rotator cuff
- Glenoid retroversion less than 25°
Exclusion criteria
- Rotator cuff insufficiency
- Fracture deformity/sequelae
- Severe glenoid deformity (C glenoid, severe A2, B2 glenoid)
- Current or previous infection of shoulder
- Previous acromion fracture (not os acromiale)
- Brachial plexopathy
- Axillary neuropathy
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
- Medical conditions that would make 2 years follow up unlikely
- Non-English speaking
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07584356 · 26-002449