Shoulder Arthritis
Conditions
Brief summary
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
PROCEDUREaTSA
Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo anatomic total shoulder arthroplasty (aTSA) procedure.
PROCEDURErTSA
Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo reverse total shoulder arthroplasty (rTSA) procedure.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) Questionnaire score | 1 year | The American Shoulder and Elbow Surgeons (ASES) score is a self-report survey consisting of a pain scale and activities of daily living section. Total scores range from 0 to 100, where higher scores indicate better shoulder function and less pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale (VAS) Score | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months | The Visual Analog Scale (VAS) is a 1 item self-report survey that asks the subject to rate the level of pain on a scale of 0 (no pain) - 10 (worst imaginable pain). |
| Change in Single Assessment Numeric Evaluation (SANE) Score | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months | The Single Assessment Numeric Evaluation (SANE) is a 2 item self-report survey that asks subjects to rate the percent of normal range on both the affected joint/region and the opposite joint/region. Scores range from 0% - 100%, with 100% indicating normal range. |
| Change in American Shoulder and Elbow Surgeons (ASES) Questionnaire score | Baseline, 6 weeks, 3 months, 6 months, 24 months | The American Shoulder and Elbow Surgeons (ASES) score is a self-report survey consisting of a pain scale and activities of daily living section. Total scores range from 0 to 100, where higher scores indicate better shoulder function and less pain. |
| Change in Shoulder Subjective Value (SSV) Score | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months | The Subjective Shoulder Value (SSV) is 1 item self-report survey that asks subjects to rate their overall shoulder function as a percentage of a "normal" (100%) shoulder. |
| Change in Activities of Daily Living in External Rotation (ADLER) score | Baseline, 1 year | The Activities of Daily Living in External Rotation (ADLER) is a self-report tool used to assess shoulder disability by quantifying a patient's ability to perform 10 specific daily tasks requiring active external rotation. Overall scores range from 0 to 30. Higher maximum scores indicate better functional ability. |
| Change in Activities of Daily Living Includes Internal Rotation (ADLIR) score | Baseline, 1 year | The Activities of Daily Living Includes Internal Rotation (ADLIR) is a self-report tool used to assess shoulder disability by quantifying a patient's ability to perform 9 specific daily tasks requiring active internal rotation. Overall scores range from 14 to 100. Higher maximum scores indicate better functional ability. |
Countries
United States
Contacts
CONTACTLucille I Anderson, CCRP
CONTACTXavier C Gendry
PRINCIPAL_INVESTIGATORJonathan D. Barlow, MD
Mayo Clinic
Outcome results
None listed