NCT Number: NCT07584356
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).
Interested in participating?
Request Info60 year–85 year
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Joaquin Sanchez-Sotelo, MD, PhD
SUB_INVESTIGATOR
John Sperling, MD
SUB_INVESTIGATOR
Jonathan D. Barlow, MD
PRINCIPAL_INVESTIGATOR
Lucille I Anderson, CCRP
CONTACT
Mark Morrey, MD, MS
SUB_INVESTIGATOR
Micah Nieboer, MD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo anatomic total shoulder arthroplasty (aTSA) procedure.
Other names: Anatomic total shoulder arthroplasty
Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo reverse total shoulder arthroplasty (rTSA) procedure.
Other names: Reverse total shoulder arthroplasty
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Lucille I Anderson, CCRP
CONTACT
Xavier C Gendry
CONTACT
Mayo Clinic
Other
A Randomized Trial Comparing Anatomic And Reverse Total Shoulder Replacement For Shoulder Arthritis With An Intact Rotator Cuff
Acronym: SOAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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