Arthroscopic Rotator Cuff Surgery
ProcedureArthroscopic rotator cuff surgery
NCT Number: NCT03295994
Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed.
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Notify Me40 year–84 year
All sexes
Interventional
Not applicable
Mayo Clinic, Phoenix, Arizona, United States
This is non-blinded, randomized controlled trial. Patients will be randomly assigned to either an operative or non-operative course of treatment and will be followed for 12 months from baseline.
Aim 1: To compare pain and function in patients undergoing operative versus non-operative treatment of atraumatic rotator cuff tears at 12 months of follow-up
Aim 2: To assess effects of rotator cuff tear size and age on comparative outcomes of operative versus non-operative treatments for atraumatic rotator cuff tears
5U34AR069201-02 NIH grant funded the preparatory work for the trial but not the trial itself.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Arthroscopic rotator cuff surgery
Physical therapy
Time frame: Study participants will be followed for 12 months
SPADI is a composite pain and function measure. The scale range is from 0 to 100, with 0 being best, and 100 being worst.
Time frame: Study participants will be followed for 12 months
ASES is a pain and activity of daily living questionnaire. The range is from 0 to 100, with 0 being worst, and 100 being best.
University of Michigan
Other
Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial
Acronym: ARC
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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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