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Completed

NCT Number: NCT03295994

Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears

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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Key information

Age range

40 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged =>40 years to <85 years
  • Shoulder pain and/or loss of range of active motion, strength or function
  • MRI-confirmed partial- or full-thickness supraspinatus and/or infraspinatus tear of 4cm or less in longitudinal dimension
  • Medically fit for surgery, defined as Category I-III per American Society of Anesthesiologists (ASA) Physical Status Classification
  • Ability and willingness to provide informed consent

Exclusion criteria

  • Primary diagnosis is something other than a rotator cuff tear
  • History (in last 2 years) of shoulder fracture involving the humeral head on affected side
  • Previous rotator cuff surgery on affected side
  • Isolated subscapularis &/or teres minor tear on affected side
  • Acute rotator cuff tear caused by a severe trauma
  • Shoulder used as a weight-bearing joint
  • Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.)
  • Glenohumeral osteoarthritis on xrays/MRI, as determined by recruiting MD
  • Grade 4 fatty infiltration of rotator cuff (any tendons)
  • Candidate for shoulder arthroplasty at baseline
  • Non-English speaking
  • Severe problems with maintaining follow-up expected (such as, but not limited to, history of substance abuse, homelessness/incarceration, dementia, brain injury, and psychotic disorders)

Treatment and study plan

Arthroscopic Rotator Cuff Surgery

Procedure

Arthroscopic rotator cuff surgery

physical therapy

Procedure

Physical therapy

Primary outcomes

  1. Shoulder Pain & Disability Index (SPADI)

    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.

Secondary outcomes

  1. American Shoulder and Elbow Surgeons (ASES)

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial

Acronym: ARC

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Sep 28, 2017
Registry last updated
Mar 30, 2026

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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