Summary

for people ages 50-84 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
C. Benjamin Ma

Description

Summary

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.

Official Title

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

Details

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

Keywords

Rotator Cuff Tear arthroscopy physical therapy rehabilitation surgery Rotator Cuff Injuries Operative Non-Operative

Eligibility

You can join if…

Open to people ages 50-84

  • Aged =>50 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

You CAN'T join if...

  • 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
  • Grade 4 fatty infiltration of rotator cuff (any tendons)
  • Candidate for shoulder arthroplasty at baseline
  • Non-English speaking

Locations

  • University of California - San Francisco (UCSF) accepting new patients
    San Francisco California 94158 United States
  • University of Colorado - Denver not yet accepting patients
    Denver Colorado 80222 United States
  • Orthopedic Institute accepting new patients
    Sioux Falls South Dakota 57105 United States
  • University of Texas Southwestern accepting new patients
    Dallas Texas 75390 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vanderbilt University Medical Center
Links
ARC Trial website
ID
NCT03295994
Lead Scientist
C. Benjamin Ma
Study Type
Interventional
Last Updated
July 1, 2018