This study is in progress, not accepting new patients

Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears

a study on Rotator Cuff Tear

Summary

Eligibility
for people ages 40-84 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

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 40-84

  • 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

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, as determined by recruiting MD
  • Grade 4 fatty infiltration of rotator cuff (any tendons)
  • Candidate for shoulder arthroplasty at baseline
  • Non-English speaking

Locations

  • UCSF (UCSF)
    San Francisco California 94158 United States
  • Western Orthopaedics
    Denver Colorado 80218 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Texas Southwestern Medical Center
Links
ARC Trial website
ID
NCT03295994
Study Type
Interventional
Participants
About 189 people participating
Last Updated