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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 50 Years and 84 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Operative
surgery + post-operative physical therapy
  • Procedure: Operative
    Arthroscopic rotator cuff surgery followed by physical therapy.
  • Procedure: Non-Operative
    Physical therapy (without surgery).
Active Comparator
Non-Operative
non-operative physical therapy
  • Procedure: Non-Operative
    Physical therapy (without surgery).

Recruiting Locations

More Details

NCT ID
NCT03295994
Status
Active, not recruiting
Sponsor
Vanderbilt University Medical Center

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.