Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears (ARC)

University of Michigan

Status: Completed

Conditions: Rotator Cuff Tear

Treatments: Procedure: Operative; Procedure: Non-Operative

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03295994

1605-35413 (Other Grant/Funding Number)

171863

Details and patient eligibility

About

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.

Full 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

5U34AR069201-02 NIH grant funded the preparatory work for the trial but not the trial itself.

Enrollment: 189 patients

Sex: All

Ages: 40 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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189 participants in 2 patient groups

Operative

Active Comparator group

Description:

surgery + post-operative physical therapy

Treatment:

Procedure: Operative

Non-Operative

Active Comparator group

Description:

non-operative physical therapy

Treatment:

Procedure: Non-Operative