Clinical trial NCT02287090: Comparative Effectiveness of Operative Versus Non-Operative Treatments for Rotator Cuff Tears
Official title: Comparative Effectiveness of Operative Versus Non-Operative Treatments for Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Brigham and Women's Hospital
name: Orthopedic Institute, Sioux Falls, SD
name: University of Texas
First posted: 2014-11-10
Enrollment: 400
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the clinic with rotator cuff tears.

Brief summary: Rotator cuff tears are one of the most common causes of shoulder pain. Evidence-based guidance on optimal diagnostic and treatment strategies for rotator cuff tears is lacking. Our proposed study aims to fill these gaps by identifying the prognostic factors which will predict better outcomes of rotator cuff tears, based on both operative and non-operative treatment. The investigators will also compare outcomes of operative and non-operative treatment of rotator cuff tears and report on the best way to diagnose rotator cuff tears.

Detailed description: Rotator cuff tears account for over one quarter million surgeries annually. They are a leading cause of shoulder pain and disability. Patients with rotator cuff tears present with shoulder pain and/or limitation in range of motion. Fourteen special physical exam tests have been described for diagnosis of rotator cuff tears. Prior literature describing sensitivity and specificity of these tests in diagnosing cuff tears is limited by retrospective design, small sample sizes, samples restricted to patients undergoing surgery, and failure to differentiate between partial and full thickness tears. As a result, there is little evidence to help clinicians interpret the diagnostic value of the clinical exam. Consequently, clinicians rely heavily on magnetic resonance imaging (MRI) for diagnosing cuff tears, adding considerable expense in the diagnostic process.

The treatment options for rotator cuff tears are operative and non-operative. There is currently little consensus on indications and timing of rotator cuff surgery or non-operative treatment. Furthermore, there is lack of evidence-based guidance on factors associated with outcomes of operative versus non-operative treatment for cuff tears.

We are enrolling patients in a prospective cohort study to assess comparative-effectiveness of operative versus non-operative treatment of rotator cuff tears and understand prognostic factors for better outcomes after surgery and non-operative treatments.

Eligibility criteria: Inclusion Criteria:

* Age 45 or older
* Symptoms for at least 4 weeks of shoulder pain and/or limitation in range of motion of shoulder

Exclusion Criteria:

* History of humeral fractures
* Prior surgery on the same shoulder
* Contraindications to MRI (prior surgical hardware, pacemakers, defibrillators, and claustrophobia)
* Unable or unwilling to give informed consent
* Unable or unwilling to be followed up
* Non-English speaking (as questionnaires have only been validated in English)

Primary outcomes:
measure: Pain/Function (as measured by the SPADI outcome score)
timeFrame: 24 months
Secondary outcomes:
measure: Pain/Function (as measured by the ASES outcome score)
timeFrame: 24 months
measure: Pain/Function (as measured by the QuickDash outcome score)
timeFrame: 24 months
measure: Effects of rotator cuff tear size on outcomes (as measured by the SPADI outcome instrument).
timeFrame: 24 months
measure: Effects of patient age on outcomes (as measured by the SPADI outcome instrument).
timeFrame: 24 months
Other outcomes:
measure: Sensitivity/specificity of symptoms and physical exam (compared with MRI and expert clinicians' diagnosis)
timeFrame: 24 months
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Sioux Falls
country: United States
facility: Orthopaedic Institute
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: Vanderbilt University
name: Nitin B Jain, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: