Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs

Completed · Not applicable

Conditions studied: Rotator Cuff Tear

In brief

Rotator cuff tears are seen in 40% of subjects over age 50 57, with a prevalence known to increase with each decade of life 51. Each year rotator cuff disorders lead to 4.5 million physician visits, 40,000 inpatient surgeries, and 250,000 outpatient surgeries with costs of $17,427 per patient in 2004. As the population ages, the number of rotator cuff repair surgeries is increasing; in New York State, rotator cuff repairs increased by 50% over a 5 years span 48. Unfortunately, surgically repaired rotator cuff tears fail in at least 20% and up to 94% of individuals 3, 9, 13, 20, 28, 40, 52, 58. While many non-modifiable variables have been associated with failure of repair, postoperative rehabilitation is a modifiable variable that has received little attention. The investigators propose a multicenter randomized controlled trial to study one important strategy for postoperative rehabilitation: early versus delayed onset of physical therapy. This pilot study will enroll patients with isolated supraspinatus tears who undergo a standard surgical repair technique. The investigators hypothesize that delaying the onset of physical therapy will improve healing and patient outcomes. Our primary outcome variable is the Western Ontario Rotator Cuff (WORC) Index (a disease specific validated outcome measure). Because outcome measures may not always correlate with healing of rotator cuff repairs 50, our secondary outcome measure will be healing based on MRI scans 12 months after surgery.

Key facts

Study ID: NCT01383239
Run by: Vanderbilt University
People needed: 27
Starts: 2011-09-01
Expected to finish: 2016-07-01
Last updated by the study team: 2016-11-04

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Patients for inclusion based on MRI documented full thickness supraspoinatus tear with acute tears, or chronic tears that fail non-operative therapy.
Tears that involve the supraspinatus and are minimally displaced (Grade I) or displaced to the humeral head (Grade II) will be included

You may not qualify if…

Age < 18 years
Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder, or previous surgery of the affected shoulder,
Evidence of significant cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations,
Major medical illness (life expectancy < 2 years or unacceptably high operative risk),
Unable to speak or read English,
Psychiatric illness that precludes informed consent,
Unwilling to be followed for 2 years,
Large, massive, or irreparable cuff tears extending into the subscapularis or teres minor,
Inelastic and immobile tendon which cannot be advanced to articular margin,
Co-existing labral pathologies requiring repair (SLAP II-IV), Bankart lesions requiring repair, partial tears of biceps (more than 60% of thickness) requiring surgical treatment,
Acromioclavicular pathology requiring a distal clavicle excision.

Where it is running

UCSF Sports Medicine — San Francisco, California, United States
CU Sports Medicine — Boulder, Colorado, United States
University Of Iowa — Iowa City, Iowa, United States
University of Michigan, Med Sport — Ann Arbor, Michigan, United States
Washington University School of Medicine — St Louis, Missouri, United States
OSU Sports Medicine Center — Columbus, Ohio, United States
Penn Orthopaedics — Philadelphia, Pennsylvania, United States
Sports Medicine & Shoulder Surgery Orthopedic Institute — Sioux Falls, South Dakota, United States
Shoulder and Elbow Institute of Knoxville — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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