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

Summary

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.

Conditions

• Rotator Cuff Tear

Interventions

OTHER

Immediate Postoperative Therapy

All patients will undergo a 16 week postoperative therapy program (a formal physical therapy program, a home exercise program or a combination of both). Immediate and delayed therapy are the current standard of care for postoperative physical therapy. The Immediate group will began physical therapy 3-7 days postoperatively.

OTHER

Delayed Physical Therapy

All patients will undergo a 16 week postoperative therapy program (a formal physical therapy program, a home exercise program or a combination of both). Immediate and delayed therapy are the current standard of care for postoperative physical therapy. The delayed group will began physical therapy 6 weeks postoperatively

Sponsors & Collaborators

• Arthrex, Inc.

  collaborator INDUSTRY

• Vanderbilt University

  lead OTHER

Principal Investigators

• John E Kuhn, MD · Vanderbilt University Medical Center

• Warren R Dunn, MD, MPH · Vanderbilt University Medical Center

• Charles Cox, MD, MPH · Vanderbilt Unversity Medical Center

Study Design

Allocation

RANDOMIZED

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2016-06-30

Completion

2016-07-31

Countries

• United States

Study Locations