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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Arthrex, Inc.
Information provided by (Responsible Party):
Rosemary A. Sanders, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01383239
First received: June 24, 2011
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Rotator Cuff Tear
Other: Immediate Postoperative Therapy
Other: Delayed Physical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Score of the Western Ontario Rotator Cuff Index(WORC)12 months after surgery. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Study the effect of delaying postoperative physical therapy on patient outcomes using a randomized controlled study design. Patients will be randomized into one of two groups: immediate postoperative therapy versus 6-week delay. The primary outcome variable will be the score of the WORC index 12 months after surgery.


Secondary Outcome Measures:
  • Evaluate postoperatively MR imaging 12 months after surgery. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Identify how delaying postoperative physical therapy may improve healing of rotator cuff repairs as evaluated by postoperative MR imaging 12 months after surgery.


Estimated Enrollment: 214
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate postoperative therapy
Patients will be randomized into one of two groups: immediate postoperative therapy versus 6-week delay
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.
Active Comparator: postoperative therapy delayed for 6 weeks
Patients will be randomized into one of two groups: immediate postoperative therapy versus 6-week delay.
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Age < 18 years
  2. Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder, or previous surgery of the affected shoulder,
  3. Evidence of significant cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations,
  4. Major medical illness (life expectancy < 2 years or unacceptably high operative risk),
  5. Unable to speak or read English,
  6. Psychiatric illness that precludes informed consent,
  7. Unwilling to be followed for 2 years,
  8. Large, massive, or irreparable cuff tears extending into the subscapularis or teres minor,
  9. Inelastic and immobile tendon which cannot be advanced to articular margin,
  10. 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,
  11. Acromioclavicular pathology requiring a distal clavicle excision.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383239

Locations
United States, California
UCSF Sports Medicine
San Francisco, California, United States, 94158
United States, Colorado
CU Sports Medicine
Boulder, Colorado, United States, 80304
United States, Iowa
University Of Iowa
Iowa City, Iowa, United States, 52242
United States, Michigan
University of Michigan, Med Sport
Ann Arbor, Michigan, United States, 48106
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Ohio
OSU Sports Medicine Center
Columbus, Ohio, United States, 43221
United States, Pennsylvania
Penn Orthopaedics
Philadelphia, Pennsylvania, United States, 19104
United States, South Dakota
Sports Medicine & Shoulder Surgery Orthopedic Institute
Sioux Falls, South Dakota, United States, 57117
United States, Tennessee
Shoulder and Elbow Institute of Knoxville
Knoxville, Tennessee, United States, 37922
Sponsors and Collaborators
Vanderbilt University
Arthrex, Inc.
Investigators
Principal Investigator: John E Kuhn, MD Vanderbilt University
Principal Investigator: Warren R Dunn, MD, MPH Vanderbilt University
Principal Investigator: Charles Cox, MD, MPH Vanderbilt Unversity Medical Center
  More Information

No publications provided

Responsible Party: Rosemary A. Sanders, Research Coordinator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01383239     History of Changes
Other Study ID Numbers: #110556, OREF/ASES/Rockwood Grant
Study First Received: June 24, 2011
Last Updated: June 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Rotator Cuff Tear Repair
Rotator Cuff Tear Repair and postoperative treatment

ClinicalTrials.gov processed this record on September 14, 2014