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

  Hide Detailed Description

Detailed Description:

Surgically repaired rotator cuff tears fail at surprisingly high rates, approaching 20-94% as determined by MRI 3, 9, 13, 20, 28, 40, 52, 58. Non-modifiable variables associated with rotator cuff repair failure include: duration of symptoms 9, 19, 39, fatty infiltration of the atrophied muscle 6, 15, 17, larger rotator cuff tears 6, 9, 19, 20, 21, 26, 39, 47, older age 9, 20, 22, 48, 55, co-morbidities 48, and workers compensation claims 2, 22, 23. Potentially modifiable variables include: tobacco use 11, 38, limited preoperative range of motion 45, and surgeon volume 48.

Two other modifiable variables are surgical technique and postoperative management. As advances in arthroscopic techniques have evolved, a variety of studies have evaluated different surgical techniques in clinical series and trials 3, 4, 20, 12, 18, 31, 36. In 2006, Park et al described the "transosseous equivalent" repair technique characterized by sutures secured medially, passed through and over the top of the rotator cuff, and then secured laterally 44. This method of repair has been shown to have better biomechanical properties and produce superior healing rates compared to other techniques in randomized clinical trials 5, 12. These data suggest this technique is currently the best available method to repair rotator cuff tears.

Postoperative management of patients who have had rotator cuff repair has received little attention in the literature, yet is likely one of the most important modifiable variables that can influence rotator cuff repair integrity. It has been argued that early physical therapy may increase failure rates of rotator cuff repair 1, 14. This has led some to recommend delaying therapy for up to 6 weeks after surgery.

Three groups have studied delaying the onset of physiotherapy in patients with full thickness rotator cuff tears. Klintberg et al 29 performed a randomized trial on patients who underwent open rotator cuff repair comparing two postoperative physical therapy protocols: a "Progressive Therapy Group" ¬ (started the day after surgery with passive range of motion and dynamic muscle activation of the rotator cuff, a sling was removed after 4 weeks and rotator cuff loading was progressive through the rehabilitation), and a "Traditional Group" (passive range of motion the day after surgery with immobilization in a sling for 6 weeks during which time no rotator cuff loading was applied). In this trial no significant differences in outcome were detected.

In contrast to this, Deutsch et al 7 reported on 70 patients who had a single row arthroscopic rotator cuff repair with simple suture configuration randomized to one of two physical therapy protocols that were different only in that the "Standard" protocol began passive forward elevation on postoperative day 7 (N=37), whereas the "Delayed" protocol began passive forward elevation after 4 weeks (N=33). At 6 months range of motion was not different, however ultrasound examination demonstrated 19% of the repairs failed in the "Standard" group, whereas only 9% failed in the "Delayed" group (p<0.05).

In a prospective cohort study presented by Accousti et al 1, 56 patients were all managed by 6 weeks of immobilization following rotator cuff repair. When immobilization was removed, 13 patients were considered "stiff" with limited motion, and 43 had "good" passive motion. By one year none of the patients were considered stiff. In the "stiff" group rotator cuff repairs failed in 30%, whereas in the group with "good" motion at six weeks 62% of repairs failed.

These data, while limited, suggest that some period of immobilization may improve healing of rotator cuff repairs. The effect of immobilization on other measures of outcome is unclear. Unfortunately none of these studies used the transosseous equivalent repair technique.

The purpose of this study is to compare two different strategies of postoperative management in patients with isolated supraspinatus rotator cuff tears repaired with a standardized "SpeedBridge" arthroscopic transosseous equivalent technique, using a disease specific validated measure of outcome (WORC index) as the primary outcome variable. The design will be a multicenter randomized trial comparing immediate to delayed physical therapy. As patient oriented outcomes frequently do not correlate with rotator cuff repair healing 50, the second aim is to study the effect of these rehabilitation paradigms on rotator cuff healing by MRI.

  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
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 April 17, 2014