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

NCT01383239 | Completed

• 2 other identifiers: #110556OREF/ASES/Rockwood Grant
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

Rotator Cuff Tear Repair; Rotator Cuff Tear Repair and postoperative treatment

Outcome Measures

Primary Outcomes (1)

• Score of the Western Ontario Rotator Cuff Index(WORC)12 months after surgery.

  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.

  12 months

Secondary Outcomes (1)

• Evaluate postoperatively MR imaging 12 months after surgery.

  12 months

Study Arms (2)

Immediate postoperative therapy

ACTIVE COMPARATOR

Patients will be randomized into one of two groups: immediate postoperative therapy versus 6-week delay

Other: Immediate Postoperative Therapy

postoperative therapy delayed for 6 weeks

ACTIVE COMPARATOR

Patients will be randomized into one of two groups: immediate postoperative therapy versus 6-week delay.

Other: Delayed Physical Therapy

Interventions

Immediate Postoperative Therapy OTHER

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.

Immediate postoperative therapy

Delayed Physical Therapy OTHER

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

postoperative therapy delayed for 6 weeks

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• Arthrex, Inc.: collaborator

Study Sites (9)

UCSF Sports Medicine

San Francisco, California, 94158, United States

Location

CU Sports Medicine

Boulder, Colorado, 80304, United States

Location

University Of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Michigan, Med Sport

Ann Arbor, Michigan, 48106, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

OSU Sports Medicine Center

Columbus, Ohio, 43221, United States

Location

Penn Orthopaedics

Philadelphia, Pennsylvania, 19104, United States

Location

Sports Medicine & Shoulder Surgery Orthopedic Institute

Sioux Falls, South Dakota, 57117, United States

Location

Shoulder and Elbow Institute of Knoxville

Knoxville, Tennessee, 37922, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• John E Kuhn, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Warren R Dunn, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Charles Cox, MD, MPH

  Vanderbilt Unversity Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 28, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 4, 2016

Record last verified: 2016-11

Locations

US (9)