Post-op Rehabilitation's Influence on Tendon Healing & Clinical Outcomes Following Arthroscopic Rotator Cuff Repair

This study has been completed.
Sponsor:
Collaborator:
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Jay D. Keener, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00756015
First received: September 18, 2008
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to better understand the influence of post-operative rehabilitation on the rate of tendon healing and clinical outcomes following arthroscopic repair of the rotator cuff. There are two schools of thought on what type of therapy program is most beneficial following surgical cuff repair. However there has been little data available to compare them. Therefore, the investigators would like to compare these two standard plans of care so that the investigators may better define the safety and efficacy of early mobilization of the shoulder versus keeping the shoulder immobilized following surgical management.


Condition Intervention
Rotator Cuff Tear
Other: Early Motion Protocol
Other: Immobilization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Healing After Arthroscopic Rotator Cuff Repair: A Prospective, Randomized Trial of Early Range of Motion Versus Immobilization

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Clinical evaluation of Shoulder function and strength [ Time Frame: 3 months, 6 months, 1 year and 2 years post op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of cuff repair integrity using Ultrasound at 1 year post op [ Time Frame: 1 year post op ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: November 2007
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early Motion
Other: Early range of motion post-operative therapy protocol.Early range of motion group: Shoulder pendulum exercises will be allowed from the time of surgery. Immediate range of motion of the elbow, forearm, wrist and hand. At the first postoperative visit, PROM of the shoulder will be permitted under therapist direction. Patients will avoid IR and behind the back stretching. At 6 weeks, AAROM and AROM will be advanced as tolerated. Capsular stretching will be advanced until full range of motion is achieved. Strengthening activities of the rotator cuff, deltoid and scapular stabilizers will be permitted at 3 months post surgery.
Other: Early Motion Protocol
Early range of motion group: Shoulder pendulum exercises will be allowed from the time of surgery. Immediate range of motion of the elbow, forearm, wrist and hand. At the first postoperative visit, PROM of the shoulder will be permitted under therapist direction. Patients will avoid IR and behind the back stretching. At 6 weeks, AAROM and AROM will be advanced as tolerated. Capsular stretching will be advanced until full range of motion is achieved. Strengthening activities of the rotator cuff, deltoid and scapular stabilizers will be permitted at 3 months post surgery.
Other Names:
  • physical therapy
  • early mobilization
Immobilization
Immobilization following rotator cuff repair.
Other: Immobilization
Immobilization group: 6 weeks of sling shoulder immobilization. Immediate range of motion of the elbow, forearm, wrist and hand. At 6 weeks, PROM and stretching of the shoulder allowed under therapist direction. At 12 weeks, AAROM and AROM exercises will be initiated and capsular stretching advanced until full ROM achieved. Strengthening activities of the rotator cuff, deltoid and scapular stabilizers will be permitted at 4 months post surgery.
Other Names:
  • Sling
  • Immobilization
  • Delayed active range of motion

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Full-thickness tears of the rotator cuff involving the supraspinatus that may or may not include the infraspinatus tendon (less than 25 mm anteroposterior dimension)
  2. Arthroscopic double-row cuff repair

Exclusion Criteria:

  1. Acute rotator cuff tears less than 6 weeks from injury
  2. Subscapularis tendon tears (full thickness)
  3. Preoperative stiffness: loss of greater than 30 passive elevation and/or ER compared to the opposite shoulder
  4. Inability to comply with postoperative rehabilitation protocols
  5. Inflammatory disease
  6. Prior surgery of the shoulder
  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: NCT00756015

Locations
United States, Missouri
Washington University School of Medicine - Department of Orthopedics
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Barnes-Jewish Hospital
Investigators
Principal Investigator: Jay Keener, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Jay D. Keener, Assistant Professor Orthopaedic Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00756015     History of Changes
Other Study ID Numbers: HRPO 07-0915
Study First Received: September 18, 2008
Last Updated: October 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
rotator cuff
post-operative immobilization protocol
post-operative early motion protocol
physical therapy
cuff repair integrity
ultrasound

ClinicalTrials.gov processed this record on September 16, 2014