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Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter MacDonald, Panam Clinic
ClinicalTrials.gov Identifier:
NCT00290888
First received: February 10, 2006
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

Surgical repair of full thickness tears of the rotator cuff is a controversial issue, with several procedures currently being used to treat the tear. The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty. However, an arthroscopic cuff repair without acromioplasty may offer the same degree of improvement as one that includes acromioplasty, but without threatening the shoulder stability that is provided by the acromion and coracoacromial ligament. This prospective study examines the hypothesis that appropriate shoulder function can be restored through the execution of the traditional arthroscopic cuff repair without acromioplasty.


Condition Intervention
Rotator Cuff Tear
Shoulder Impingement Syndrome
 Procedure: Acromioplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Panam Clinic:

Primary Outcome Measures:
  • Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • American Shoulder and Elbow Surgeons standardized form for the assessment of the shoulder (ASES) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Shoulder range of motion [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Upper extremity strength grading [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: April 2004
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACR
Arthroscopic rotator cuff repair without acromioplasty
 Procedure: Acromioplasty
Experimental: ACR-A
Arthorscopic rotator cuff repair with acromioplasty
 Procedure: Acromioplasty

Detailed Description:

There exists some controversy in the current trend in repair of full thickness tears of the rotator cuff. The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty. The purpose of acromioplasty is to create adequate space for the rotator cuff tendons. Arthroscopic acromioplasty involves the removal of the subacromial bursa, resection of the coracoacromial ligament and anteroinferior portion of the acromion, and resection of any osteophytes from the acromioclavicular joint that are thought to be contributing to impingement. However, acromioplasty without cuff repair has been reported to have both good and poor results, showing that the technique may be suspect in repair of full thickness tears alone.

The purpose of this study is to compare the effectiveness of arthroscopic cuff repair with acromioplasty to arthroscopic cuff repair without acromioplasty in repair of full thickness tears of the rotator cuff.

We hypothesize that there will be a significant clinical improvement in quality of life in patients who receive a rotator cuff repair without acromioplasty compared to those who receive a cuff repair with acromioplasty.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18 or older
  • Complete rotator cuff tear up to 4 cm in size
  • Persistent pain and functional disability for at least 6 months
  • Failure of conservative treatment
  • Establishment of final eligibility based upon visual exam of rotator cuff tear during surgery and determination of repairability

Exclusion Criteria:

  • Evidence of significant osteoarthritis or cartilage damage in the shoulder
  • Evidence of glenohumeral instability including Bankart lesions and labral tears of any type
  • Previous surgeries of the shoulder
  • Evidence of major joint trauma, infection, or necrosis in the shoulder
  • Patients with partial thickness tears of the rotator cuff
  • Patients unable to provide informed consent due to language barrier or mental status
  • Patients with a major medical condition that would affect quality of life and influence the results of the study
  • Patients with worker compensation claims
  • Patients unwilling to be followed for the duration of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290888

Locations
Canada, Manitoba
Panam Clinic
Winnipeg, Manitoba, Canada, R3M 3E4
Sponsors and Collaborators
Panam Clinic
Investigators
Principal Investigator: Peter MacDonald, MD, FRCS(C) Panam Clinic Orthopedics and Sports Medicine/University of Manitoba
  More Information

Publications:

Responsible Party: Peter MacDonald, Department Head, Orthopaedics, Panam Clinic
ClinicalTrials.gov Identifier: NCT00290888     History of Changes
Other Study ID Numbers: B2004:045
Study First Received: February 10, 2006
Last Updated: December 5, 2012
Health Authority: Canada: Health Canada

Keywords provided by Panam Clinic:
Rotator Cuff Tear
Tendon Repair
Acromioplasty
Arthroscopy
Orthopedic Surgery

Additional relevant MeSH terms:
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 19, 2013