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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00290888
First Posted: February 13, 2006
Last Update Posted: March 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter MacDonald, Panam Clinic
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Peter MacDonald, Panam Clinic:

Primary Outcome Measures:
  • Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 24 months ]
    Calculated as percentage with an increase in score indicating an improvement in outcome.

  • American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES) [ Time Frame: 24 months ]
    Calculated as a percentage with an increase in score reflecting an improvement in outcome.


Secondary Outcome Measures:
  • Shoulder Range of Motion [ Time Frame: 24 months ]
  • Upper Extremity Strength Grading [ Time Frame: 24 months ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: February 10, 2006
First Posted: February 13, 2006
Results First Submitted: March 5, 2014
Results First Posted: May 9, 2014
Last Update Posted: March 27, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Rotator Cuff Injuries
Shoulder Impingement Syndrome
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases