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

February 10, 2006
December 5, 2012
April 2004
March 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Western Ontario Rotator Cuff Index (WORC)
  • American Shoulder and Elbow Surgeons standardized form for the assessment of the shoulder (ASES)
  • Time of both measures: pre-op (1 month); post-op at 6 weeks, 3, 6, 12, 18, and 24 months
Complete list of historical versions of study NCT00290888 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Shoulder range of motion
  • Upper extremity strength grading
  • Time of measures: pre-op (1 month); post-op at 6 weeks, 3, 6, 12, 18, and 24 months
Not Provided
Not Provided
 
Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty
Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Rotator Cuff Tear
  • Shoulder Impingement Syndrome
Procedure: Acromioplasty
  • Active Comparator: ACR
    Arthroscopic rotator cuff repair without acromioplasty
    Intervention: Procedure: Acromioplasty
  • Experimental: ACR-A
    Arthorscopic rotator cuff repair with acromioplasty
    Intervention: Procedure: Acromioplasty

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00290888
B2004:045
No
Peter MacDonald, Panam Clinic
Panam Clinic
Not Provided
Principal Investigator: Peter MacDonald, MD, FRCS(C) Panam Clinic Orthopedics and Sports Medicine/University of Manitoba
Panam Clinic
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP