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

NCT ID: NCT00290888

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2011-03-31

Brief Summary

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.

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.

Conditions

Rotator Cuff Tear; Shoulder Impingement Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACR

Arthroscopic rotator cuff repair without acromioplasty

Group Type: ACTIVE_COMPARATOR

Acromioplasty

Intervention Type: PROCEDURE

ACR-A

Arthorscopic rotator cuff repair with acromioplasty

Group Type: EXPERIMENTAL

Acromioplasty

Intervention Type: PROCEDURE

Interventions

Acromioplasty

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Panam Clinic

OTHER

Sponsor Role: lead

Responsible Party

Peter MacDonald

Department Head, Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter MacDonald, MD, FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Panam Clinic Orthopedics and Sports Medicine/University of Manitoba

Locations

Panam Clinic

Winnipeg, Manitoba, Canada

Countries

Canada

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

B2004:045

Identifier Type: -

Identifier Source: org_study_id