Clinical trial NCT00290888: Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty
Official title: Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Shoulder Impingement Syndrome
Keywords: Rotator Cuff Tear
Tendon Repair
Acromioplasty
Arthroscopy
Orthopedic Surgery
Lead sponsor: Panam Clinic
Sponsor class: OTHER
First posted: 2006-02-13
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: 24 months
measure: American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)
timeFrame: 24 months
Secondary outcomes:
measure: Shoulder Range of Motion
timeFrame: 24 months
measure: Upper Extremity Strength Grading
timeFrame: 24 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Panam Clinic
state: Manitoba
Study officials:
affiliation: Panam Clinic Orthopedics and Sports Medicine/University of Manitoba
name: Peter MacDonald, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
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