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

P

Panam Clinic

Status

Completed

Conditions

Rotator Cuff Tear
Shoulder Impingement Syndrome

Treatments

Procedure: Acromioplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT00290888
B2004:045

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

86 participants in 2 patient groups

ACR
Active Comparator group
Description:
Arthroscopic rotator cuff repair without acromioplasty
Treatment:
Procedure: Acromioplasty
ACR-A
Experimental group
Description:
Arthorscopic rotator cuff repair with acromioplasty
Treatment:
Procedure: Acromioplasty

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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