Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00664794 |
| Other study ID # |
2005883-01H |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2006 |
| Est. completion date |
April 2011 |
Study information
| Verified date |
May 2021 |
| Source |
Ottawa Hospital Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 execution of the
traditional arthroscopic cuff repair without acromioplasty.
Description:
The rotator cuff is a musculotendinous amalgamation of four muscles that arise from the
scapula and insert on the proximal humerus. The tendons of the supraspinatus, infraspinatus,
subscapularis, and teres minor form a continuous cuff around the humeral head and allow for a
variety of movements in rotation of the humeral head. Tears of one or more of these tendons
that comprise the rotator cuff are one of the many causes of pain and disability in the
shoulder12. Treatment of these tears has included both operative and non-operative
approaches. The non-operative approaches have generally included modification of activities,
administration of analgesic or anti-inflammatory medication, and a progressive physiotherapy
program aimed at regaining a full range of motion about the shoulder and full strength in the
rotator cuff. The results stemming from this treatment have for the most part been
disappointing 13.
Codman16 was the first to describe an open surgical technique for rotator cuff repair and
Neer17 later refined the existing surgical technique in addition to being the first to apply
acromioplasty to repair of tears of the rotator cuff. Since that time, operative repair of
full-thickness tears of the rotator cuff has gradually shifted from open repair to
arthroscopic repair with some combined open/arthroscopic (mini-open) procedures being
performed. The mini-open procedure involves arthroscopic evaluation of the glenohumeral joint
and arthroscopic acromioplasty coupled with open repair of the cuff tear15. As surgeons
gained experience with the mini-open repair, they began to familiarize themselves with the
arthroscopic appearance of rotator cuff tears and improved their ability to arthroscopically
measure the tear and assess its repairability4. These advances combined with improvements in
arthroscopic instruments and suturing techniques have allowed the elimination of the open
portion of the mini-open repair and the emergence of a completely arthroscopic procedure.
Exclusive arthroscopic repair of rotator cuff tears provides the advantages of deltoid
preservation, less soft tissue dissection, shortened hospital stay, and accelerated
rehabilitation. It also allows for visualization of the glenohumeral joint, which can be
advantageous since several authors have reported a 60-75 % incidence of coinciding
glenohumeral pathologies with cuff tears5,6.
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 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 good9,10 and poor11,14 results, showing that the technique may be
suspect in repair of full-thickness tears alone.
Budoff and his colleagues have suggested that since the coracoacromial ligament stabilizes
the rotator cuff to prevent uncontrolled migration of the humeral head, resection of the
coracoacromial ligament during arthroscopic acromioplasty may cause additional long-term
migration of the humeral head7. Likewise, Nirschl has suggested that the coracoacromial
ligament be resected only in those cases with a specific pathological indication relating to
the coracoacromial ligament8. He also states that, "there is no evidence to support the
belief that failure to resect the coracoacromial ligament compromises the success of rotator
cuff surgery."
