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Shoulder InjuriesNCT00664794

Rotator Cuff Repair With Arthroscopic Acromioplasty (Shaving the Acromion Bone) Versus Repair Without Acromioplasty

A study testing without acromioplasty and with acromioplasty in people with Shoulder Injuries, run by Ottawa Hospital Research Institute at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shoulder Injuries
What is being tested?
without acromioplasty and with acromioplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesCanada
Study dates
Oct 2006to Apr 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older
  • Diagnosis of full-thickness rotator cuff tear
  • Ability to understand and adhere to rehab protocols and testing procedure
  • Persistent pain and functional disability for at least 6 months and failure of 6 months of conservative treatment

Who cannot join

  • 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
Show all 10Show fewer
  • 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.
  • Patient is automatically ineligible for study if 1 or more exclusion criteria is present.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • The Ottawa Hospital

    Ottawa, Ontario, K1Y 4E9

  • Pan Am Clinic Foundation

    Winnipeg, Manitoba, R3M 3E4

Other trials in Canada

About this study

Official title: Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff Tears

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.

Read the detailed 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."

Being tested
without acromioplasty, with acromioplasty
Medical subject headings
Shoulder Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • without acromioplastyProcedure or surgery

    This group will not have their acromion shaved - instead they will receive a repair of their rotator cuff with the scope using sutures or suture anchors.

  • with acromioplastyProcedure or surgery

    This group will have Their rotator cuff repaired with sutures or suture anchors and additionally will have the tip of their acromion bone shaved slightly.

Study groups in NCT00664794
Study groupRoleWhat they receive
without acromioplastyActive comparatorNot described
Receives: Procedure: without acromioplasty
with acromioplastyActive comparatorNot described
Receives: Procedure: with acromioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine clinical impact by comparing the intervention and control sites for:

    Measured: Feb 2008

  2. Patient satisfaction

    Measured: end of study

Secondary outcomes (2)
  1. Determine sustainability of the impact;

    Measured: end of study

  2. Accuracy

    Measured: end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2008 (estimated)
  2. Study startOct 2006
  3. Primary completionApr 2011
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00664794
Sponsor's protocol ID
2005883-01H
Status last verified
May 2021
First submitted
21 Jan 2008
Last updated
17 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • MacDonald P, McRae S, Leiter J, Mascarenhas R, Lapner P. Arthroscopic rotator cuff repair with and without acromioplasty in the treatment of full-thickness rotator cuff tears: a multicenter, randomized controlled trial. J Bone Joint Surg Am. 2011 Nov 2;93(21):1953-60. doi: 10.2106/JBJS.K.00488.

    PubMed 22048089

Questions about this trial

What is this clinical trial studying?

A study testing without acromioplasty and with acromioplasty in people with Shoulder Injuries, run by Ottawa Hospital Research Institute at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine clinical impact by comparing the intervention and control sites for: (time frame: Feb 2008). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00664794, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.

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