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.
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
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."
- Conditions
- Shoulder Injuries
- 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 group | Role | What they receive |
|---|---|---|
| without acromioplasty | Active comparator | Not described Receives: Procedure: without acromioplasty |
| with acromioplasty | Active comparator | Not described Receives: Procedure: with acromioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine clinical impact by comparing the intervention and control sites for:
Measured: Feb 2008
Patient satisfaction
Measured: end of study
Secondary outcomes (2)
Determine sustainability of the impact;
Measured: end of study
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.
- First posted23 Apr 2008 (estimated)
- Study startOct 2006
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder InjuriesStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Lapner, MD, Study chair, Ottawa Hospital Research Institute
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
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT00664794
- Acronym / sponsor ID
- 2005883-01H
- Conditions
- Shoulder Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Oct 2006 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| without acromioplasty | Active comparator | Procedure: without acromioplasty |
| with acromioplasty | Active comparator | Procedure: with acromioplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| without acromioplastyThis 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. | Procedure or surgery | without acromioplasty |
| with acromioplastyThis group will have Their rotator cuff repaired with sutures or suture anchors and additionally will have the tip of their acromion bone shaved slightly. | Procedure or surgery | with acromioplasty |
Primary outcome
Determine clinical impact by comparing the intervention and control sites for:
Time frame: Feb 2008
Patient satisfaction
Time frame: end of study
2 secondary outcomes
Determine sustainability of the impact;
Time frame: end of study
Accuracy
Time frame: end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Results publication: PubMed 22048089MacDonald 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Lapner, MD study chair
Ottawa Hospital Research Institute
2 sites in 1 country: see every site and its status.
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.