Rotator Cuff TearNCT00290888
Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty
A study testing Acromioplasty in people with Rotator Cuff Tear and Shoulder Impingement Syndrome, run by Panam Clinic at 1 site 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
- Rotator Cuff Tear, Shoulder Impingement Syndrome
- What is being tested?
- Acromioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2004to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
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 9Show 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff
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.
Read the 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.
- Conditions
- Rotator Cuff Tear, Shoulder Impingement Syndrome
- Being tested
- Acromioplasty
- Keywords
- Rotator Cuff Tear, Tendon Repair, Acromioplasty, Arthroscopy, Orthopedic Surgery
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcromioplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ACR | Active comparator | Arthroscopic rotator cuff repair without acromioplasty Receives: Procedure: Acromioplasty |
| ACR-A | Experimental | Arthorscopic rotator cuff repair with acromioplasty Receives: Procedure: Acromioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Rotator Cuff Index (WORC)
Calculated as percentage with an increase in score indicating an improvement in outcome.
Measured: 24 months
American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)
Calculated as a percentage with an increase in score reflecting an improvement in outcome.
Measured: 24 months
Secondary outcomes (2)
Shoulder Range of Motion
Measured: 24 months
Upper Extremity Strength Grading
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startApr 2004
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panam Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter MacDonald, Panam Clinic
- Investigators
- Peter MacDonald, MD, FRCS(C), Principal investigator, Panam Clinic Orthopedics and Sports Medicine/University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290888
- Sponsor's protocol ID
- B2004:045
- Status last verified
- Mar 2015
- First submitted
- 10 Feb 2006
- Last updated
- 27 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kirkley A, Griffin S, McLintock H, Ng L. The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability. The Western Ontario Shoulder Instability Index (WOSI). Am J Sports Med. 1998 Nov-Dec;26(6):764-72. doi: 10.1177/03635465980260060501.
PubMed 9850776Baker CL, Liu SH. Comparison of open and arthroscopically assisted rotator cuff repairs. Am J Sports Med. 1995 Jan-Feb;23(1):99-104. doi: 10.1177/036354659502300117.
PubMed 7726359Gartsman GM. Arthroscopic assessment of rotator cuff tear reparability. Arthroscopy. 1996 Oct;12(5):546-9. doi: 10.1016/s0749-8063(96)90192-9.
PubMed 8902127Miller C, Savoie FH. Glenohumeral abnormalities associated with full-thickness tears of the rotator cuff. Orthop Rev. 1994 Feb;23(2):159-62.
PubMed 8196974Budoff JE, Nirschl RP, Guidi EJ. Debridement of partial-thickness tears of the rotator cuff without acromioplasty. Long-term follow-up and review of the literature. J Bone Joint Surg Am. 1998 May;80(5):733-48. doi: 10.2106/00004623-199805000-00016. No abstract available.
PubMed 9611036Gartsman GM, Taverna E. The incidence of glenohumeral joint abnormalities associated with full-thickness, reparable rotator cuff tears. Arthroscopy. 1997 Aug;13(4):450-5. doi: 10.1016/s0749-8063(97)90123-7.
PubMed 9276051Esch JC. Arthroscopic subacromial decompression and postoperative management. Orthop Clin North Am. 1993 Jan;24(1):161-71.
PubMed 8421609Levy HJ, Gardner RD, Lemak LJ. Arthroscopic subacromial decompression in the treatment of full-thickness rotator cuff tears. Arthroscopy. 1991;7(1):8-13. doi: 10.1016/0749-8063(91)90071-5.
PubMed 2009126Cofield RH. Rotator cuff disease of the shoulder. J Bone Joint Surg Am. 1985 Jul;67(6):974-9. No abstract available.
PubMed 4019548Bokor DJ, Hawkins RJ, Huckell GH, Angelo RL, Schickendantz MS. Results of nonoperative management of full-thickness tears of the rotator cuff. Clin Orthop Relat Res. 1993 Sep;(294):103-10.
PubMed 8358901Ellman H, Kay SP, Wirth M. Arthroscopic treatment of full-thickness rotator cuff tears: 2- to 7-year follow-up study. Arthroscopy. 1993;9(2):195-200. doi: 10.1016/s0749-8063(05)80374-3.
PubMed 8461081Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am. 1972 Jan;54(1):41-50. No abstract available.
PubMed 5054450
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. 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
- ClinicalTrials.gov ID
- NCT00290888
- Acronym / sponsor ID
- B2004:045
- Conditions
- Rotator Cuff Tear, Shoulder Impingement Syndrome
- Keywords
- Rotator Cuff Tear, Tendon Repair, Acromioplasty, Arthroscopy, Orthopedic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Panam ClinicUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 Feb 2006 (estimated)
- Results
- Posted 9 May 2014
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACR | Active comparator | Procedure: AcromioplastyArthroscopic rotator cuff repair without acromioplasty |
| ACR-A | Experimental | Procedure: AcromioplastyArthorscopic rotator cuff repair with acromioplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 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 |
|---|---|---|
| Acromioplasty | Procedure or surgery | ACR, ACR-A |
Primary outcome
Western Ontario Rotator Cuff Index (WORC)
Time frame: 24 months
Calculated as percentage with an increase in score indicating an improvement in outcome.
American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)
Time frame: 24 months
Calculated as a percentage with an increase in score reflecting an improvement in outcome.
2 secondary outcomes
Shoulder Range of Motion
Time frame: 24 months
Upper Extremity Strength Grading
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9850776Kirkley A, Griffin S, McLintock H, Ng L. The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability. The Western Ontario Shoulder Instability Index (WOSI). Am J Sports Med. 1998 Nov-Dec;26(6):764-72. doi: 10.1177/03635465980260060501.
- Background: PubMed 7726359Baker CL, Liu SH. Comparison of open and arthroscopically assisted rotator cuff repairs. Am J Sports Med. 1995 Jan-Feb;23(1):99-104. doi: 10.1177/036354659502300117.
- Background: PubMed 8902127Gartsman GM. Arthroscopic assessment of rotator cuff tear reparability. Arthroscopy. 1996 Oct;12(5):546-9. doi: 10.1016/s0749-8063(96)90192-9.
- Background: PubMed 8196974Miller C, Savoie FH. Glenohumeral abnormalities associated with full-thickness tears of the rotator cuff. Orthop Rev. 1994 Feb;23(2):159-62.
- Background: PubMed 9611036Budoff JE, Nirschl RP, Guidi EJ. Debridement of partial-thickness tears of the rotator cuff without acromioplasty. Long-term follow-up and review of the literature. J Bone Joint Surg Am. 1998 May;80(5):733-48. doi: 10.2106/00004623-199805000-00016. No abstract available.
- Background: PubMed 9276051Gartsman GM, Taverna E. The incidence of glenohumeral joint abnormalities associated with full-thickness, reparable rotator cuff tears. Arthroscopy. 1997 Aug;13(4):450-5. doi: 10.1016/s0749-8063(97)90123-7.
- Background: PubMed 8421609Esch JC. Arthroscopic subacromial decompression and postoperative management. Orthop Clin North Am. 1993 Jan;24(1):161-71.
- Background: PubMed 2009126Levy HJ, Gardner RD, Lemak LJ. Arthroscopic subacromial decompression in the treatment of full-thickness rotator cuff tears. Arthroscopy. 1991;7(1):8-13. doi: 10.1016/0749-8063(91)90071-5.
- Background: PubMed 4019548Cofield RH. Rotator cuff disease of the shoulder. J Bone Joint Surg Am. 1985 Jul;67(6):974-9. No abstract available.
- Background: PubMed 8358901Bokor DJ, Hawkins RJ, Huckell GH, Angelo RL, Schickendantz MS. Results of nonoperative management of full-thickness tears of the rotator cuff. Clin Orthop Relat Res. 1993 Sep;(294):103-10.
- Background: PubMed 8461081Ellman H, Kay SP, Wirth M. Arthroscopic treatment of full-thickness rotator cuff tears: 2- to 7-year follow-up study. Arthroscopy. 1993;9(2):195-200. doi: 10.1016/s0749-8063(05)80374-3.
- Background: PubMed 5054450Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am. 1972 Jan;54(1):41-50. No abstract available.
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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 MacDonald, MD, FRCS(C) principal investigator
Panam Clinic Orthopedics and Sports Medicine/University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acromioplasty in people with Rotator Cuff Tear and Shoulder Impingement Syndrome, run by Panam Clinic at 1 site 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 5 inclusion and 9 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 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 9 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Western Ontario Rotator Cuff Index (WORC) (time frame: 24 months). 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 NCT00290888, which also lists 12 linked publications.
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 27 Mar 2015.