Shoulder PainPhase 3NCT00128076
All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears
A Phase 3 study testing All-Arthroscopic repair and Mini-open repair in people with Shoulder Pain and Rotator Cuff Tear, run by McMaster University at 9 sites in Canada.
Trial summary
This study will compare two different surgical techniques for repairing a tear in the muscles of the shoulder (rotator cuff). The investigators will determine whether an arthroscopic or mini-open technique provides better quality of life and repair integrity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Pain, Rotator Cuff Tear
- What is being tested?
- All-Arthroscopic repair and Mini-open repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 9 sitesCanada
- Study dates
- Aug 2006to Dec 2015
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The investigators will recruit patients with small or medium rotator cuff tears as determined by clinical examination and diagnostic imaging (magnetic resonance imaging [MRI]) prior to surgery.
- The full-thickness rotator cuff tears of supraspinatus and infraspinatus will be classified into 2 categories based on area of longest dimension.
- SMALL= 0-1 cm;
- MODERATE =1-3 cm.
- Definitive measurement of tear size will be made in surgery and used as a covariate in analysis. (JOINTS measurement protocol will be used)
Who cannot join
- Pre-Operative Exclusion Criteria
- Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder or previous surgery of the affected shoulder,
- Evidence of significant cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations,
- Major medical illness (life expectancy less then 2 years or unacceptably high operative risk),
- Unable to speak or read English,
- Psychiatric illness that precludes informed consent,
Show all 12Show fewer
- Unwilling to be followed for 2 years.
- Intra-Operative Exclusion Criteria
- Large, massive or irreparable cuff tears, extending into the subscapularis or teres minor, which cannot be mobilized to the articular margin or repaired using one or both of the techniques (all arthroscopic or mini-open),
- Teres minor or subscapularis tears,
- Inelastic and immobile tendon, which cannot be advanced to articular margin,
- Co-existing labral pathologies requiring repair with sutures (superior labral anterior posterior [SLAP] II-IV), Bankart lesions requiring repair, partial tears of biceps (more than 60% of thickness) requiring tenodesis or release.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
University of Calgary Sport Medicine Centre
Calgary, Alberta, T2N 1N4
Walter Mackenzie Centre
Edmonton, Alberta, T6B 2G7
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Kingston General Hospital
Kingston, Ontario
Fowler Kennedy Sports Medicine Clinic
London, Ontario, N6A 3K7
St. Joseph's Health Care London
London, Ontario, N6A 4V2
Royal Columbian Hospital
New Westminster, British Columbia, V3S 3W7
Orthopaedic and Arthritic Hospital
Toronto, Ontario
PanAm Clinic
Winnipeg, Manitoba, R3M 3E4
About this study
This study will compare two different surgical techniques for repairing a tear in the muscles of the shoulder (rotator cuff). The investigators will determine whether an arthroscopic or mini-open technique provides better quality of life and repair integrity.
Read the detailed description
Background:
Rotator cuff tears are the most common source of shoulder pain and disability. Only poor quality studies have compared mini-open to arthroscopic repair, leaving surgeons with inadequate evidence to support optimal, minimally-invasive repair.
Methods/Design:
This randomized, multi-centre, national trial will determine whether an arthroscopic or mini-open repair provides better quality of life for patients with small or moderate sized rotator cuff tears. A national consensus meeting of investigators in Joints Orthopaedic Initiative for Shoulder Trials (JOINTS) identified this question as the top priority for shoulder surgeons across Canada. The primary outcome measure is a valid quality-of-life scale (Western Ontario Rotator Cuff (WORC) that addresses 5 domains of health affected by rotator cuff disease. Secondary outcomes will assess rotator cuff functionality (ROM, strength, constant score), secondary dimensions of health (general health status (SF-12) and work limitations) and repair integrity (MRI). Outcomes are measured at baseline, at 6 weeks, 3, 6, 12 and 24 months postoperatively by blinded research assistants and musculoskeletal radiologists. Patients (n=250) with small or medium-sized cuff tears identified by clinical examination and MRI who meet eligibility criteria will be recruited. This sample size will provide 80% power to detect (statistically) a clinically important difference of 20% in WORC scores between procedures after controlling for baseline WORC score ("=0.05). A central methods centre will manage randomization, data management and monitoring under supervision of experienced epidemiologists. Surgeons will participate in either conventional or expertise-based designs according to defined criteria, to avoid biases from differential surgeon expertise. Mini-open or all-arthroscopic repair procedures, will be performed according to a standardized protocol. Central Adjudication (of cases), Trial Oversight and Safety Committees will monitor trial conduct. The investigators will use an analysis of covariance (ANCOVA), where the baseline WORC score is used as a covariate, to compare the quality of life (WORC score) at 2-years post-operatively. As a secondary analysis the investigators will conduct the same statistical test but will include age and tear size as covariates with the baseline score. Enrollment will require 2 years and follow-up an additional 2-years.
- Conditions
- Shoulder Pain, Rotator Cuff Tear
- Being tested
- All-Arthroscopic repair, Mini-open repair
- Keywords
- shoulder surgery, rotator cuff, arthroscopic repair, mini-open repair
- Medical subject headings
- Shoulder Pain, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All-Arthroscopic repairProcedure or surgery
joint techniques and repair are both performed entirely through the arthroscope
Mini-open repairProcedure or surgery
repair is performed though a small incision and the arthroscope can be used to address problems within the joint (as per traditional diagnostic procedures)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | All-arthroscopic repair Receives: Procedure: All-Arthroscopic repair |
| 2 | Active comparator | Mini-open repair Receives: Procedure: Mini-open repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measure specific to rotator cuff disease (Western Ontario Rotator Cuff Questionnaire (WORC)
Measured: within 2 years
Secondary outcomes (7)
SF-12
Measured: within 2 years
Work Limitations Scale
Measured: within 2 years
Cuff integrity on imaging
Measured: within 1 year post-operative
Strength
Measured: within 2 years
Range of Motion
Measured: within 2 years
American Shoulder and Elbow Surgeons (ASES) shoulder scale
Measured: within 2 years
Shoulder and Pain Disability Index (SPADI)
Measured: Within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startAug 2006
- Primary completionAug 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Joy MacDermid, McMaster University
- Investigators
- Joy C MacDermid, PhD, Principal investigator, McMaster University, University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128076
- Sponsor's protocol ID
- MCT-82335
- Status last verified
- May 2016
- First submitted
- 5 Aug 2005
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
MacDermid JC, Holtby R, Razmjou H, Bryant D; JOINTS Canada. All-arthroscopic versus mini-open repair of small or moderate-sized rotator cuff tears: a protocol for a randomized trial [NCT00128076]. BMC Musculoskelet Disord. 2006 Mar 10;7:25. doi: 10.1186/1471-2474-7-25.
PubMed 16529658MacDermid JC, Bryant D, Holtby R, Razmjou H, Faber K; JOINTS Canada; Balyk R, Boorman R, Sheps D, McCormack R, Athwal G, Hollinshead R, Lo I, Bicknell R, Mohtadi N, Bouliane M, Glasgow D, Lebel ME, Lalani A, Moola FO, Litchfield R, Moro J, MacDonald P, Bergman JW, Bury J, Drosdowech D. Arthroscopic Versus Mini-open Rotator Cuff Repair: A Randomized Trial and Meta-analysis. Am J Sports Med. 2021 Oct;49(12):3184-3195. doi: 10.1177/03635465211038233. Epub 2021 Sep 15.
PubMed 34524031
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT00128076
- Acronym / sponsor ID
- MCT-82335
- Conditions
- Shoulder Pain, Rotator Cuff Tear
- Keywords
- shoulder surgery, rotator cuff, arthroscopic repair, mini-open repair
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation
- Study start
- Aug 2006
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Aug 2005 (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.
This study will compare two different surgical techniques for repairing a tear in the muscles of the shoulder (rotator cuff). The investigators will determine whether an arthroscopic or mini-open technique provides better quality of life and repair integrity.
Detailed description
Background:
Rotator cuff tears are the most common source of shoulder pain and disability. Only poor quality studies have compared mini-open to arthroscopic repair, leaving surgeons with inadequate evidence to support optimal, minimally-invasive repair.
Methods/Design:
This randomized, multi-centre, national trial will determine whether an arthroscopic or mini-open repair provides better quality of life for patients with small or moderate sized rotator cuff tears. A national consensus meeting of investigators in Joints Orthopaedic Initiative for Shoulder Trials (JOINTS) identified this question as the top priority for shoulder surgeons across Canada. The primary outcome measure is a valid quality-of-life scale (Western Ontario Rotator Cuff (WORC) that addresses 5 domains of health affected by rotator cuff disease. Secondary outcomes will assess rotator cuff functionality (ROM, strength, constant score), secondary dimensions of health (general health status (SF-12) and work limitations) and repair integrity (MRI). Outcomes are measured at baseline, at 6 weeks, 3, 6, 12 and 24 months postoperatively by blinded research assistants and musculoskeletal radiologists. Patients (n=250) with small or medium-sized cuff tears identified by clinical examination and MRI who meet eligibility criteria will be recruited. This sample size will provide 80% power to detect (statistically) a clinically important difference of 20% in WORC scores between procedures after controlling for baseline WORC score ("=0.05). A central methods centre will manage randomization, data management and monitoring under supervision of experienced epidemiologists. Surgeons will participate in either conventional or expertise-based designs according to defined criteria, to avoid biases from differential surgeon expertise. Mini-open or all-arthroscopic repair procedures, will be performed according to a standardized protocol. Central Adjudication (of cases), Trial Oversight and Safety Committees will monitor trial conduct. The investigators will use an analysis of covariance (ANCOVA), where the baseline WORC score is used as a covariate, to compare the quality of life (WORC score) at 2-years post-operatively. As a secondary analysis the investigators will conduct the same statistical test but will include age and tear size as covariates with the baseline score. Enrollment will require 2 years and follow-up an additional 2-years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: All-Arthroscopic repairAll-arthroscopic repair |
| 2 | Active comparator | Procedure: Mini-open repairMini-open repair |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The investigators will recruit patients with small or medium rotator cuff tears as determined by clinical examination and diagnostic imaging (magnetic resonance imaging [MRI]) prior to surgery.
- The full-thickness rotator cuff tears of supraspinatus and infraspinatus will be classified into 2 categories based on area of longest dimension.
- Definitive measurement of tear size will be made in surgery and used as a covariate in analysis. (JOINTS measurement protocol will be used)
Key exclusion criteria (12 listed)
- Pre-Operative Exclusion Criteria
- Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder or previous surgery of the affected shoulder,
- Evidence of significant cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations,
- Major medical illness (life expectancy less then 2 years or unacceptably high operative risk),
- Unable to speak or read English,
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 |
|---|---|---|
| All-Arthroscopic repairjoint techniques and repair are both performed entirely through the arthroscope | Procedure or surgery | 1 |
| Mini-open repairrepair is performed though a small incision and the arthroscope can be used to address problems within the joint (as per traditional diagnostic procedures) | Procedure or surgery | 2 |
Primary outcome
Quality of life measure specific to rotator cuff disease (Western Ontario Rotator Cuff Questionnaire (WORC)
Time frame: within 2 years
7 secondary outcomes
SF-12
Time frame: within 2 years
Work Limitations Scale
Time frame: within 2 years
Cuff integrity on imaging
Time frame: within 1 year post-operative
Strength
Time frame: within 2 years
Range of Motion
Time frame: within 2 years
American Shoulder and Elbow Surgeons (ASES) shoulder scale
Time frame: within 2 years
Shoulder and Pain Disability Index (SPADI)
Time frame: Within 2 years
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 27 May 2016.
- Background: PubMed 16529658MacDermid JC, Holtby R, Razmjou H, Bryant D; JOINTS Canada. All-arthroscopic versus mini-open repair of small or moderate-sized rotator cuff tears: a protocol for a randomized trial [NCT00128076]. BMC Musculoskelet Disord. 2006 Mar 10;7:25. doi: 10.1186/1471-2474-7-25.
- Derived from this study: PubMed 34524031MacDermid JC, Bryant D, Holtby R, Razmjou H, Faber K; JOINTS Canada; Balyk R, Boorman R, Sheps D, McCormack R, Athwal G, Hollinshead R, Lo I, Bicknell R, Mohtadi N, Bouliane M, Glasgow D, Lebel ME, Lalani A, Moola FO, Litchfield R, Moro J, MacDonald P, Bergman JW, Bury J, Drosdowech D. Arthroscopic Versus Mini-open Rotator Cuff Repair: A Randomized Trial and Meta-analysis. Am J Sports Med. 2021 Oct;49(12):3184-3195. doi: 10.1177/03635465211038233. Epub 2021 Sep 15.
Related trials for Shoulder Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
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.
Joy C MacDermid, PhD principal investigator
McMaster University, University of Western Ontario
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing All-Arthroscopic repair and Mini-open repair in people with Shoulder Pain and Rotator Cuff Tear, run by McMaster University at 9 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 5 inclusion and 12 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 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of life measure specific to rotator cuff disease (Western Ontario Rotator Cuff Questionnaire (WORC) (time frame: within 2 years). 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 NCT00128076, which also lists 2 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 May 2016.