Full Thickness Rotator Cuff TearNCT01481480
Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears
A study testing Latissimus dorsi tendon transfer and Arthroscopic repair in people with Full Thickness Rotator Cuff Tear, run by Unity Health Toronto at 1 site in Canada.
Trial summary
A massive tear of the rotator cuff is a debilitating condition that causes pain, significant impairments in strength, and resultant loss of activity of the affected arm. To our knowledge, there is no Level 1 evidence comparing surgical procedures to treat massive rotator cuff tears. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Full Thickness Rotator Cuff Tear
- What is being tested?
- Latissimus dorsi tendon transfer and Arthroscopic repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to Dec 2021
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 40 to 65 years of age
- Massive rotator cuff tear, identified by MRI as being greater than 4cm in greatest diameter.
- Provision of informed consent
Who cannot join
- Absence of functioning latissimus dorsi muscle (assessed by "cough test"
- Absence of subscapularis muscle insertion (assessed by MRI)
- Glenohumeral arthritis of Grade 2 or higher, including evidence of acromio-humeral arthritis
- Acute tears (identifiable injury which precluded symptoms in past 6 months)
- Neurologic injury causing paralysis of affected shoulder girdle/arm
- Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery (ASA Grade IV or higher)
- Anticipated problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Western Hospital, St. Michael's Hospital, Holland Centre
Toronto, Ontario
About this study
Official title: A Multicenter, Randomized Controlled Trial Comparing Functional Outcomes After Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears
A massive tear of the rotator cuff is a debilitating condition that causes pain, significant impairments in strength, and resultant loss of activity of the affected arm. To our knowledge, there is no Level 1 evidence comparing surgical procedures to treat massive rotator cuff tears. Adding the first randomized controlled trial to will be a substantial contribution to the current body of evidence available in the subject of massive rotator cuff tears. Most studies found in the literature following patients with massive rotator cuff tears are retrospective, have small numbers of patients, offer no control group and do not adequately compare treatment methods.Moreover, there is no consensus from experts regarding which treatment is superior.
Our multicentre orthopaedic study group proposes a multicentre randomized clinical trial prospectively comparing latissimus dorsi tendon transfer to arthroscopic management for the treatment of massive rotator cuff tears. This study will include the use of comprehensive functional, motor and radiographic outcome assessments.
- Conditions
- Full Thickness Rotator Cuff Tear
- Being tested
- Latissimus dorsi tendon transfer, Arthroscopic repair
- Keywords
- shoulder, rotator cuff, tendon transfer, arthroscopic repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latissimus dorsi tendon transferProcedure or surgery
Latissimus dorsi tendon transfer
Arthroscopic repairProcedure or surgery
Arthroscopic repair
| Study group | Role | What they receive |
|---|---|---|
| Latissimus dorsi tendon transfer | Experimental | A Latissimus dorsi tendon transfer is performed Receives: Procedure: Latissimus dorsi tendon transfer |
| Arthroscopic repair | Active comparator | An arthroscopic repair is performed Receives: Procedure: Arthroscopic repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-Murley score
Constant-Murley score at 2 years
Measured: 2 years
Secondary outcomes (1)
Quick Dash
Quick Dash - limb specific patient outcome measurement
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startAug 2012
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full Thickness Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael McKee, MD, FRSC(C), Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481480
- Sponsor's protocol ID
- 16nov2011
- Status last verified
- Oct 2020
- First submitted
- 24 Nov 2011
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Trial Comparing Functional Outcomes After Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT01481480
- Acronym / sponsor ID
- 16nov2011
- Conditions
- Full Thickness Rotator Cuff Tear
- Keywords
- shoulder, rotator cuff, tendon transfer, arthroscopic repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, Sunnybrook Health Sciences Centre
- Study start
- Aug 2012
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 29 Nov 2011 (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.
A massive tear of the rotator cuff is a debilitating condition that causes pain, significant impairments in strength, and resultant loss of activity of the affected arm. To our knowledge, there is no Level 1 evidence comparing surgical procedures to treat massive rotator cuff tears. Adding the first randomized controlled trial to will be a substantial contribution to the current body of evidence available in the subject of massive rotator cuff tears. Most studies found in the literature following patients with massive rotator cuff tears are retrospective, have small numbers of patients, offer no control group and do not adequately compare treatment methods.Moreover, there is no consensus from experts regarding which treatment is superior.
Our multicentre orthopaedic study group proposes a multicentre randomized clinical trial prospectively comparing latissimus dorsi tendon transfer to arthroscopic management for the treatment of massive rotator cuff tears. This study will include the use of comprehensive functional, motor and radiographic outcome assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Latissimus dorsi tendon transfer | Experimental | Procedure: Latissimus dorsi tendon transferA Latissimus dorsi tendon transfer is performed |
| Arthroscopic repair | Active comparator | Procedure: Arthroscopic repairAn arthroscopic repair is performed |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women aged 40 to 65 years of age
- Massive rotator cuff tear, identified by MRI as being greater than 4cm in greatest diameter.
- Provision of informed consent
Key exclusion criteria (7 listed)
- Absence of functioning latissimus dorsi muscle (assessed by "cough test"
- Absence of subscapularis muscle insertion (assessed by MRI)
- Glenohumeral arthritis of Grade 2 or higher, including evidence of acromio-humeral arthritis
- Acute tears (identifiable injury which precluded symptoms in past 6 months)
- Neurologic injury causing paralysis of affected shoulder girdle/arm
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 |
|---|---|---|
| Latissimus dorsi tendon transferLatissimus dorsi tendon transfer | Procedure or surgery | Latissimus dorsi tendon transfer |
| Arthroscopic repairArthroscopic repair | Procedure or surgery | Arthroscopic repair |
Primary outcome
Constant-Murley score
Time frame: 2 years
Constant-Murley score at 2 years
1 secondary outcome
Quick Dash
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
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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.
Michael McKee, MD, FRSC(C) principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latissimus dorsi tendon transfer and Arthroscopic repair in people with Full Thickness Rotator Cuff Tear, run by Unity Health Toronto 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Oct 2020. 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?
Results are not available in the source record.
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?
Constant-Murley score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2020.