Lower Trapezius Tendon Transfer vs Partial Cuff Repair in Massive Rotator Cuff Tears (NCT07051889) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Lower Trapezius Tendon Transfer vs Partial Cuff Repair in Massive Rotator Cuff Tears
Canada60 participantsStarted 2025-08-01
Plain-language summary
Very large tears of the shoulder tendons (the 'rotator cuff') that are not surgically repairable and in the absence of significant shoulder arthritis are common in older patients, and are associated with significant pain and functional limitations. Transfer of one particular tendon called the trapezius is becoming popular as a means of restoring function and improving pain in patients with massive rotator cuff tears. This tendon is appealing for transfer, as it has a similar line of pull to the infraspinatus (one of the rotator cuff tendons). There is currently no clear surgical consensus regarding the optimal treatment of patients with symptomatic massive irreparable rotator cuff tears that are appropriate candidates for joint salvage treatment, and no high level of evidence studies to guide clinical decision making have been published.
A pilot study is required prior to the development of a full-scale trial to assess its feasibility and recruitment across clinical sites, to determine protocol adherence (errors in randomization), and patient retention over a 12-month period.
The main objective of this pilot trial is to assess a composite measure of feasibility including recruitment, protocol adherence, and patient retention at one-year. The secondary objectives, currently exploratory only, are to determine the clinical outcomes of lower trapezius tendon transfer versus arthroscopic rotator cuff partial repair and biceps tenodesis/tenotomy on clinical outcome measures, shoulder function, adverse events and reoperation rates at two-years.
This pilot study is a parallel-group multicentre randomized controlled trial with participating sites across Canada, and one site in the United States.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult male and females over 18 years of age
* MRI confirmed diagnosis of massive rotator cuff tears defined using the Schumaier 2020 definition of massive cuff tears which includes the following criteria:
* Retraction of the tendons to the glenoid rim, measured in either the coronal or axial plane
* Greater than or equal to 67% of the greater tuberosity exposed in the axial plane
* Diagnosed either with MRI or intra-operatively \*\* Note: patients may be screened for inclusion using ultrasound, and the Cofield or Gerber definitions of massive cuff tear defined as either 5cm or greater in maximum length or 2 more tendon involvement respectively, however their must meet the Schumaier et al 2020 definition for final inclusion.
* Features of irreparability of their rotator cuff tendon tear including:
* Tendon retraction equal to or greater than 3cm16
* Remnant tendon length of supraspinatus \<15mm (as measured on coronal sequence of shoulder MRI)62
* Goutallier grade 3 or 4 fatty infiltration of the supraspinatus
* An external rotation lag present on clinical exam. A positive external rotation lag will be considered as inability to perform external rotation with or against gravity.
* Provision of informed consent
Exclusion Criteria:
* Patients with complete subscapularis tears
* Patients with concomitant injuries of the affected shoulder
* Previous surgery on the affected shoulder
* Hamada grade 3 or above changes on plain films of the shoul…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.