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.
Adult male and females over 18 years of age
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.
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 shoulder
Ottawa Hospital Research Institute
Lead sponsor
Canadian Orthopaedic Foundation
Collaborator