Lower Trapezius Tendon Transfer vs Partial Cuff Repair in Massive Rotator Cuff Tears

N/ANot Yet RecruitingNCT07051889

Ottawa Hospital Research Institute60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Interventions

Lower Trapezius Tendon TransferPROCEDURE

This procedure is performed arthroscopically. The lower trapezius tendon is harvested from the back of the shoulder blade. A donor tendon is then used to extend the lower trapezius tendon so that it can reach the top of the arm bone. The tendon graft is then attached to the top of the arm bone, while the other end remains attached to the lower trapezius tendon itself. Any additional concomitant procedures (e.g. debridement, biceps release…etc.) may be performed as well.

Partial Rotator Cuff RepairPROCEDURE

This procedure is performed arthroscopically. The massive rotator cuff tear will be repaired by securing the loose tendon ends to the bone with suture anchors. The surgeon may also conduct a debridement of the area to remove any broken-down cartilage and tissues. Finally, the biceps tendon in will be further inspected for any damage or inflammatory changes, and the tendon may be released at the discretion of the surgeon (known as a biceps tenodesis or tenotomy depending on technique).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 shoulder * Substantial shoulder comorbidity (e.g. Bankart lesion or osteoarthritis \[defined as joint space narrowing or osteophytes present on radiographs and confirmed at the time of arthroscopy\]) * Substantial medical comorbidity that could impact the effectiveness of surgical intervention * Inability to speak English or French * Patients that will likely have difficulty with maintaining follow-up in the opinion of the evaluators (no fixed address, unwilling to be followed, incarcerated individuals, etc.) * Cases involving litigation or workplace insurance claims

Outcomes

Primary Outcomes

Feasibility of Recruitment and Follow-Up

Assess the feasibility of this pilot trial as determined by: (1) Recruitment rate of 6 per month across study centres; (2) 3 or fewer crossovers for enrolled participants; and (3) 85% of participants have a full adherence to protocol.

Time frame: 1-year

Secondary Outcomes

The Western Ontario Rotator Cuff Score (WORC)

The WORC is a disease specific evaluation, proven to be an accurate and valid assessment of quality of life for rotator cuff disease. The WORC is a patient-reported measure, 21-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean a worse outcome.