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

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.

Conditions

• Massive Rotator Cuff Tear

Interventions

PROCEDURE

Lower Trapezius Tendon Transfer

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.

PROCEDURE

Partial Rotator Cuff Repair

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).

Sponsors & Collaborators

• Canadian Orthopaedic Foundation

  collaborator OTHER

• Ottawa Hospital Research Institute

  lead OTHER

Principal Investigators

• Peter Lapner, MD FRCSC · The Ottawa Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-01

Primary Completion

2027-12-31

Completion

2029-12-31

Countries

• Canada

Study Locations