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

NCT07051889 | Not Yet Recruiting

• 1 other identifier: 20250033-01H
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  1-year

Secondary Outcomes (9)

• The Western Ontario Rotator Cuff Score (WORC)

  2-years post-operative

• Constant Score

  2-years post-operative

• American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)

  2-years post-operative

• Subjective Shoulder Value

  2-years post-operative

• EuroQol EQ-5D-5L

  2-years post-operative

Study Arms (2)

Lower Trapezius Tendon Transfer

ACTIVE COMPARATOR

The Lower Trapezius Tendon Transfer procedure involves transferring one of the other tendons located just outside the shoulder (the 'lower trapezius') and attaching this to the upper part of the arm bone, in the place of the torn rotator cuff tendon.

Procedure: Lower Trapezius Tendon Transfer

Partial Rotator Cuff Repair

ACTIVE COMPARATOR

The rotator cuff repair procedure involves reattaching the torn tendon(s) back to the upper part of the arm bone.

Procedure: Partial Rotator Cuff Repair

Interventions

Lower Trapezius Tendon Transfer PROCEDURE

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.

Lower Trapezius Tendon Transfer

Partial Rotator Cuff Repair PROCEDURE

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).

Partial Rotator Cuff Repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Orthopaedic Foundation: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Study Officials

• Peter Lapner, MD FRCSC

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie McIlquham

CONTACT

613-737-8899; kmcilquham@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: July 4, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)