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

Official title

TransfEr of the Lower Trapezius Tendon Versus Partial Cuff Repair Trial - TENET Trial

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.

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).

Primary outcome measures

• Feasibility of Recruitment and Follow-Up [Time frame: 1-year]

Secondary outcome measures (9)

• The Western Ontario Rotator Cuff Score (WORC) [Time frame: 2-years post-operative]
• Constant Score [Time frame: 2-years post-operative]
• American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES) [Time frame: 2-years post-operative]
• Subjective Shoulder Value [Time frame: 2-years post-operative]
• EuroQol EQ-5D-5L [Time frame: 2-years post-operative]
• Functional Range of Motion [Time frame: 2-years post-operative]
• Strength [Time frame: 2-years post-operative]
• Ultrasound [Time frame: 1-year post-operative]
• Reoperation Rate [Time frame: 2-years post-operative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• The Ottawa Hospital — Ottawa

Identifiers

NCT: NCT07051889 · 20250033-01H

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗