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

July 2, 2025 updated by: Ottawa Hospital Research Institute

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital
        • Contact:
        • Principal Investigator:
          • Peter Lapner, MD FRCSC
        • Sub-Investigator:
          • J W Pollock, MD MSc FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Lower Trapezius Tendon Transfer
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
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.
Active Comparator: Partial Rotator Cuff Repair
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
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of Recruitment and Follow-Up
Time Frame: 1-year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Western Ontario Rotator Cuff Score (WORC)
Time Frame: 2-years post-operative
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.
2-years post-operative
Constant Score
Time Frame: 2-years post-operative
The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points. The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).
2-years post-operative
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)
Time Frame: 2-years post-operative
The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
2-years post-operative
Subjective Shoulder Value
Time Frame: 2-years post-operative
A participant's subjective value on shoulder function will be assessed using a questionnaire. The overall functional value of the shoulder is written as a percentage from 0-100% of a normal shoulder. The higher the score, the better the outcome.
2-years post-operative
EuroQol EQ-5D-5L
Time Frame: 2-years post-operative
The EQ-5D-5L quality of life questionnaire is a brief, easy to administer generic health status questionnaire, consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses (each question rated 1-5), lower scores indicate better outcome. It also includes a visual analogue scale for recording an individual's rating of their current health-related quality of life (scale 0 to 100), where a higher score indicates a better outcome.
2-years post-operative
Functional Range of Motion
Time Frame: 2-years post-operative
Measured in degrees, and active movement. Range of motion measures include forward elevation (flexion), abduction, and external rotation from a neutral position, and internal rotation at the spinal level.
2-years post-operative
Strength
Time Frame: 2-years post-operative
Measured using a dynamometer, and from the external rotation in neutral position. Strength will be reported in pounds.
2-years post-operative
Ultrasound
Time Frame: 1-year post-operative
Ultrasound will be used to evaluate tendon healing rate after the repair or the transfer and assess for integrity. If the repair/transfer has healed it is considered a better outcome (tendon healing - yes/no).
1-year post-operative
Reoperation Rate
Time Frame: 2-years post-operative
The number of reoperations will be monitored and recorded and compared between study groups. A higher rate of reoperations indicates a worse outcome.
2-years post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Hospital Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Orthopaedic Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Lapner, MD FRCSC, The Ottawa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20250033-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will be be shared with other researchers unless requested and an agreement is in place. Only aggregate data will be made public (overall study results).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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