Massive Rotator Cuff TearTENETNCT07051889
Lower Trapezius Tendon Transfer vs Partial Cuff Repair in Massive Rotator Cuff Tears
A study testing Lower Trapezius Tendon Transfer and Partial Rotator Cuff Repair in people with Massive Rotator Cuff Tear, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Massive Rotator Cuff Tear
- What is being tested?
- Lower Trapezius Tendon Transfer and Partial Rotator Cuff Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Katie McIlquham, 613-737-8899 ext. 79839, kmcilquham@ohri.ca
Peter Lapner, MD FRCSC
About this study
Official title: 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.
Read more
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
- Being tested
- Lower Trapezius Tendon Transfer, Partial Rotator Cuff Repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Trapezius Tendon TransferProcedure or surgery
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 or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Partial Rotator Cuff Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-year
Secondary outcomes (9)
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.
Measured: 2-years post-operative
Constant Score
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).
Measured: 2-years post-operative
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)
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.
Measured: 2-years post-operative
Subjective Shoulder Value
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.
Measured: 2-years post-operative
EuroQol EQ-5D-5L
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.
Measured: 2-years post-operative
Functional Range of Motion
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.
Measured: 2-years post-operative
Strength
Measured using a dynamometer, and from the external rotation in neutral position. Strength will be reported in pounds.
Measured: 2-years post-operative
Ultrasound
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).
Measured: 1-year post-operative
Reoperation Rate
The number of reoperations will be monitored and recorded and compared between study groups. A higher rate of reoperations indicates a worse outcome.
Measured: 2-years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massive Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Orthopaedic Foundation
- Responsible party
- Sponsor
- Investigators
- Peter Lapner, MD FRCSC, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051889
- Sponsor's protocol ID
- 20250033-01H
- Acronym
- TENET
- Status last verified
- Jul 2025
- First submitted
- 9 May 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TransfEr of the Lower Trapezius Tendon Versus Partial Cuff Repair Trial - TENET Trial
- ClinicalTrials.gov ID
- NCT07051889
- Acronym / sponsor ID
- TENET / 20250033-01H
- Conditions
- Massive Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Orthopaedic Foundation
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower Trapezius Tendon Transfer | Active comparator | Procedure: Lower Trapezius Tendon TransferThe 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. |
| Partial Rotator Cuff Repair | Active comparator | Procedure: Partial Rotator Cuff RepairThe rotator cuff repair procedure involves reattaching the torn tendon(s) back to the upper part of the arm bone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Features of irreparability of their rotator cuff tendon tear including:
- 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
Key exclusion criteria (9 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower Trapezius Tendon TransferThis 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 or surgery | Lower Trapezius Tendon Transfer |
| Partial Rotator Cuff RepairThis 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). | Procedure or surgery | Partial Rotator Cuff Repair |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Lapner, MD FRCSC principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower Trapezius Tendon Transfer and Partial Rotator Cuff Repair in people with Massive Rotator Cuff Tear, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie McIlquham (613-737-8899 ext. 79839, kmcilquham@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Recruitment and Follow-Up (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.