Lower Trapezius Tendon Transfer vs Partial Cuff Repair for Rotator Cuff Tears

(TENET Trial)

Overseen By Katie McIlquham

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Subscapularis tears, Shoulder injuries, Surgery history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure with immediate post-operative care

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two surgical methods for treating massive rotator cuff tears in the shoulder, which can cause significant pain and limit movement. One method, Lower Trapezius Tendon Transfer, transfers a tendon from the trapezius muscle to help restore shoulder function. The other method involves partially repairing the torn rotator cuff. The trial aims to determine which method more effectively improves shoulder function and reduces pain. Suitable candidates for this trial include individuals diagnosed with massive rotator cuff tears that cannot be fully repaired and who experience difficulty with shoulder movement. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially find relief from shoulder pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that transferring the lower trapezius tendon safely treats large tears in the shoulder's rotator cuff. Research indicates that patients with these injuries generally respond well to this treatment, making it a promising alternative to other options.

For partial rotator cuff repair, studies have found that patients might experience local issues, such as pain or stiffness, within two years after surgery. The risk of these issues is about 29.1%. Despite this, the procedure is widely used and generally considered safe.

Both treatments carry some risks, but patients usually tolerate them well. Always consult a doctor to determine the best option for your situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer innovative approaches to repairing rotator cuff tears. The Lower Trapezius Tendon Transfer is unique because it uses the lower trapezius tendon to replace the damaged rotator cuff tendon, potentially offering better shoulder stability by leveraging a tendon that's naturally suited for shoulder movement. On the other hand, Partial Rotator Cuff Repair focuses on reattaching torn tendons to the arm bone, which might be less invasive than full repair strategies. Both methods provide promising alternatives to standard treatments like full rotator cuff repair, which can be more extensive and carry longer recovery times.

What evidence suggests that this trial's treatments could be effective for rotator cuff tears?

This trial will compare two procedures for treating rotator cuff tears: lower trapezius tendon transfer and partial rotator cuff repair. Research has shown that the lower trapezius tendon transfer can greatly improve shoulder function in people with large rotator cuff tears. Studies have found that this procedure helps with shoulder movements like turning the arm outward and lifting it forward, which are important for everyday tasks. For example, patients' scores on the American Shoulder and Elbow Surgeons scale, which measures shoulder performance and pain, improved from 54.8 to 84.8 after the procedure.

Meanwhile, partial rotator cuff repair has also proven effective. In one study, the UCLA shoulder score, which assesses shoulder pain and function, increased from an average of 9.8 before surgery to 27.6 afterward. Both treatments in this trial aim to reduce pain and improve shoulder function, offering promising options for those with severe shoulder tendon tears. ^{1 2 6 7 8}

Who Is on the Research Team?

Peter Lapner, MD FRCSC

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

This trial is for older patients with massive, irreparable rotator cuff tears without significant shoulder arthritis. Candidates should be suitable for joint salvage treatment. Specific eligibility details are not provided but typically include factors like age, overall health, and the extent of the shoulder injury.

Inclusion Criteria

MRI confirmed diagnosis of massive rotator cuff tears defined using the Schumaier 2020 definition

Presence of an external rotation lag on clinical exam

Provision of informed consent

Exclusion Criteria

Patients with concomitant injuries of the affected shoulder

I have a complete tear in my shoulder muscle.

I have a significant shoulder condition, like a Bankart lesion or arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either lower trapezius tendon transfer or partial rotator cuff repair

Surgical procedure with immediate post-operative care

Follow-up

Participants are monitored for safety, effectiveness, and clinical outcomes

1 year

Regular follow-up visits

Extended Follow-up

Participants are assessed for long-term outcomes including shoulder function and reoperation rates

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Lower Trapezius Tendon Transfer
• Partial Rotator Cuff Repair

Trial Overview The study compares two surgical options: lower trapezius tendon transfer and partial rotator cuff repair combined with biceps tenodesis/tenotomy. It's a pilot study to check if a full-scale trial would work across multiple sites in Canada and one in the US.

How Is the Trial Designed?

Group I: Lower Trapezius Tendon Transfer Active Control 1 Intervention

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.

Group II: Partial Rotator Cuff Repair Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Canadian Orthopaedic Foundation

Collaborator

Trials

15

Recruited

1,900+

Citations

1. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/138668-evaluating-the-efficacy-of-trapezius-transfer-in-the-management-of-massive-rotator-cuff-tears-a-systematic-review-of-clinical-outcomes

Evaluating the Efficacy of Trapezius Transfer in ... This review highlights the effectiveness of lower trapezius tendon transfer, particularly using an Achilles allograft, in enhancing pain relief, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12301094/

Evaluating the Efficacy of Trapezius Transfer in the ... This review highlights the effectiveness of lower trapezius tendon transfer, particularly using an Achilles allograft, in enhancing pain relief, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806325002889

Systematic Review Lower Trapezius Tendon Transfer ... Postoperative American Shoulder and Elbow Surgeons scores ranged from 54.8 to 84.8, with absolute improvements of 21.7 to 48.6, whereas visual ...

4. jsesreviewsreportstech.org jsesreviewsreportstech.org/article/S2666-6391(25)00118-X/fulltext

The clinical and biomechanical applications of the lower ... Analysis of the identified studies demonstrates significant improvements in external rotation, forward flexion, and abduction following LT ...

5. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(25)00288-9/abstract

Lower Trapezius Tendon Transfer Improves Range of ... Postoperative American Shoulder and Elbow Surgeons scores ranged from 54.8 to 84.8, with absolute improvements of 21.7 to 48.6, whereas visual ...

6. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(23)00539-6/abstract

Outcomes after arthroscopically assisted lower trapezius ... The purpose of this study was to evaluate early tendon transfer healing using postoperative MRI scans and to assess early clinical outcomes in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10426520/

Lower trapezius tendon transfer for irreparable rotator cuff ... There have been few studies reporting the outcomes of lower trapezius tendon (LTT) transfer for irreparable rotator cuff injuries.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2059775421001310

Arthroscopic lower trapezius tendon transfer provides ... Arthroscopic-assisted lower trapezius tendon transfer is a safe alternative in the treatment of massive irreparable rotator cuff tears.