Surgical Techniques for Rotator Cuff Tears

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Osteoarthritis, Uncontrolled diabetes, Cancer, others

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

Compensation: Varies

Number of Visits: 11

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two surgical techniques to repair massive rotator cuff tears in the shoulder. It seeks to determine which method—bridging reconstruction using a human dermal implant or lower trapezius tendon transfer—better maintains shoulder space, improves strength, and enhances quality of life. Participants will be randomly assigned to one of these surgeries and monitored for at least two years. Ideal candidates are adults with an MRI-confirmed large rotator cuff tear involving two tendons and measuring over 5 cm, without significant muscle loss or certain other health conditions.

As an unphased trial, this study allows patients to contribute to valuable research that could improve future treatment options.

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.

What prior data suggests that these surgical techniques are safe for treating rotator cuff tears?

Research shows that both surgical techniques in this trial—lower trapezius tendon transfer and bridging reconstruction—are safe options for treating large, irreparable rotator cuff tears.

For the lower trapezius tendon transfer, studies indicate it effectively reduces pain and improves shoulder movement. Patients generally tolerate it well, with no major safety concerns reported.

The bridging reconstruction method uses donated tissue to repair the rotator cuff. Research has found this method helps maintain the repair more often, reducing the chance of failure. It also tends to preserve muscle better, benefiting long-term shoulder function. Patients have reported better outcomes without significant safety issues.

In summary, previous studies have shown both techniques to be generally safe and well-tolerated, with no major safety concerns for either option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these surgical techniques for rotator cuff tears because they offer innovative approaches to repair severe shoulder injuries. The Bridging Reconstruction Repair uses a human dermal allograft, which acts like a scaffold, to bridge and anchor the torn rotator cuff—this is a novel use of biological material to enhance healing and strength. The Lower Trapezius Tendon Transfer involves moving a tendon from the back to the shoulder, utilizing the body's own tissue to restore function and stability, which could improve outcomes compared to traditional repair methods. Both techniques aim to provide more durable and effective solutions for massive rotator cuff tears, potentially reducing the risk of re-injury and enhancing shoulder mobility.

What evidence suggests that these surgical techniques are effective for rotator cuff tears?

This trial will compare two surgical techniques for treating rotator cuff tears. Research has shown that lower trapezius tendon transfer (LTT), one of the techniques studied in this trial, can improve shoulder movement and reduce pain for people with large rotator cuff tears. Studies have found significant improvements in both clinical and functional outcomes after this procedure.

Similarly, bridging reconstruction repair (BRR), the other technique under study, uses a human dermal allograft (a type of tissue implant) and also shows promising results. Research indicates that BRR lowers the risk of structural failure and helps maintain muscle mass better than some other methods. Long-term studies suggest that BRR leads to good outcomes with low rates of further rotator cuff issues over five years. Both techniques offer promising options for people with severe rotator cuff tears. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a confirmed MRI diagnosis of massive rotator cuff tears larger than 5cm, involving two tendons and considered irreparable. Candidates should have less than 50% muscle atrophy. It's not specified who can't join.

Inclusion Criteria

I have a tear in two tendons that cannot be repaired.

<50% muscle atrophy

Tear size >5cm

Exclusion Criteria

Pregnancy

I have stiffness and limited movement in my shoulder.

I have paralysis in my shoulder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative

Routine radiographs and MRI are obtained; informed consent process

1 week

1 visit (in-person)

Surgical Treatment

Participants undergo either bridging reconstruction or lower trapezius tendon transfer

1 day

1 visit (in-person)

Postoperative Recovery

Shoulder immobilized in a sling; passive motion allowed; progression to active motion and strengthening

12 weeks

Follow-up at 2 weeks, 6 weeks, 3 months

Follow-up

Participants are monitored for safety and effectiveness; clinical examinations and questionnaires

24 months

Visits at 6 months, 12 months, 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Bridging Reconstruction
• Lower Trapezius Transfer

Trial Overview The study compares two surgical methods for repairing large to massive rotator cuff tears: bridging reconstruction using an acellular human dermal allograft implant versus arthroscopic assisted lower trapezius tendon transfer, assessing their impact on shoulder distance maintenance, strength, motion range, and quality of life.

How Is the Trial Designed?

Group I: Lower Trapezius Tendon Transfer Active Control 1 Intervention

The lower trapezius tendon transfer arm will consist of patients randomized to this surgical procedure. This is an arthroscopically assisted open procedure that involves harvesting of the lower trapezius muscle tendon and re-grafting it onto to shoulder to repair massive rotator cuff tears.

Group II: Bridging Reconstruction Repair Active Control 1 Intervention

The bridging reconstruction repair arm will consist of patients randomized to this surgical procedure. This operation is arthroscopic, and involves the insertion of a human dermal allograft to the rotator cuff, sutured and anchored in a "bridging" fashion to repair massive rotator cuff tears.

Bridging Reconstruction is already approved in United States, European Union for the following indications:

Approved in United States as Bridging Reconstruction for:

• Massive irreparable rotator cuff tears

Approved in European Union as Bridging Reconstruction for:

• Massive irreparable rotator cuff tears

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Published Research Related to This Trial

The lower trapezius tendon transfer has become a popular surgical option for treating irreparable posterosuperior rotator cuff tears, showing promising results in improving shoulder function, particularly external rotation.

Various surgical techniques for the LT tendon transfer, including open, mini-open, and arthroscopic-assisted methods, provide flexibility in treatment approaches based on patient needs and surgeon preference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques for lower trapezius tendon transfer for the management of irreparable posterosuperior rotator cuff tears. Ghoraishian, M., Stone, MA., Elhassan, B., et al.[2021]

Physiologically tensioned lower trapezius transfer (LTT) significantly improved shoulder movement and reduced the upward migration of the humeral head compared to both undertensioned and overtensioned LTT, indicating that proper tensioning is crucial for effective surgical outcomes.

While LTT improved shoulder kinematics after an irreparable rotator cuff tear, it did not fully restore the shoulder's native function, suggesting that while tensioning is important, other factors may also influence recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological Tensioning During Lower Trapezius Transfer for Irreparable Posterosuperior Rotator Cuff Tears May Be Important for Improvement in Shoulder Kinematics. Muench, LN., Rupp, MC., Obopilwe, E., et al.[2023]

In a study of 16 patients with massive irreparable rotator cuff tears, simultaneous lower trapezius tendon transfer and interpositional repair led to significant improvements in shoulder function, including increased forward flexion, abduction, and external rotation after an average follow-up of 29 months.

The combination of these surgical techniques resulted in improved pain scores and overall shoulder function, as measured by UCLA and Constant-Murley scores, without a significant increase in complications, indicating a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical results of lower trapezius tendon transfer with the peroneus longus allograft augmentation combined with interpositional repair with fascia lata in massive irreparable rotator cuff tears. Bozoğlan, M., Danışman, M., Demir, T., et al.[2023]

In a study of 104 patients with irreparable rotator cuff tears, both arthroscopic superior capsular reconstruction (SCR) and lower trapezius tendon transfer (LTT) showed improved clinical outcomes after surgery, with SCR providing better pain relief and forward elevation strength.

SCR patients reported lower pain scores and greater improvements in forward elevation compared to LTT patients, while LTT was more effective in improving external rotation, indicating that both techniques can be beneficial depending on the specific needs of the patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Yet Varied Clinical Outcomes Observed With Comparison of Arthroscopic Superior Capsular Reconstruction Versus Arthroscopy-Assisted Lower Trapezius Transfer for Patients With Irreparable Rotator Cuff Tears. Marigi, EM., Jackowski, JR., Elahi, MA., et al.[2023]

In a study of 41 patients with irreparable posterior-superior rotator cuff tears, 90% experienced significant improvements in pain and shoulder function after undergoing arthroscopically assisted lower trapezius transfer, with an average follow-up of 14 months.

The presence of a subscapularis tear did not negatively impact the surgical outcomes, although some patients with preoperative shoulder arthropathy experienced persistent issues, highlighting the importance of patient selection for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of arthroscopically assisted lower trapezius transfer to reconstruct massive irreparable posterior-superior rotator cuff tears. Elhassan, BT., Sanchez-Sotelo, J., Wagner, ER.[2021]

Lower trapezius transfer (LTT) significantly improves shoulder function in patients with functionally irreparable rotator cuff tears, with mean gains in forward elevation and external rotation ranging from 10° to 66° and 11° to 63°, respectively, over a follow-up period of 14 to 47 months.

The overall complication rate for LTT was 17.6%, with the most common issue being seroma/hematoma at the harvest site, and a reoperation rate of 7.5%, primarily due to conversions to reverse shoulder arthroplasty, indicating that LTT is a relatively safe option compared to other surgical alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower Trapezius Transfer Improves Clinical Outcomes With a Rate of Complications and Reoperations Comparable to Other Surgical Alternatives in Patients with Functionally Irreparable Rotator Cuff Tears: A Systematic Review. de Marinis, R., Marigi, EM., Atwan, Y., et al.[2023]

The study introduces an innovative arthroscopic-assisted technique for lower trapezius transfer, which is used to reconstruct massive irreparable posterior-superior rotator cuff tears, enhancing the surgical approach previously described.

This technique is augmented with an Achilles tendon allograft, potentially improving the effectiveness of the reconstruction and offering a less invasive option compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic-Assisted Lower Trapezius Tendon Transfer for Massive Irreparable Posterior-Superior Rotator Cuff Tears: Surgical Technique. Elhassan, BT., Alentorn-Geli, E., Assenmacher, AT., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0749806324004894

Bridging Reconstruction With Interpositional Dermal ... BRR results in a significantly reduced structural failure rate and a trend toward better preservation of supraspinatus muscle mass compared with maximal repair.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38986852/

Bridging Reconstruction With Interpositional Dermal ... BRR results in a significantly reduced structural failure rate and a trend toward better preservation of supraspinatus muscle mass compared with maximal repair.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40089011/

Bridging reconstruction for massive rotator cuff tears has a ... The results of this study show that BRR with dermal allograft has promising results over a 5-year follow-up with low progression to rotator ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1058274625002125

Bridging reconstruction for massive rotator cuff tears has a ... The results of this study show that BRR with dermal allograft has promising results over a 5-year follow-up with low progression to rotator cuff arthropathy and ...

5. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(25)00212-5/fulltext

Bridging Reconstruction for Massive Rotator Cuff Tears has ... The results of this study show that bridging reconstruction with dermal allograft has promising results over a 5-year follow-up with low ...

6. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(21)00729-5/abstract

Interposition Graft Bridging Reconstruction of Irreparable ... A retrospective chart review was conducted for all patients who underwent bridging reconstruction between 2010 and 2018.

7. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(25)00268-3/fulltext

Bridging Reconstruction Using a Biocomposite Scaffold for ... This technical video shows arthroscopic rotator cuff repair with bridging reconstruction using the BioBrace (Biorez) graft in the right shoulder ...

8. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/03635465211039846

Bridging Allograft Reconstruction Is Superior to Maximal ... Rotator cuff bridging reconstruction using a dermal allograft demonstrated improved patient-reported outcomes as measured using the WORC index 2 years ...