60 Participants Needed

Surgical Techniques for Rotator Cuff Tears

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nova Scotia Health Authority
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare the bridging reconstruction technique vs the lower trapezius tendon transfer in patients with massive irreparable rotator cuff tears. The main questions it aims to answer are: * comparing the outcomes of the two surgical techniques (BRR with an acellular human dermal allograft implant vs Arthroscopic Assisted LTT Transfer) on the maintenance of the acromiohumeral distance * compare the outcomes of strength, range of motion, and patient reported quality of life scores between the two techniques Participants will be randomized into one of two surgical treatment groups (bridging reconstruction or lower trapezius tendon transfer) and followed for a minimum of two years to compare the outcomes between groups.

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 data supports the effectiveness of the treatment for rotator cuff tears?

Research shows that lower trapezius tendon transfer, often used in combination with other techniques, can improve shoulder function in patients with massive irreparable rotator cuff tears. This treatment has been found to improve clinical outcomes with a complication rate similar to other surgical options.12345

Is the lower trapezius tendon transfer safe for treating rotator cuff tears?

The lower trapezius tendon transfer for rotator cuff tears has a complication and reoperation rate similar to other surgical options, suggesting it is generally safe.12356

How is the Bridging Reconstruction, Lower Trapezius Transfer treatment different from other treatments for rotator cuff tears?

This treatment is unique because it involves transferring the lower trapezius muscle to help repair massive rotator cuff tears that cannot be fixed by traditional methods. It uses an arthroscopic-assisted technique, which is less invasive, and often includes the use of a tendon graft to improve shoulder function.12347

Eligibility Criteria

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.
Tear size >5cm
<50% muscle atrophy
See 2 more

Exclusion Criteria

Pregnancy
I have stiffness and limited movement in my shoulder.
I have paralysis in my shoulder.
See 8 more

Timeline

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

Treatment Details

Interventions

  • Bridging Reconstruction
  • Lower Trapezius Transfer
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Active Control
Group I: Lower Trapezius Tendon TransferActive Control1 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 RepairActive Control1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials
302
Recruited
95,300+

Findings from Research

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.
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]
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.
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]
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.
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]

References

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. [2023]
Arthroscopic-Assisted Lower Trapezius Tendon Transfer for Massive Irreparable Posterior-Superior Rotator Cuff Tears: Surgical Technique. [2022]
Physiological Tensioning During Lower Trapezius Transfer for Irreparable Posterosuperior Rotator Cuff Tears May Be Important for Improvement in Shoulder Kinematics. [2023]
Outcome of arthroscopically assisted lower trapezius transfer to reconstruct massive irreparable posterior-superior rotator cuff tears. [2021]
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. [2023]
Techniques for lower trapezius tendon transfer for the management of irreparable posterosuperior rotator cuff tears. [2021]
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. [2023]