Surgical Techniques for Rotator Cuff Tears
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?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative
Routine radiographs and MRI are obtained; informed consent process
Surgical Treatment
Participants undergo either bridging reconstruction or lower trapezius tendon transfer
Postoperative Recovery
Shoulder immobilized in a sling; passive motion allowed; progression to active motion and strengthening
Follow-up
Participants are monitored for safety and effectiveness; clinical examinations and questionnaires
Treatment Details
Interventions
- Bridging Reconstruction
- Lower Trapezius Transfer
Bridging Reconstruction is already approved in United States, European Union for the following indications:
- Massive irreparable rotator cuff tears
- Massive irreparable rotator cuff tears
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Who Is Running the Clinical Trial?
Nova Scotia Health Authority
Lead Sponsor