Lower Trapezius Transfer vs Bridging Reconstruction
This study is looking at two different surgical ways to fix very large, untreatable tears in the shoulder's rotator cuff. Researchers want to compare a method called 'bridging reconstruction' with another called 'lower trapezius tendon transfer'. The goal is to find out which surgery works better at maintaining the shoulder's position, improving arm strength and movement, and ultimately making patients feel better. Participants will be randomly assigned to one of these two surgeries and their progress will be checked for at least two years to see which approach gives the best results.
At a glance
What is this study about?
If you have a very large tear in your shoulder's rotator cuff that can't be easily fixed, doctors are always looking for the best ways to help. This study is like a careful comparison test between two different types of surgery that could help people with these kinds of severe shoulder injuries. One surgery is called 'bridging reconstruction', where a special patch made from human skin is used to help repair the tear. The other is called 'lower trapezius tendon transfer', which involves moving a tendon from your upper back (the lower trapezius muscle) to help your shoulder work better.
The main idea is to see how well each surgery keeps your shoulder joint stable and helps you move your arm. They also want to understand if one surgery makes your arm stronger, helps you move it more freely, and improves your overall daily life and comfort more than the other. By comparing these two methods, doctors hope to learn which one is most effective for people with these challenging shoulder problems.
Taking part in this study would mean you'd be randomly chosen for one of these two surgeries. Then, a team of expert doctors would carefully check your progress for at least two years. This helps them thoroughly understand the long-term benefits and differences between the two surgical approaches, leading to better treatments for future patients.
Key takeaways
- Compares two different surgeries for large, untreatable shoulder tears.
- Aims to find out which surgery is more effective for improving shoulder function.
- Participants will be randomly assigned to one of the two surgical groups.
- Follow-up will continue for a minimum of two years after surgery.
- Could help improve future treatments for severe rotator cuff tears.
Who may be eligible?
To be able to take part in this study, you would need to be an adult (18 years or older) and have a very large rotator cuff tear in your shoulder that doctors have confirmed with an MRI scan. This tear should be at least 5cm in size and involve two tendons that can't be easily fixed. Your shoulder muscles should also not be too wasted away.
However, some things would mean you couldn't join. For example, if you have a certain type of tear in another shoulder tendon (the subscapular tear) that can't be fixed, or if you have arthritis in your shoulder joint. Also, if you have very poor shoulder movement where your arm is 'frozen', suffer from uncontrolled diabetes, are pregnant, have an infection, or have certain conditions like cancer or paralysis, you wouldn't be able to participate. You also need to be able to understand and follow instructions after the surgery.
Finally, if you already have a very good quality of life despite your shoulder issue (as measured by a specific questionnaire), or if you can't give your clear agreement to be part of the study, you wouldn't be able to join.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have an MRI-confirmed very large rotator cuff tear (over 5cm) involving two tendons?
- Do you NOT have severe shoulder arthritis or uncontrolled diabetes?
- Are you NOT pregnant and do you NOT have any active infections or cancer?
- Can you understand and follow instructions for your recovery?
- Is your shoulder NOT 'frozen' (contracture) or paralysed?
What does participation involve?
If you decide to join this study, first you'll have a meeting to make sure you understand everything involved and give your permission. Before any surgery, you'll have regular shoulder X-rays and an MRI scan, which are standard for this type of problem. You'll also have a thorough check-up by a specialist doctor. This will involve measuring your arm movement with special tools and checking your strength with a hand-held device. You'll also fill out a questionnaire about your shoulder and how it affects your life.
You will then be randomly assigned by a computer to one of the two surgery groups: either the 'bridging reconstruction' or the 'lower trapezius tendon transfer'. You won't get to choose which one you receive. After your surgery, doctors will continue to check your progress for at least two years. This will involve follow-up appointments and tests to see how well your shoulder is recovering and how you're feeling overall.
Potential risks and benefits
Locations (1)
- 5955 Veterans' Memorial Lane Room 2106, VMBVerified postcodeHalifax, Canada· Recruiting
Common questions
What is a 'rotator cuff tear'?
It's a tear in the group of muscles and tendons that surround your shoulder joint, helping you lift and rotate your arm.
What does 'irreparable' mean in this context?
It means the tear is so large or severe that standard surgical methods to stitch it back together might not work well or aren't possible.
What's the difference between the two surgeries being studied?
One uses a special patch to help bridge the gap in the torn tendons, and the other involves moving a healthy tendon from your back to your shoulder to help it function.
Will I get to choose which surgery I have?
No, a computer will randomly choose which surgery you receive, like flipping a coin, to make sure the study is fair.
How long will I be followed in this study?
You will be carefully monitored by the study team for at least two years after your surgery.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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