RecruitingPHASE4INTERVENTIONAL

Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation

This study is investigating a common shoulder problem called a rotator cuff tear, which affects the small tendons that help move your arm. It involves looking at people aged 50 to 75 who have a tear between 3cm and 5cm, which can be fixed with surgery. The main aim is to see if adding a special patch, made from donated human skin, during the repair surgery helps prevent the tear from happening again. We're comparing patients who have the patch added to their repair with those who have the repair without the patch. Everyone will be carefully followed up for a year, including scans, to see how well their shoulder heals and functions. We're also checking the cost-effectiveness of each approach.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

University Hospitals, Leicester

Enrolment target

Start

03 Dec 2021

Estimated completion

31 Dec 2026

Rotator Cuff Tears

What is this study about?

When you have a rotator cuff tear, it means one of the important tendons in your shoulder, which helps you lift and rotate your arm, has been damaged. This can cause pain and make it hard to move your arm properly. Surgery can often fix these tears. However, sometimes, even after surgery, the tendon can tear again.

This study is looking at whether adding a special patch during surgery might help to reduce the chance of the tear coming back. This patch is made from donated human skin that has been specially processed. It's thought that this patch might give the repaired tendon extra support as it heals.

We want to see if people who have the patch added to their shoulder repair have fewer re-tears and better shoulder function after a year than those who have the repair without the patch. This information will help doctors understand the best ways to treat large rotator cuff tears in the future.

Key takeaways

The study is about repairing tears in shoulder tendons.
It compares surgery with and without a special skin patch.
It's for people aged 50-75 with specific shoulder tears.
The aim is to see if the patch stops tears from happening again.
Patients are followed for one year with scans and check-ups.

Who may be eligible?

This study is looking for volunteers between the ages of 50 and 75. You must have a rotator cuff tear in your shoulder that developed over time, not from a recent accident. The tear needs to be a specific size (between 3cm and 5cm) and be something that surgeons believe they can fully repair.

To be considered, scans of your shoulder, like an MRI, must have clearly shown this tear. You also need to be able to understand the study and agree to take part. Since one arm of the study uses a patch made from donated human skin, you must be comfortable with receiving this as part of your treatment.

There are some reasons why you wouldn't be able to join. For instance, if you've had surgery on that shoulder before, or if you have a lot of arthritis in the shoulder. You also can't take part if you have problems with your neck, specific types of arthritis that affect your whole body, or if you can't have an MRI scan. If you have memory or language difficulties, or if a recent injury caused your tear (within the last six months), you wouldn't be eligible either.

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 between 50 and 75 years old?
Do you have a large shoulder tendon tear (diagnosed by MRI)?
Have you NOT had surgery on that shoulder before?
Are you able to have an MRI scan?
Are you comfortable with the idea of a patch made from donated human skin?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have your shoulder tear repaired with surgery. During this surgery, you will be randomly chosen to either receive a special patch added to your repair or have the repair done without the patch. This is like flipping a coin, so neither you nor your doctors can choose which group you're in.

After your surgery, you'll have appointments to check on your recovery. These check-ups will happen at 6 weeks, 3 months, and 12 months after your surgery. During these appointments, we'll assess how your shoulder is feeling and moving. You'll also have an MRI scan of your shoulder 12 months after the surgery to get a detailed look at how well the repair has healed. The total duration of your active participation in the study will be one year.

Potential risks and benefits

Taking part in this study may offer some potential benefits. If the patch proves effective, you might have a reduced chance of your rotator cuff tear re-tearing, which could lead to better long-term shoulder function. However, there's no guarantee of direct benefit for you personally. All surgeries carry risks, such as infection, bleeding, or complications from anaesthesia. There's also a small chance of a reaction to the donated skin patch, although these materials are carefully screened. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hopsitals of Leicester NHS Trust
Verified postcode
Leicester, United Kingdom· Recruiting

Common questions

What is a rotator cuff tear?

It's a common injury where one or more of the tendons around your shoulder, which help you move your arm, are torn.

What is the patch made of?

The patch is made from specially processed, donated human skin, designed to support your own healing tendon.

Will I know if I get the patch?

No, you won't know if you received the patch or not. This is to ensure the study is fair and unbiased.

How long will the study last for me?

You will be followed up for 12 months after your surgery.

What is an MRI scan?

An MRI is a special type of scan that uses strong magnets and radio waves to create detailed pictures inside your body, in this case, of your shoulder.

How to find out more

UHL Sponsor

uhlsponsor@uhl-tr.nhs.uk +44 116 258 8239 (1823) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.