RecruitingNAINTERVENTIONAL

Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears

The REGENETEN™ Bioinductive Implant System is being tested to see if it can help people with a specific type of shoulder tendon tear recover more quickly. This study is for those who have a significant partial tear in their rotator cuff (the group of muscles and tendons around your shoulder joint) and have already tried other treatments for at least three months without success. We want to find out if using this implant allows people to return to their everyday routines faster than the usual surgical repair. This research will compare the new implant (called "Isolated Bioinductive Repair") with the standard surgery (called "Completion and Repair") to see which one leads to a better and quicker recovery after three months.

At a glance

Status

Recruiting

Phase

Sponsor

Smith & Nephew, Inc.

Enrolment target

234

Start

30 Aug 2022

Estimated completion

30 Jun 2028

Rotator Cuff Injuries

What is this study about?

This research study is looking into a new way to treat a common shoulder injury called a rotator cuff tear. Your rotator cuff is a group of muscles and tendons that help you lift and rotate your arm. Sometimes, these tendons can get torn, especially if you use your arm a lot for overhead activities or if you're getting older. This study focuses on tears that are quite significant but not completely torn through – medical professionals call these "high-grade partial-thickness tears."

The study wants to understand if a special implant, called the REGENETEN™ Bioinductive Implant, can help these tears heal better and allow people to get back to their normal activities more quickly. This implant is designed to help your body's own healing process. Researchers are comparing it to the standard surgery, where the torn part of the tendon is usually stitched back together. The main goal is to see if, after three months, patients who receive the implant recover their shoulder function better than those who have the traditional surgery.

By comparing these two methods, doctors hope to find the best way to help people with this type of shoulder injury recover faster and more fully. This could mean less time in pain and a quicker return to hobbies, work, and daily life. The study aims to provide clear information on which treatment approach offers the most benefits for patients.

Key takeaways

This study compares a new shoulder implant (REGENETEN™) with standard surgery for specific partial tendon tears.
The goal is to see if the implant helps people recover faster and get back to daily activities sooner.
It's for people aged 18 and over with a significant partial rotator cuff tear who haven't improved with other treatments.
You'll be part of a group that receives either the implant or standard surgery, decided by chance.
Participation involves surgery and several follow-up appointments to monitor your progress.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and willing to give your written consent to take part. You must have a specific type of partial tear in your supraspinatus tendon, or in both your supraspinatus and infraspinatus tendons, which are part of your rotator cuff. This tear needs to be quite substantial (more than half of the tendon's thickness) and you should have already tried other treatments like exercise or physical therapy for at least three months without much improvement.

There are also some reasons why you might not be able to join. For example, if your tendon tissue is not strong enough for the implant, or if you have severe arthritis in your shoulder. You also can't have had any infections in that shoulder or previous surgery on it. If you've had steroid injections in the last three months, or if you have other conditions like inflammatory arthritis, you might not be suitable. This study is not for people with completely torn tendons or other specific shoulder problems that would need different types of repair.

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 or older?
Do you have a significant partial tear in your shoulder's supraspinatus tendon (or with infraspinatus)?
Have you tried exercises or physical therapy for your shoulder for at least 3 months without full success?
Have you *not* had previous surgery on that same shoulder?
Do you *not* have severe arthritis, infection, or other inflammatory conditions in your shoulder?
Are you able and willing to attend all required study visits?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have surgery on your shoulder. You will be randomly assigned to receive either the new REGENETEN™ implant or the standard surgical repair; you won't get to choose which one. After the surgery, you'll need to attend several follow-up appointments at specific times to check on your recovery. This will involve physical examinations and probably filling out questionnaires about how your shoulder feels and how well you can use it. The study will monitor your progress for a certain period to compare the healing and recovery between the two treatment groups. The total duration of your participation in the study will depend on the follow-up schedule designed to capture long-term recovery.

Potential risks and benefits

Participating in this study might offer the benefit of potentially recovering faster from your shoulder injury if the new implant proves more effective than standard surgery. However, as with any surgery, there are always risks, such as infection, pain, or complications from the procedure itself. You will also be asked to attend multiple follow-up visits, which requires a time commitment. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (20)

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

Harbin Clinic
Verified postcode
Rome, United States· Recruiting
OrthoIllinois LTD
Verified postcode
Rockford, United States· Recruiting
Sinai Hospital Baltimore
Verified postcode
Baltimore, United States· Withdrawn
Cleveland Clinic - Sports Health
Verified postcode
Garfield Heights, United States· Withdrawn
University of Pittsburgh
Verified postcode
Pittsburgh, United States· Recruiting
Texas Orthopedic Specialists
Verified postcode
Bedford, United States· Recruiting
Houston Methodist The Woodlands
Verified postcode
The Woodlands, United States· Withdrawn
Memorial Medical Center
Verified postcode
Ashland, United States· Withdrawn
OrthoSport Victoria
Verified postcode
Richmond, Australia· Recruiting
Access Orthopaedics
Verified postcode
Calgary, Canada· Recruiting
Pan Am Clinic
Verified postcode
Winnipeg, Canada· Recruiting
Research St. Joseph's
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What is a rotator cuff tear?

It's an injury to one or more of the tendons that connect your shoulder muscles to your arm bone, helping you lift and rotate your arm.

What does 'partial-thickness tear' mean?

It means the tendon is torn, but not completely separated. This study focuses on tears that are more than 50% of the tendon's thickness.

What is the REGENETEN™ Bioinductive Implant?

It's a special implant designed to help your body's own healing process for a partially torn shoulder tendon.

Will I know if I get the implant or the standard surgery?

No, you will be randomly assigned to one group or the other, like drawing lots, so neither you nor your doctor will know during the study period.

How long will the study last for me?

You will have surgery, then regular follow-up visits for a set period to check your recovery. The detailed timeline will be explained by the study team.

How to find out more

Alice Kitching

alice.kitching@smith-nephew.com +44 (0) 7590001182 Official trial record

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