RecruitingOBSERVATIONAL

Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant

This study is gathering real-world information about a new surgical implant called REGENETEN. It's used during a common shoulder operation to fix tears in the rotator cuff, which are the muscles and tendons that help you lift and rotate your arm. The aim is to see how patients heal and manage their pain up to two years after surgery when this implant is used. Up to 400 patients from the UK, Europe, and Australia will take part. Everyone in the study will receive the REGENETEN implant and their usual medical care. The goal is to understand if this implant helps people get better results after their rotator cuff repair.

At a glance

Status

Recruiting

Sponsor

Smith & Nephew, Inc.

Enrolment target

400

Start

01 Oct 2020

Estimated completion

31 Dec 2029

Rotator Cuff Injuries

What is this study about?

This study is designed to learn more about a new implant called REGENETEN. It's used during an operation to repair a torn rotator cuff in the shoulder. The rotator cuff is a group of muscles and tendons that surround the shoulder joint, helping you lift and rotate your arm. When it tears, it can cause pain and weakness.

Doctors want to observe how people recover after their surgery when this particular implant is used. They'll be looking at things like pain levels and how well people can move their arm over two years. This is a "real-world" study, which means it's watching what happens to patients during their normal care, rather than changing their treatment.

The information collected from patients will help doctors understand the longer-term results of using the REGENETEN implant. This can help improve care for future patients needing rotator cuff repair.

Key takeaways

This study is collecting information on a new shoulder implant (REGENETEN).
It aims to see how patients recover after rotator cuff surgery using this implant.
Participation involves having your planned surgery and follow-up care as usual.
Information will be gathered for up to two years after your operation.
Your regular medical care will not be changed by joining this study.

Who may be eligible?

To join this study, you must be having surgery to fix a torn rotator cuff using a keyhole method (arthroscopic surgery). You need to be 18 years old or older when you agree to take part, and you must provide some basic information before your surgery starts. Both small and large tears in the rotator cuff are included.

There are some reasons why you wouldn't be able to join. If a doctor believes that a health condition, like a severe mental health issue or problems with alcohol or drugs, would make it hard for you to participate fully in the study, then you wouldn't be able to take part. Also, if the REGENETEN implant isn't suitable for your specific medical situation according to its official guidelines, you wouldn't be included.

Finally, if you are considered a 'vulnerable' person according to strict medical research rules (for example, if you're in a situation where it might be harder for you to say no to taking part), you would not be able to join this study. This is to protect people who might be at higher risk.

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?
Are you having keyhole surgery for a torn rotator cuff?
Is the REGENETEN implant suitable for your shoulder injury?
Do you feel able to take part in a study and provide information about your recovery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have your rotator cuff repair surgery with the REGENETEN implant, as planned by your surgeon. You will receive all your usual medical care before, during, and after your operation. The study team will simply be collecting information about your recovery. This includes details gathered during your regular check-ups and any follow-up appointments with your surgeon or physiotherapist. They will be keen to see how you are getting on for up to two years after your surgery.

Potential risks and benefits

There are no significant extra risks involved in taking part in this study beyond those normally associated with rotator cuff repair surgery itself and receiving the REGENETEN implant as part of your treatment. The potential benefit is that the information gathered from your experience will help doctors better understand the long-term effectiveness of the REGENETEN implant, potentially improving care for future patients. You are free to withdraw from the study at any time without affecting your medical care.

Locations (22)

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

Melbourne Orthopaedic Group
Verified postcode
Windsor, Australia· Recruiting
Schoen Klinik Lorsch
Verified postcode
Lorsch, Germany· Recruiting
Schoen Klinik Dusseldorf
Verified postcode
Düsseldorf, Germany· Recruiting
Malteser Waldkrankenhaus Erlangen
Verified postcode
Erlangen, Germany· Recruiting
Sporthopaedie Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting
St. Anna Hospital
Verified postcode
Herne, Germany· Recruiting
Artemed Klinikum München Süd
Verified postcode
München, Germany· Recruiting
OrthoMedicum Mittelhessen
Verified postcode
Stadtallendorf, Germany· Recruiting
Regional General Hospital F. Miulli
Verified postcode
Acquaviva delle Fonti, Italy· Recruiting
Ospedale Israelitico
Verified postcode
Roma, Italy· Recruiting
Ospedale di Sassuolo
Verified postcode
Sassuolo, Italy· Recruiting
Manchester University NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is a rotator cuff injury?

It's when the group of muscles and tendons surrounding your shoulder joint gets torn or damaged, making it hard to lift and rotate your arm.

What is the REGENETEN implant?

It's a special implant used during shoulder surgery to help repair and support the torn rotator cuff tissue.

Will I get extra treatment if I join this study?

No, you will receive your standard medical care and surgery. The study is simply observing your recovery.

How long will the study follow me?

The study will collect information about your recovery for up to two years after your surgery.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating at any time without it affecting your medical care.

How to find out more

Cat Whittall

catherine.whittall@smith-nephew.com +44 7841868997 Official trial record

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