RecruitingNAINTERVENTIONAL

Lok™ Suture Anchors Safety & Performance Trial

This study is looking at how well new Lok™ suture anchors and their tools from Move-Up work for people with certain shoulder problems. These problems include tears in the rotator cuff (muscles and tendons around the shoulder joint) or injuries to the labrum (a rim of cartilage in the shoulder). The main goal is to see if these devices are safe and effective. Participants will have their shoulder recovery checked at about 3, 6, and 12 months after surgery using different scoring systems for pain and shoulder function. At the 6 and 12-month marks, researchers will also use ultrasound scans to see how well the tendons are healing. They will also keep an eye out for any problems or side effects throughout the study.

At a glance

Status

Recruiting

Phase

Sponsor

Move Up SAS

Enrolment target

216

Start

05 Mar 2026

Estimated completion

01 Aug 2027

Rotator Cuff Tears of the Shoulder Labrum Injury

What is this study about?

This study is about a new type of medical device called Lok™ suture anchors, made by a company called Move-Up. Suture anchors are small devices used in surgery to help reattach torn tissues, like tendons or ligaments, to bone. In this case, they are being used for people who have certain shoulder injuries, such as tears in the rotator cuff (the group of muscles and tendons that surround the shoulder joint) or injuries to the labrum (a ring of cartilage that helps keep the arm bone in its socket).

The main purpose of this study is to find out if these Lok™ anchors are safe to use and if they work well to help people recover from their shoulder injuries. The researchers will closely follow patients after their surgery using these anchors to see how their shoulder heals and how much pain they have. They want to make sure the anchors help the tissues heal properly and that patients get back good movement and comfort in their shoulder.

Over a year, the study team will collect information to see how well patients are doing. This includes using special questionnaires and scales to measure pain, how well the shoulder works, and a patient’s overall satisfaction. They will also use ultrasound scans, a type of imaging like an X-ray but using sound waves, to check inside the shoulder and see how the tendons are healing. They'll also carefully record any unexpected problems or side effects that might happen during the study.

Key takeaways

This study tests new Lok™ suture anchors for shoulder injuries.
It aims to check the safety and effectiveness of these devices.
Participants will be followed for about 12 months after surgery.
Recovery, pain, and healing will be assessed using scores and scans.
It's for specific shoulder issues like rotator cuff tears and shoulder instability.

Who may be eligible?

To join this study, you need to be an adult (age 18 or older) with full bone growth. You must have one of these specific shoulder problems: a rotator cuff tear linked to an issue with your biceps tendon, shoulder instability (your shoulder feels loose or dislocates), or a specific type of partial tendon tear called a PASTA lesion. Doctors will confirm these injuries using special scans like an MRI or an arthrogram.

There are also reasons why you wouldn't be able to join. These include if you have a broken shoulder bone, a major recent shoulder injury, or an active infection. Conditions like inflammatory joint disease, severe arthritis in your shoulder, or bone problems that would make it hard for the anchor to attach properly would also exclude you. If you have any allergies to the materials used in the anchors, or if you've had previous surgery on the same shoulder joint space, you wouldn't be eligible.

Additionally, you can't be pregnant or breastfeeding, in prison, or unable to understand or follow the study instructions (including if you can't speak or read French). If you have a serious medical or mental health condition that would prevent you from taking part safely or giving informed consent, or if you're already in another clinical trial, you wouldn't be able to participate.

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 a rotator cuff tear, shoulder instability, or a specific tendon/cartilage injury confirmed by scans?
Have you *not* had a recent major shoulder injury, severe arthritis, or an active infection?
Are you able to speak/read English and complete questionnaires?
Are you *not* pregnant or breastfeeding?
Are you *not* currently in another clinical trial?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have surgery to repair your shoulder injury using the Lok™ suture anchors. After your surgery, you will have several follow-up appointments. These visits will be at about 1, 3, 6, and 12 months after your operation.

During these appointments, the study team will check how you are recovering. This will involve answering questionnaires about your pain levels and how well your shoulder is moving and functioning. At the 6-month and 12-month visits, you will also have an ultrasound scan of your shoulder. This scan helps the doctors see how well your tendons are healing inside. The overall duration of your participation in the study, from surgery to the last follow-up, will be about 12 months.

Potential risks and benefits

Participating in any study has potential benefits and risks. A potential benefit of this study is that you would receive surgical treatment for your shoulder injury using a new medical device. Your recovery will also be closely monitored by a medical team. However, there are potential risks associated with any surgery, including infection, pain, and issues with healing. There's a chance the new device might not work as expected or could have side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Alixan
Verified postcode
Valence, France· Recruiting

Common questions

What kind of shoulder injuries is this study for?

This study is for people with rotator cuff tears, certain biceps tendon problems, shoulder instability (loose shoulder), or a specific cartilage injury called a PASTA lesion.

What are Lok™ suture anchors?

They are small medical devices used during surgery to reattach torn tendons or ligaments to bone in the shoulder.

How long will I be in the study?

You'll be in the study for about 12 months after your surgery, with a few follow-up visits during that time.

What will happen at the follow-up visits?

Doctors will check your pain, how your shoulder moves, and your overall recovery. You'll also have ultrasound scans at some visits to check healing.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without it affecting your medical care.

How to find out more

Manal OUBOUKHA, Clinical affairs manager

manal.ouboukha@move-ortho.com 33 677 096 697 Official trial record

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