RecruitingOBSERVATIONAL

PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)

This study is gathering important information about a medical device called The Tether™, used for young people with a progressive curve in their spine, a condition known as idiopathic scoliosis. It's not a study where doctors are trying new treatments; instead, it's observing how The Tether™ works in patients who are already having this surgery as part of their standard care. The main goals are to make sure the device is safe and to understand its benefits over time. If you have this surgery and take part in the study, you'll simply attend your usual follow-up appointments over five years, and the study will collect information during these visits. This helps medical teams learn more about The Tether™ to help future patients.

At a glance

Status

Recruiting

Sponsor

LDR Médical SAS

Enrolment target

100

Start

18 Jul 2024

Estimated completion

01 Dec 2033

Scoliosis Idiopathic

What is this study about?

This study is looking at a device called The Tether™, which is used to treat a condition called idiopathic scoliosis. Idiopathic scoliosis means a curve in the spine that develops without a known cause, often in children and teenagers. The Tether™ is a special system designed to help straighten the spine. This particular study isn't about testing a new treatment or asking patients to do anything extra. Instead, it's an 'observational' study, meaning doctors are simply watching and collecting information on how The Tether™ works in patients who have already decided to have this surgery as part of their regular medical care.

The main purpose of this study is to understand two key things: how safe The Tether™ device is for patients and how much benefit it provides in the long term. By collecting information from many patients over several years, doctors can get a much clearer picture of how well The Tether™ helps young people with curved spines. This kind of information is really important because it helps improve care for everyone with scoliosis in the future.

Patients taking part will simply have their usual follow-up appointments after their surgery. The study will collect information during these routine visits. This information helps medical experts ensure the device is working as expected and identify any areas where improvements might be made. It's a way of continuously learning and improving care for young people with scoliosis who have this specific type of surgery.

Key takeaways

This study observes how The Tether™ device works for scoliosis.
It aims to understand the device's safety and benefits over 5 years.
Participation means attending your regular follow-up appointments.
Your medical treatment will not change if you join.
The study helps improve care for future patients with scoliosis.

Who may be eligible?

This study is looking for young people aged 0 to 30 years old. To be able to take part, you would need to have been diagnosed with a type of progressive idiopathic scoliosis where your spine curve is between 30 and 65 degrees. Importantly, your bones should still be growing (meaning you're 'skeletally immature'), and other treatments like wearing a brace haven't worked or you couldn't tolerate it. Your doctor must have already decided that The Tether™ surgery is the right treatment for you, outside of this study.

There are also some reasons why you wouldn't be able to join. For example, if you have an infection, have had previous spinal surgery at the same level, have very weak bones, or any other serious health condition that would make surgery risky or prevent you from benefiting. If you're pregnant, you also wouldn't be able to take part. It's also important that you're able and willing to attend all the necessary follow-up appointments over the five years of the study.

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.

Have I been diagnosed with a type of progressive idiopathic scoliosis?
Is my spine curve between 30 and 65 degrees?
Are my bones still growing, or am I skeletally immature?
Has bracing not worked for me or was it difficult to tolerate?
Has my doctor already decided The Tether™ surgery is right for me?
Am I able and willing to attend follow-up appointments for 5 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be asked to do anything extra beyond your normal care. First, you'll have an initial visit, followed by your surgery where The Tether™ device will be implanted. After this, you'll need to attend your regular follow-up appointments, which are part of the standard care for this surgery. These appointments will happen at specific times: after you're discharged from the hospital, and then at 6, 12, 24, 36, 48, and 60 months (that's 5 years) after your surgery. During these visits, the study will simply collect information from your medical records and assessments that would be done anyway. The total time you'd be involved in the study by providing information is 5 years after your surgery.

Potential risks and benefits

Taking part in this study doesn't involve any additional medical procedures or changes to your treatment, as it's observing care you're already receiving. The potential benefits are for future patients, as the information gathered helps doctors better understand the safety and usefulness of The Tether™ device. Since you're already having the surgery, the risks are those normally associated with your spinal surgery, not specifically with being in the study. You always have the right to withdraw from the study at any time without it affecting your medical care.

Locations (3)

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

Saint George's Hospital
Verified postcode
London, United Kingdom· Recruiting
Freeman Hospital
Verified postcode
Newcastle upon Tyne, United Kingdom· Recruiting
University Southampton Hospital
Verified postcode
Southampton, United Kingdom· Recruiting

Common questions

What is 'idiopathic scoliosis'?

It's a curve in the spine that develops without a known cause, often in children and teenagers.

What is "The Tether™"?

It's a medical device used during surgery to help correct a curved spine.

Will I get different treatment if I join this study?

No, you will receive the same standard medical care and surgery as planned by your doctor. The study simply collects information from your regular check-ups.

How long will I be involved in the study?

You will be involved for 5 years after your surgery, attending your usual follow-up appointments.

Can I stop participating in the study if I change my mind?

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

How to find out more

Delphine Lebrasseur-Longuet

clinicalemea@highridgemedical.com +33 626262240 Official trial record

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