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The Tether™ - Vertebral Body Tethering System Post Approval Study

Study on Tether™ Spine System after approval.

Recruiting
All
Phase N/A

The Tether™ - Vertebral Body Tethering System study is looking at a way to help people with idiopathic scoliosis, which is when the spine curves sideways without a known cause. Instead of the usual surgery called spinal fusion, this study focuses on a different technique called Anterior Vertebral Body Tethering (AVBT). AVBT helps straighten the spine using screws and a strong cord, and it allows the spine to grow more naturally. This study will see how safe and helpful this method is over time.

Who can join? Children with scoliosis that is getting worse, who are still growing, and have a spine curve between 30° and 65° are eligible. They should have tried braces but they didn't work for them. People with infections, previous spine surgeries, or certain health problems cannot join. Participants need to come back for check-ups.

  • Study Duration: Long-term follow-up is needed.
  • Visits Needed: Participants must be able to return for follow-up visits.
  • Risks: Possible complications related to surgery and post-operative care.
Study details
    Scoliosis Idiopathic

NCT04505579

ZimVie

13 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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