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New tethering technique may offer Motion-Sparing alternative to spinal fusion for kids with scoliosis

NCT ID NCT03506334

Disease control Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests a device called the Zimmer Biomet Tether System, which is surgically placed along the spine to correct curvature in children with scoliosis. Unlike traditional spinal fusion, which permanently joins vertebrae, this tethering approach aims to guide growth while preserving flexibility. The trial compares safety and curve correction in children aged 10–16 with moderate to severe curves (40–70 degrees) who still have growth remaining.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Zimmer Biomet Tether System and Dynesys System components
What this could lead to
If successful, this tethering approach could offer a less rigid alternative to spinal fusion, preserving more motion in growing children with scoliosis.
What could go wrong
This is a small pilot study, so results may not apply broadly. Risks include curve progression, need for revision surgery, and device-related complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2018

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 16 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male \& female, age 10 years to 16 years. 2. Scoliosis curve between 40-70 degrees. 3. At least 1 year of growth remaining measured by Sanders bone age 4 or less or Risser stage 2 or less. 4. Adolescent idiopathic scoliosis. 5. Lenke 1, 2, 3C, 5 (thoracic, thoracolumbar, or thoracic and lumbar). 6. Parents must be able to understand the study and sign the consent document. Assent will be obtained and documented as age appropriate. 7. Patients and parents must be able to comply with study procedures and visits, including 3-month, 1-year, and 2-year follow-up visits. Exclusion Criteria: 1. Congenital, neuromuscular or syndromic scoliosis. 2. Underlying neuromuscular disease. 3. Pregnancy. 4. Nonflexible curves (bending films show residual curve greater than 40 degrees). 5. Prior surgery for scoliosis treatment. 6. Patients with active systemic infection. 7. Known, reported allergies to titanium, PET, or PCU. Known, reported substance abuse, including alcohol.

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Conditions

The condition(s) this trial relates to.

adolescent idiopathic scoliosis scoliosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Scoliosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

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