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New spinal brace implant tracked for 5 years in teens

NCT ID NCT04296903

Disease control Sponsor: Apifix 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 200 teens with scoliosis who received the MID-C implant, a device that acts like an internal brace to straighten the spine. Researchers will check if the spine stays corrected (curvature under 40 degrees) and monitor for any safety issues over 5 years. The goal is to see if this less invasive option works well long-term.

What this could mean

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

Active substance
MID-C System (internal brace device)
What this could lead to
If successful, this could confirm that the MID-C device is a safe and effective long-term option for treating adolescent scoliosis without major spinal fusion.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less definitive. The device may not maintain correction in all patients, and surgery always carries risks like infection or implant failure.

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

201 people

The number who actually took part.

Started

May 2020

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

10 years and older

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: * Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves; * Cobb angle between 35-60 degrees (inclusive); * Flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray; * Kyphosis angles of ≤ 55 degrees measured from T5 to T12; * Appropriate candidate for posterior surgical approach; * Patient has good general health; * Patient has no known hypersensitivity or allergies to titanium; * Patient's guardian signs a written informed consent form (ICF). Exclusion Criteria: * Any type of non-idiopathic scoliosis; * Any main thoracic deformity that includes vertebral levels and cranial including to T2; * Known history of existing malignancy, or any systemic or local infection; * Spinal cord abnormalities that require treatment; * Known neurological deficit (defined as motor grade \< 5/5); * Known poor bone quality defined as T score -1.5 or less; * For female Patient, pregnancy; * Previous spine surgery that would prevent the successful performance of the MID-C system ; * Active systemic disease, such as AIDS, HIV, or active infection; * Active infection or the skin is compromised at the surgical site; * Systemic disease that would affect the Patient's welfare or overall outcome of the study.

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Conditions

The condition(s) this trial relates to.

adolescent idiopathic scoliosis

As listed by the trial registrant

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

Adolescent idiopathic scoliosis

Contacts and locations

Locations

  • Avera Health

    Sioux Falls, South Dakota, 57105, United States

  • Children's Mercy Hospital

    Kansas City, Kansas, 64108, United States

  • Dayton Children's Hospital

    Dayton, Ohio, 45404, United States

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • Mount Sinai hospital

    New York, New York, 10029, United States

  • Rady Children's Hospital

    San Diego, California, 92123, United States

  • Rainbow babies and children

    Cleveland, Ohio, 44106, United States

  • Riley Children's Health

    Indianapolis, Indiana, 46202, United States

  • Shriners Hospitals for Children

    St Louis, Missouri, 63110, United States

  • Univ. of Mississippi Medical Center (UMMC)

    Jackson, Mississippi, 39216, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Wellstar

    Atlanta, Georgia, 30060, United States

  • Wolfson children's hospital

    Jacksonville, Florida, 32207, United States

  • Women and Children's Hospital - University of Missouri Health Care

    Columbia, Missouri, 65201, United States

More trials for these conditions

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