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Internal Brace

MID-C System for Adolescent Idiopathic Scoliosis

N/A
Waitlist Available
Research Sponsored by Apifix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves
Must not have
Spinal cord abnormalities that require treatment
Any type of non-idiopathic scoliosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is for a unidirectional expandable rod to be connected to the spine to treat adolescent idiopathic scoliosis. The rod is designed to act as an internal brace. 200 patients will be enrolled in this study.

Who is the study for?
This trial is for adolescents with a specific type of scoliosis called Adolescent Idiopathic Scoliosis. They should have certain curvature angles in their spine, be in good health, and not allergic to titanium. It's not for those who are pregnant, had previous spine surgery that affects the MID-C system use, have poor bone quality or active infections.
What is being tested?
The study tests the safety and benefit of the MID-C System as an internal brace for scoliosis over five years post-implantation. This device connects to the spine at two points and is meant for patients recently implanted following FDA approval.
What are the potential side effects?
While specific side effects aren't listed here, similar devices may cause pain at the implant site, possible infection risk, potential impact on spinal growth or movement due to being an internal brace.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My scoliosis is classified as Lenke Type 1 or 5.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need treatment for my spinal cord abnormalities.
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I have a type of scoliosis that is not idiopathic.
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I have a spine or chest shape issue that affects my upper back.
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I have an infection or damaged skin where surgery is planned.
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I am not pregnant.
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I've had spine surgery that may interfere with MID-C system procedures.
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I have a weakness in my muscles.
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I do not have active AIDS, HIV, or any ongoing infections.
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I have a history of cancer or a current infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maintenance of major Cobb angle ≤ 40° 5 years post-surgery

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MID-C treatmentExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

ApifixLead Sponsor
6 Previous Clinical Trials
82 Total Patients Enrolled

Media Library

MID-C System (Internal Brace) Clinical Trial Eligibility Overview. Trial Name: NCT04296903 — N/A
Adolescent Idiopathic Scoliosis Research Study Groups: MID-C treatment
Adolescent Idiopathic Scoliosis Clinical Trial 2023: MID-C System Highlights & Side Effects. Trial Name: NCT04296903 — N/A
MID-C System (Internal Brace) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04296903 — N/A
~102 spots leftby Jun 2029
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