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Internal Brace

MID-C System for Adolescent Idiopathic Scoliosis

N/A
Recruiting
Research Sponsored by Apifix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has good general health
Appropriate candidate for posterior surgical approach
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I am in good overall health.
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I am a suitable candidate for surgery from the back.
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My scoliosis is classified as Lenke Type 1 or 5.

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

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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Where in the state can participants access this clinical experiment?

"Currently, 21 different clinical sites are recruiting for this study. Some of the cities include Dayton, Stanford and Phoenix; however there are 18 other locations to choose from. It is recommended that participants select the nearest site in order to reduce travel needs."

Answered by AI

Are there open enrollment opportunities in this medical experiment?

"Affirmative. The clinical trial is actively recruiting for participation, as indicated on the entry hosted on clinicaltrials.gov which has been updated most recently on April 28th 2022. 200 patients are needed from 21 different sites to complete this study."

Answered by AI

How many participants have registered to join this research project?

"This research study demands 200 eligible patients. Those wishing to participate can attend one of the several sites, such as Dayton Children's Hospital in Ohio or Lucile Packard Children's Hospital in California."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
< 18
What site did they apply to?
Phoenix Children's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)
2020. "Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04296903.
All > Scoliosis
~87 spots leftby May 2027
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