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MID-C System for Adolescent Idiopathic Scoliosis
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am in good overall health.You do not have any known allergies or sensitivities to titanium.I need treatment for my spinal cord abnormalities.I have a type of scoliosis that is not idiopathic.I have a spine or chest shape issue that affects my upper back.I have an infection or damaged skin where surgery is planned.I am a suitable candidate for surgery from the back.I am not pregnant.I've had spine surgery that may interfere with MID-C system procedures.I do not have any other illnesses that could worsen my health or affect the study results.I have a weakness in my muscles.I do not have active AIDS, HIV, or any ongoing infections.this agrees with Cobb angle measurements
Kyphosis angles measured from T5 to T12 are less than or equal to 55 degrees; this agrees with Cobb angle measurements.My scoliosis is classified as Lenke Type 1 or 5.I have a history of cancer or a current infection.You are generally healthy.
- Group 1: MID-C treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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