MID-C System for Adolescent Idiopathic Scoliosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the MID-C System, a special rod designed to help straighten the spine in teens with adolescent idiopathic scoliosis. The goal is to evaluate how effectively this device functions as an internal brace to correct the spine's curve. Teens diagnosed with this specific type of scoliosis, who have a flexible curve reducible to 30 degrees or less, might be suitable candidates for this study. As an unphased trial, it offers a unique opportunity to enhance understanding of a new treatment option for scoliosis.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the MID-C System is safe for treating adolescent idiopathic scoliosis?
Research has shown that the MID-C System is generally safe for patients with adolescent idiopathic scoliosis. In earlier studies, researchers compared the need for additional surgeries with the MID-C System to other treatments, and it proved to be a good option. The device functions like an internal brace, and results suggest it is well-tolerated. Studies have reported no major safety issues, although some patients might require further procedures after the initial surgery. Overall, the treatment has demonstrated likely benefits and safety for those who have undergone the procedure.12345
Why are researchers excited about this trial?
Unlike the standard of care for adolescent idiopathic scoliosis, which typically involves bracing or surgery, the MID-C System offers a minimally invasive approach. Researchers are excited about this treatment because it potentially allows for spinal correction without the need for large incisions, reducing recovery time and scarring. Additionally, the MID-C System may provide a more flexible and comfortable option for adolescents, which could lead to better compliance and outcomes.
What evidence suggests that the MID-C System is effective for adolescent idiopathic scoliosis?
Research shows that the MID-C System, an internal brace for the spine, could help treat adolescent idiopathic scoliosis. This trial will evaluate the MID-C System's effectiveness. Studies on similar treatments, like the SpineCor System, have shown that flexible bracing can effectively stabilize or correct scoliosis in teenagers. Data indicates that only 4.4% of patients needed to switch to spinal fusion surgery after using the MID-C System, suggesting it successfully manages the condition. This system supports the spine by attaching in a specific way, helping control the curve caused by scoliosis. Overall, early findings are promising for those considering this treatment.36789
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients are implanted with the MID-C System, a unidirectional expandable rod, to treat adolescent idiopathic scoliosis
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a focus on maintaining the major Cobb angle ≤ 40°
What Are the Treatments Tested in This Trial?
Interventions
- MID-C System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Apifix
Lead Sponsor