MID-C System for Adolescent Idiopathic Scoliosis

Not currently recruiting at 20 trial locations
PM
DZ
AT
Overseen ByAdi Toister
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Apifix
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I am in good overall health.
Patient's guardian signs a written informed consent form (ICF)
You do not have any known allergies or sensitivities to titanium.
See 7 more

Exclusion Criteria

Known poor bone quality defined as T score -1.5 or less
I need treatment for my spinal cord abnormalities.
I have a type of scoliosis that is not idiopathic.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients are implanted with the MID-C System, a unidirectional expandable rod, to treat adolescent idiopathic scoliosis

Implantation procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on maintaining the major Cobb angle ≤ 40°

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • MID-C System
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: MID-C treatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Apifix

Lead Sponsor

Trials
7
Recruited
280+

Citations

PMS Evaluation of Safety and Efficacy of the MID-C System ...The ApiFix MID-C System is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a ...
MID-C System for Adolescent Idiopathic ScoliosisThe research on similar treatments, like the SpineCor System, shows that dynamic bracing can effectively stabilize or correct scoliosis in adolescents, with ...
MID-C SYSTEM PATIENT GUIDEAdditionally, the data reports a 4.4% (11 out of 252 patients) rate of conversion to spinal fusion at some point after receiving the MID-C System, which ...
Adolescent idiopathic scoliosis: indications for bracing and ...Results published in 1993 demonstrated that brace treatment is effective compared to natural history (6). In another study (3), the records and radiographs of ...
Scoliosis Clinical TrialsThe purpose of this study is to evaluate the continued safety and probable benefit of the MID-C system for 5 years post-implantation in Adolescent Idiopathic ...
Minimally Invasive Deformity Correction (MID-C) System ...A clinical study was performed to support the safety and probable benefit of the Minimally. Invasive Deformity Correction System for subjects with adolescent ...
Summary of Safety and Probable Benefit (SSPB)In regard to safety, reoperation rates reported for the MID-C System were compared to literature describing the 24-month and 60-month ...
NCT03071445 | Feasibility Study of MID-C for AISThis study is designed to demonstrate that the MID-C System is safe and effective. ... (MID-C) System in Adolescent Idiopathic Scoliosis (AIS). Conditions.
Indications for UseThe ApiFix® MID-C System is indicated for treatment of adolescent idiopathic scoliosis ... The safety of the MID-C System in the MR environment is unknown.
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