MID-C System for Adolescent Idiopathic Scoliosis

Recruiting at 19 trial locations

Overseen By Adi Toister

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Apifix

Disqualifiers: Non-idiopathic scoliosis, Malignancy, Neurological deficit, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Implantation procedure

200 Participants Needed

Trial Summary

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 data supports the effectiveness of the MID-C System treatment for adolescent idiopathic scoliosis?

The research on similar treatments, like the SpineCor System, shows that dynamic bracing can effectively stabilize or correct scoliosis in adolescents, with 74.2% of patients achieving successful outcomes. This suggests that treatments designed to progressively correct spinal curvature, like the MID-C System, may also be effective. ^{1 2 3 4 5}

Is the MID-C System safe for humans?

The MID-C System, evaluated as a titanium clip-screw implant for adolescent idiopathic scoliosis, was part of a two-year safety study, indicating it has been tested for safety in humans. ^{3 6 7 8 9}

How is the MID-C System treatment different from other treatments for adolescent idiopathic scoliosis?

The MID-C System is unique because it is a novel instrumentation device specifically designed for correcting spinal deformities in adolescent idiopathic scoliosis, potentially offering a new approach compared to traditional methods like bracing or surgery. ^{1 9 10 11 12}

What is the purpose of this trial?

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 scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. The MID-C System is designed to act as an internal brace. Patients implanted with the device in the US within 2 years of FDA's approval of H17001 should be enrolled in the study. A minimum number of 200 patients will be enrolled in this study.

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: MID-C treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Apifix

Lead Sponsor

Trials

7

Recruited

280+

References

1. England pubmed.ncbi.nlm.nih.gov

Use of the Universal Clamp for deformity correction and as an adjunct to fusion: preliminary results in scoliosis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Changes in surface and radiographic deformity after Universal Spine System for right thoracic adolescent idiopathic scoliosis: is rib-hump reassertion a mechanical problem of the thoracic cage rather than an effect of relative anterior spinal overgrowth? [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of early adolescent idiopathic scoliosis using the SpineCor System. [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Quality of life in adolescent patients with idiopathic scoliosis after brace treatment: A meta-analysis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of preoperative brace treatment on quality of life in adolescents with idiopathic scoliosis following corrective surgery. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Spine Growth Modulation in Early Adolescent Idiopathic Scoliosis: Two-Year Results of Prospective US FDA IDE Pilot Clinical Safety Study of Titanium Clip-Screw Implant. [2021]

7. England pubmed.ncbi.nlm.nih.gov

What Factors Are Associated With Kyphosis Restoration in Lordotic Adolescent Idiopathic Scoliosis Patients? [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Rib-based Distraction Device Implantation Before Age 3 Associated With Higher Unplanned Rate of Return to the Operating Room. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A porcine model for progressive thoracic scoliosis. [2009]

10. United States pubmed.ncbi.nlm.nih.gov

Characterization and Predictive Value of Segmental Curve Flexibility in Adolescent Idiopathic Scoliosis Patients. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A scoping review of the different types of exercise programs proposed for the improvement of postural balance in adolescents with idiopathic scoliosis. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Special Issue: "Spinal Deformity: Diagnosis, Complication and Treatment in Adolescent Patients". [2023]