Minimal Invasive Deformity Correction (MID-C) System for Early Onset Scoliosis

Study Overview
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Brief Summary
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Early Onset Scoliosis (EOS) is defined as scoliosis with onset under the age of ten years, regardless of etiology. It is a complex three-dimensional deformity of the spine which can cause significant physical and psychological problems. Currently there are two basic treatment options available for EOS: non-surgical and surgical. ApiFix Ltd. has developed a novel growing rod system for surgical treatment of EOS, the MID-C system. It is indicated for patients with a scoliosis of 35 to 75 degrees Cobb angle

Official Title
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Safety and Effectiveness Evaluation of the Minimal Invasive Deformity Correction (MID-C) System in Early Onset Scoliosis

Conditions
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Scoliosis, Scoliosis Idiopathic, Scoliosis;Congenital

Intervention / Treatment
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* Device: MID-C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with EOS aged 6-11 years, including idiopathic, syndromic, congenital and low tone neuromuscular diagnoses. Standing x-ray: a single major curve ≤ 8 vertebral segments, 35 to 75 degrees Cobb angle Normal or hypokyphotic sagittal contour (T5-T12 ≤ 50⁰ degrees) Primary curve should be reduced to < 35 degrees Cobb angle on lateral bending/traction/stretch x-ray- the residual rigid segment must be ≤ 35 degrees Patients with ≤ 25 degrees trunk rotation based on Scoliometer measurement Subject in good general health Subject and both subject's guardians/legal representatives are willing to sign a written informed consent form Exclusion Criteria: EOS with more than one structural curve or a single curve involving more than 8 segments High tone neuromuscular diagnoses Primary curve cobb angle > 75 degrees Kyphosis > 50 degrees Previous scoliosis surgery Neural axis abnormality observed by an MRI scan Known allergy to titanium Active systemic disease, such as AIDS, HIV, or active infection Systemic disease that would affect the subject's welfare or overall outcome of the study. Severely mentally compromised

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>MID-C EOS implant will be implanted for the correction of the spine deformity in children found eligible for the study | Device: MID-C<br>* The MID-C system is being connected to the spine via standard unilateral posterior approach. Pedicle screws above and below the main curve are being used to attach the device to the selected vertebra.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of the major curvature ≤ 50 degrees at 24 months | curve progression will be evaluated by X-ray as in the standard of care | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No progression of the primary curve ≥ 10 degrees Cobb angle from correction at time of surgery over time at all follow-up visits | curve progression will be evaluated by X-ray as in the standard of care | 6 months, 12 months, 24 months | 
| No progression of the secondary (compensatory) curves ≥ 50 degrees Cobb angle over time at all follow-up visits | curve progression will be evaluated by X-ray as in the standard of care | 6 months, 12 months, 24 months | 
| Blood loss during surgery | Data will be collected from the hospital surgery records | Baseline - week 0 | 
| Duration of surgery | Data will be collected from the hospital surgery records | Baseline - week 0 | 
| Duration of hospitalisation | Data will be collected from the hospital records | Baseline - week 0 | 
| Number of reoperations | in case the patient requires a re-operation it will be documented in the study CRF | 6 Weeks, 3 months, 6 months, 12 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Onset Scoliosis (EOS)