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

ApiFix

Status: Unknown

Conditions: Scoliosis; Scoliosis;Congenital; Scoliosis Idiopathic

Treatments: Device: MID-C

Study type: Interventional

Funder types: Industry

Identifiers

NCT03519321

AF-MID-C-EOS 01-16

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with EOS aged 6-11 years, including idiopathic, syndromic, congenital and low tone neuromuscular diagnoses.
2. Standing x-ray: a single major curve ≤ 8 vertebral segments, 35 to 75 degrees Cobb angle
3. "Normal" or hypokyphotic sagittal contour (T5-T12 ≤ 50⁰ degrees)
4. 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
5. Patients with ≤ 25 degrees trunk rotation based on Scoliometer measurement
6. Subject in good general health
7. Subject and both subject's guardians/legal representatives are willing to sign a written informed consent form

Exclusion criteria

1. EOS with more than one structural curve or a single curve involving more than 8 segments
2. High tone neuromuscular diagnoses
3. Primary curve cobb angle > 75 degrees
4. Kyphosis > 50 degrees
5. Previous scoliosis surgery
6. Neural axis abnormality observed by an MRI scan
7. Known allergy to titanium
8. Active systemic disease, such as AIDS, HIV, or active infection
9. Systemic disease that would affect the subject's welfare or overall outcome of the study.
10. Severely mentally compromised

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Treatment

Experimental group

Description:

MID-C EOS implant will be implanted for the correction of the spine deformity in children found eligible for the study

Treatment:

Device: MID-C