Minimal Invasive Deformity Correction (MID-C) System for Early Onset Scoliosis (NCT03519321) | Clinical Trial Compass
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Minimal Invasive Deformity Correction (MID-C) System for Early Onset Scoliosis
Greece60 participantsStarted 2018-04-11
Plain-language summary
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
Who can participate
Age range6 Years – 11 Years
SexALL
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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
What they're measuring
1
Maintenance of the major curvature ≤ 50 degrees at 24 months