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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Paidon Pentelis Hospital
Athens, Greece
RECRUITINGMaintenance of the major curvature ≤ 50 degrees at 24 months
curve progression will be evaluated by X-ray as in the standard of care
Time frame: 24 months
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
Time frame: 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
Time frame: 6 months, 12 months, 24 months
Blood loss during surgery
Data will be collected from the hospital surgery records
Time frame: Baseline - week 0
Duration of surgery
Data will be collected from the hospital surgery records
Time frame: Baseline - week 0
Duration of hospitalisation
Data will be collected from the hospital records
Time frame: Baseline - week 0
Number of reoperations
in case the patient requires a re-operation it will be documented in the study CRF
Time frame: 6 Weeks, 3 months, 6 months, 12 months, 24 months
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