Scoliosis, Scoliosis;Congenital, Scoliosis Idiopathic
Conditions
Keywords
Early Onset Scoliosis (EOS)
Brief 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
Interventions
DEVICEMID-C
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.
Sponsors
Apifix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of the major curvature ≤ 50 degrees at 24 months | 24 months | curve progression will be evaluated by X-ray as in the standard of care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| No progression of the primary curve ≥ 10 degrees Cobb angle from correction at time of surgery over time at all follow-up visits | 6 months, 12 months, 24 months | curve progression will be evaluated by X-ray as in the standard of care |
| No progression of the secondary (compensatory) curves ≥ 50 degrees Cobb angle over time at all follow-up visits | 6 months, 12 months, 24 months | curve progression will be evaluated by X-ray as in the standard of care |
| Blood loss during surgery | Baseline - week 0 | Data will be collected from the hospital surgery records |
| Duration of hospitalisation | Baseline - week 0 | Data will be collected from the hospital records |
| Number of reoperations | 6 Weeks, 3 months, 6 months, 12 months, 24 months | in case the patient requires a re-operation it will be documented in the study CRF |
| Duration of surgery | Baseline - week 0 | Data will be collected from the hospital surgery records |
Other
| Measure | Time frame | Description |
|---|---|---|
| Device related serious adverse events | 6 Weeks, 3 months, 6 months, 12 months, 24 months | AE will be monitored routinely |
Countries
Greece
Contacts
Primary ContactDaphna Zaaroor Regev, PhD
Backup ContactUri Arnin
Outcome results
None listed