Adolescent Idiopathic Scoliosis
Conditions
Interventions
Nemost Growing Domino, is a CE marked non-fusion, growth enabling device intended to be used with a posterior spinal instrumentation (i.e. E.SPINE®). The system is placed during a minimally invasive s
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: - Diagnosis of idiopathic scoliosis ; - Primary Cobb angle greater than 30°; - Failed non-operative treatment defined as progression of the curve greater than 5° per year at any time; - Skeletally immature (Risser grade* =1 and Skeletal age of hand and wrist X-rays =14y); - In girls, either pre-menarchal or post-menarchal by no more than 1 year; - Age over 7 years; - Non rigid curve; - All Lenke type; - No previous spine surgery.
Exclusion criteria
Exclusion criteria: - Non-idiopathic scoliosis: musculoskeletal or neurologic conditions responsible for cause of the spine curvature (i.e. neuromuscular, congenital or syndromic scoliosis); - History of previous spine surgery; - Risser sign >1; - Disease or deformity likely to affect the stability of the device (i.e. inadequate anatomy of pedicles, trauma or tumor in fixation region, severe osteoporosis, bone destruction or poor bone quality); - Non-reductible scoliosis; - Known allergy or intolerance to one of the device material; - Acute or chronic infections, local or systemic; - Absence or insufficience of covering tissues; - Pathological obesity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Efficacy: No progression of the primary curvature, no fusion, no secondary surgery, while enabling growth. Measured by correction of primary curve Cobb angle at 2 years after skeletal maturity, and T1-S1 length, and instrument segment length. 2.Safety: Treatment related complications as (Serious) Adverse Event rate, reoperation rate, spine arthrodesis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effectiveness (Radiological assessments) a. T1-S1 length, instrumented segment length, available length for growth; b. Coronal balance (primary and secondary curve Cobb angle); c. Sagittal balance (thoracic kyphosis, lumbar lordosis, proximal and distal junctional angle); d. Pelvic parameters (pelvic obliquity, sacral slope, pelvic incidence, pelvic tilt) e. Vertebral rotation based on PA X-Ray 2. Clinical assessments: a. Patient appearance: shoulder imbalance, pelvic imbalance, gibbosity, vertebral rotation (based on scoliometer assesment) b. Patient Reported Outcome (PRO) - SRS-22 (The Scoliosis Research Society’s-22 questionnaire measures multiple domains as pain, self-image, function, and satisfaction with management). | — |
Contacts
Public ContactBJ Van Royen
Amsterdam UMC
Outcome results
None listed