scoliosis spine curve
Conditions
Interventions
Instead of the *standard treatment* (MCGR) one of the self-growing systems (SDS
or NEMOST) is implanted according a randomized scheme.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: - Niet ambulant - Neuromuscular or syndromal scoliosis - Progressive scoliosis indicated for bipolar fixation extending to the pelvis - Diagnosis of scoliosis before age 10 - Patient under 12 and open triradiate cartilage (usually closes around 12 years for girls and 14 years for boys) - Main curve proximal end vertebra below Th 3 - Non rigid curve (at least 25% decrease on bending X rays) - Patients who have an indication for a primary surgery
Exclusion criteria
Exclusion criteria: - Patients with closed triradiate cartilage - Patients with a skeletal dysplasia that effects growth (Achondroplasia, SED) - Patients with a systemic disease which severely influences bone quality e.g. osteogenesis imperfecta, metabolic diseases - Patients with soft tissue weakness (Ehler Danlos, Marfan, Neurofibromatosis, Prader Willi) - Patients that have a congenital anomaly of the spine of more than 5 vertebrae * - Patients with an active systemic disease such as JIA, HIV, oncologic treatment - Patients with a previous surgical fusion of the spine - Patients that are expected to be lost to FU due to e.g. immigration within 2 years. - Patients that have had a previous spine surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are the limited-efficacy in terms of maintenance of curve correction and occurrence of SAEs related to the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To assess the limited-efficacy in terms of length gain compared to our previous cohort of MGCR patients and literature. 2) The randomised clinical trial design allows comparison of many outcomes between the two systems a) Amount of correction after surgery in terms of Cobb angle b) Maintenance of the cobb angle after reduction c) Spinal growth d) Development of sagittal profile and instrumented thoracic kyphosis. e) Surgical parameters like: surgery time, blood loss, length of hospital stay, recovery time treatment related complications / reoperations f) 3D correction based on (bone) MRI images and Ultrasound (Utrecht only). g) Change in flexibility of the spine based on bending ultrasounds taken before surgery, at 6 weeks and 6 months (UMC Utrecht only) h) Patient overall appearance (shoulder balance and sagittal balance) i) (Parent reported) QOL and performance with the EOS questionnaire j) The effect on pulmonary function. k) Effect on the development of the pelvic incidence (PI) l) Performance in wheelchair m) Postoperative length of the SDS and growth reservoir length of the NEMOST. | — |
Countries
Netherlands
Outcome results
None listed