Early-Onset Scoliosis Deformity of Spine (Disorder), Idiopathic Scoliosis
Conditions
Keywords
Growth friendly system, Distraction system, Early Onset Scoliosis, Unilateral
Brief summary
The primary aim of this study is to investigate the limited efficacy of these innovative surgical solutions in treatment of Early Onset Scoliosis (EOS) in terms of maintaining reduction while maintaining spinal growth. The secondary aim is to compare both devices for these and other parameters as well as safety.
Detailed description
Rationale: EOS is a severe and potentially life-threatening disorder since a disturbance of spinal development leads to impaired development of the trunk, with cardio-respiratory failure as a result, often early in adult life. Several innovative solutions have been developed to treat growing children with severe EOS. The SDS device was developed internally at the dpt. of orthopedics at the UMC Utrecht, the Netherlands, the MID-C device was developed by the company ApiFix Ltd. Objective: The primary aim of this study is to investigate the limited efficacy of these innovative surgical solutions in treatment of early onset scoliosis in terms of maintaining reduction while maintaining spinal growth. The secondary aim is to compare both devices for these and other parameters as well as safety. Study design: A feasibility study using two prospective cohorts according to an open label randomized clinical trial (RCT) design. The study will be done in two tertiary referral centers (UMC Utrecht and Amsterdam UMC). Primary endpoints are maintenance of curve correction as well as complications. These data will be compared to a recently described cohort of patients that received a standard treatment (Magnetically controlled growing rod (MCGR)). The same endpoints as well as secondary outcomes, will be compared between the two new treatments. Study population: Children with idiopathic(-like) early onset scoliosis with an indication for a growing rod implant.
Interventions
Sponsors
Apifix
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are blinded to the medical device till the surgery. After the surgery participants are able to see which medical device is implanted on X-rays.
Intervention model description
Participants will be randomized and assigned to either SDS or MID-C.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Ambulant skeletally immature children, 6-12 yrs. of age, with open triradiate cartilages on X-ray * Scoliosis diagnosis prior to the age 10 * Diagnosis of idiopathic or mild syndromic scoliosis (e.g. 22q11DS, Trisomy 21 or 9, Coffin-Siris) * Progressive scoliosis qualified for growth system surgery * One curve for treatment with an apex below Th5 and a proximal end vertebra below Th2 * The primary curve must be between 35 and 75 degrees coronal Cobb angle * The primary curve must be non-rigid (i.e. the curve reduces on bending X-rays to \<35 degrees or reduces \>30% ) * Normal or hypokyphotic sagittal alignment (Th5 -Th12 \< 50 degrees) on lateral X-rays
Exclusion criteria
* Patients with an obvious neuromuscular disease * Patients that are severely mentally retarded * Patients with a scoliosis that extends to the pelvis or the cervicothoracic region * Patients with a main curve of more than 8 vertebra Cobb to Cobb * Patients with a skeletal dysplasia that effects growth (e.g. achondroplasia, SED) * Patients with a systemic disease which severely influences bone quality (e.g. osteogenesis imperfecta, metabolic diseases) * Patients with soft tissue weakness (e.g. Ehler Danlos, Marfan, Neurofibromatosis, Prader Willi) * Patients with an active systemic disease such as Juvenile Idiopathic Arthritis, HIV or oncologic treatment * Patients with a previous surgical fusion of the spine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limited-efficacy of SDS and MID-C in terms of curve correction maintenance: changes in cobb angle | Until 1 year post-operative FU | changes in cobb angle on radiographs post-op and at 4 weeks, 3 months and 12 months follow-up (FU). A maximum of 5 degrees increase will be the threshold to define maintenance. |
| Incidence of Treatment-Emergent Serious Adverse Events of SDS and MID-C | Until 1 year post-operative FU | Reported treatment related Serious Adverse Events (SAEs) per-operatively and at 4 weeks, 3 months and 12 months FU. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SDS vs. MID-C with respect to limited-efficacy in terms of spinal length | Until 1 year post-operative FU | Changes in length of T1-T12, T1-S1 and the instrumented segment in mm on calibrated AP X-rays post-op and at 4 weeks, 3 months and 12 months FU. |
| SDS vs. MID-C with respect to the incidence of Treatment-Emergent Serious Adverse Events | Until 1 year post-operative FU | Reported treatment related SAEs per-operatively and at 4 weeks, 3 months and 12 months FU. |
| SDS vs. MID-C with respect to surgery time | Until 1 year post-operative FU | Surgery time in minutes |
| SDS vs. MID-C with respect to blood loss during surgery | Until 1 year post-operative FU | blood loss in cc |
| SDS vs. MID-C with respect to length of hospital stay | Until 1 year post-operative FU | length of hospital stay in days |
| Limited-efficacy of SDS and MID-C in terms of spinal length | Until 1 year post-operative FU | Changes in length of T1-T12, T1-S1 and the instrumented segment in mm on calibrated Anterior Posterior (AP) X-rays post-op and at 4 weeks, 3 months and 12 months FU. |
| SDS vs. MID-C with respect to bone density | Until 1 year post-operative FU | Bone density changes of the bypassed vertebrae on Dual Energy X-ray Absorptiometry (DEXA)scan post-op and at 3 months en 12 months FU. |
| SDS vs. MID-C with respect to Quality Of Life (QOL) on the Early Onset Scoliosis Questionnaires (EOSQ-24) | Until 1 year post-operative FU | Parent reported QOL and performance is assessed with the 24-item Early Onset Scoliosis Questionnaires (EOSQ-24) pre-op and at 4 weeks, 3 months and 12 months FU. EOSQ-24 covers the following domains: Child's Health Related Quality of Life (16 items), Family Impact (2 items) and Satisfaction (2 items). |
| SDS vs. MID-C with respect to flexibility of the spine | Until 1 year post-operative FU | Flexibility and 3D rotation of the spine on dynamic echography (Scolioscan) |
| SDS vs. MID-C with respect to 3D development of the spine | Until 1 year post-operative FU | Apical Vertebral Rotation based on MRI |
| SDS vs. MID-C with respect to patient appearance | Until 1 year post-operative FU | sagittal balance on clinical photographs post-op and at 1 year FU |
| SDS vs. MID-C with respect to recovery time | Until 1 year post-operative FU | recovery time in minutes |
| SDS vs. MID-C with respect to limited-efficacy in terms of curve correction maintenance | Until 1 year post-operative FU | changes in cobb angle on radiographs post-op and at 4 weeks, 3 months and 12 months FU. A maximum of 5 degrees increase will be the threshold to define maintenance. |
Countries
Netherlands
Outcome results
None listed