Distraction System, Growth Friendly System, Neuromuscular Scoliosis
Conditions
Brief summary
The primary aim of this study is to investigate and describe the limited efficacy of the Spring Distraction System (SDS) and Bilateral One Way Rod (NEMOST) in maintaining curve reduction without repeat lengthening procedures and complications. Secondary aims are to describe growth of the instrumented spine, health-related quality of life, and to compare both devices.
Detailed description
Several innovative solutions have been developed to treat growing children with a severe scoliosis. One device (SDS) was developed internally at the department of orthopaedics UMC Utrecht in the Netherlands. The other device (NEMOST) was developed at the Necker Hospital in France. This study is designed as a multicenter, limited-efficacy study using two prospective cohorts according a randomised clinical trial. The study will be performed in two centers (UMC Utrecht, Amsterdam UMC and Erasmus MC). Primary endpoints are the limited-efficacy in terms of maintenance of curve correction and occurrence of SAEs related to the procedure. These data will be compared to a recently described cohort of patients that received a standard treatment, the MGCR (Skov et al., 2017). Secondary endpoints include spinal- and implant growth, patient performance based on the EOSQ 24 questionnaire and surgical parameters.
Interventions
DEVICESDS
The patient is implanted with SDS.
DEVICENEMOST
The patient is implanted with NEMOST.
Sponsors
EUROS
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The patient is blinded to the medical device until after surgery. This is done to prevent selection bias through withdrawal. Patients are unblinded post-operatively, to enable accurate patient counseling with radiographs, on which the implant can be clearly seen.
Intervention model description
Half of the patients will be implanted with SDS system, the other half will be implanted with NEMOST.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Non 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 * Patients who have an indication for a primary surgery
Exclusion criteria
* Ambulant * 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. likely to immigrate within 1 year. * Patients that have had a previous spine surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limited-efficacy of SDS and NEMOST in terms of curve correction maintenance | Until 1 year post-operatively | Changes in cobb angle on radiographs post-op and at 4 weeks, 3 months, 6 months and 12 months follow-up (FU). A maximum of 5 degrees increase will be the threshold to define maintenance. |
| Incidence of possible Treatment-Emergent Serious Adverse Events of SDS and NEMOST | Until 1 year post-operatively | Reported treatment related Serious Adverse Events (SAEs) per-operatively and at 4 weeks, 3 months, 6 months and 12 months FU. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SDS vs. NEMOST with respect to recovery time | Until 1 year post-operatively | Recovery time in minutes |
| SDS vs. NEMOST with respect to the incidence of disease- or treatment-related Serious Adverse Events | Until 1 year post-operatively | Reported treatment related SAEs per-operatively and at 4 weeks, 3 months, 6 months and 12 months FU. |
| SDS vs. NEMOST with respect to 3D development of the spine | Pre-operatively | Apical Vertebral Rotation based on bone MRI |
| SDS vs. NEMOST with respect to surgery time | Until 1 year post-operatively | Surgery time in minutes |
| Limited-efficacy of SDS and NEMOST in terms of spinal length | Until 1 year post-operatively | 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, 6 months and 12 months FU. |
| SDS vs. NEMOST with respect to blood loss during surgery | Until 1 year post-operatively | Blood loss in cc |
| SDS vs. NEMOST with respect to limited-efficacy in terms of spinal length | Until 1 year post-operatively | 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, 6 months and 12 months FU. |
| SDS vs. NEMOST with respect to the development of the sagittale profile and instrumented thoracic kyphosis | Until 1 year post-operatively | Changes in sagittal profile and thoracic kyphosis and the instrumented (T1 pelvic angle, TPA) segment in mm on calibrated Anterior Posterior (AP) X-rays post-op and at 4 weeks, 3 months, 6 months and 12 months FU. |
| SDS vs. NEMOST with respect to Quality Of Life (QOL) on the Early Onset Scoliosis Questionnaires (EOSQ-24) | Until 1 year post-operatively | 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, 6 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. NEMOST with respect to the effect on the development of the pelvic obliquity | Until 1 year post-operatively | Changes in pelvic obliquity on X-rays |
| SDS vs. NEMOST with respect to limited-efficacy in terms of curve correction maintenance | Until 1 year post-operatively | Changes in cobb angle on radiographs post-op and at 4 weeks, 3 months, 6 months and 12 months follow-up (FU). A maximum of 5 degrees increase will be the threshold to define maintenance. |
| SDS vs. NEMOST with respect to length of hospital stay | Until 1 year post-operatively | Length of hospital stay in days |
Countries
Netherlands
Outcome results
None listed