imited-efficay testing of spring distraction system (SDS) and a bilateral one way rod (NEMOST) for early onset neuromuscular scoliosis (BiPOWR)

Completed

• Conditions: scoliosis; spine curve; 10023213; 10009720

• Registration Number: NL-OMON50347
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

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

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints are the limited-efficacy in terms of maintenance of curve<br /><br>correction and occurrence of SAEs related to the procedure. </p><br>