Status:
COMPLETED
Limited-efficacy Testing of SDS and NEMOST for Early Onset Neuromuscular Scoliosis
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
EUROS
Conditions:
Neuromuscular Scoliosis
Distraction System
Eligibility:
All Genders
Phase:
NA
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 repea...
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 Nethe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04021784
Start Date
May 6 2019
End Date
March 13 2023
Last Update
June 5 2023
Active Locations (3)
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1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105AZ
2
Erasmus Medical Center
Rotterdam, Netherlands
3
UMC Utrecht
Utrecht, Netherlands, 3584CX