Limited-efficacy Testing of SDS and NEMOST for Early Onset Neuromuscular Scoliosis

Neuromuscular Scoliosis Clinical Trial

— BiPOWR  

Official title:

Limited-efficacy Testing of Spring Distraction System (SDS) and a Bilateral One Way Rod (NEMOST) for Early Onset Neuromuscular Scoliosis (BiPOWR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04021784
• Other study ID #: NL 64018.041.17
• Status: Completed
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: March 13, 2023

Study information

• Verified date: June 2023
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 13, 2023
• Est. primary completion date: March 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Distraction System
• Growth Friendly System
• Neuromuscular Scoliosis
• Scoliosis

Intervention

Device:
• SDS
The patient is implanted with SDS.
• NEMOST
The patient is implanted with NEMOST.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam	Noord-Holland
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	UMC Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	EUROS

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Limited-efficacy of SDS and NEMOST in terms of curve correction maintenance	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.	Until 1 year post-operatively
Primary	Incidence of possible Treatment-Emergent Serious Adverse Events of SDS and NEMOST	Reported treatment related Serious Adverse Events (SAEs) per-operatively and at 4 weeks, 3 months, 6 months and 12 months FU.	Until 1 year post-operatively
Secondary	Limited-efficacy of SDS and NEMOST in terms of spinal length	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.	Until 1 year post-operatively
Secondary	SDS vs. NEMOST with respect to limited-efficacy in terms of curve correction maintenance	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.	Until 1 year post-operatively
Secondary	SDS vs. NEMOST with respect to limited-efficacy in terms of spinal length	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.	Until 1 year post-operatively
Secondary	SDS vs. NEMOST with respect to the development of the sagittale profile and instrumented thoracic kyphosis	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.	Until 1 year post-operatively
Secondary	SDS vs. NEMOST with respect to surgery time	Surgery time in minutes	Until 1 year post-operatively
Secondary	SDS vs. NEMOST with respect to blood loss during surgery	Blood loss in cc	Until 1 year post-operatively
Secondary	SDS vs. NEMOST with respect to length of hospital stay	Length of hospital stay in days	Until 1 year post-operatively
Secondary	SDS vs. NEMOST with respect to recovery time	Recovery time in minutes	Until 1 year post-operatively
Secondary	SDS vs. NEMOST with respect to the incidence of disease- or treatment-related Serious Adverse Events	Reported treatment related SAEs per-operatively and at 4 weeks, 3 months, 6 months and 12 months FU.	Until 1 year post-operatively
Secondary	SDS vs. NEMOST with respect to 3D development of the spine	Apical Vertebral Rotation based on bone MRI	Pre-operatively
Secondary	SDS vs. NEMOST with respect to Quality Of Life (QOL) on the Early Onset Scoliosis Questionnaires (EOSQ-24)	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).	Until 1 year post-operatively
Secondary	SDS vs. NEMOST with respect to the effect on the development of the pelvic obliquity	Changes in pelvic obliquity on X-rays	Until 1 year post-operatively

External Links

•   Surgical treatment of neuromuscular Early Onset Scoliosis with a bilateral posterior one-way rod compared to the Spring Distraction System: study protocol for a limited-efficacy Randomized Controlled Trial (BiPOWR)