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Completed

NCT Number: NCT04021784

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

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.

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Key information

Conditions

Neuromuscular Scoliosis Distraction System Growth Friendly System

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, Amsterdam, North Holland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SDS

Device

The patient is implanted with SDS.

NEMOST

Device

The patient is implanted with NEMOST.

Primary outcomes

  1. Limited-efficacy of SDS and NEMOST in terms of curve correction maintenance

    Time frame: 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.

  2. Incidence of possible Treatment-Emergent Serious Adverse Events of SDS and NEMOST

    Time frame: 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 outcomes

  1. Limited-efficacy of SDS and NEMOST in terms of spinal length

    Time frame: 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.

  2. SDS vs. NEMOST with respect to limited-efficacy in terms of curve correction maintenance

    Time frame: 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.

  3. SDS vs. NEMOST with respect to limited-efficacy in terms of spinal length

    Time frame: 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.

  4. SDS vs. NEMOST with respect to the development of the sagittale profile and instrumented thoracic kyphosis

    Time frame: 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.

  5. SDS vs. NEMOST with respect to surgery time

    Time frame: Until 1 year post-operatively

    Surgery time in minutes

  6. SDS vs. NEMOST with respect to blood loss during surgery

    Time frame: Until 1 year post-operatively

    Blood loss in cc

  7. SDS vs. NEMOST with respect to length of hospital stay

    Time frame: Until 1 year post-operatively

    Length of hospital stay in days

  8. SDS vs. NEMOST with respect to recovery time

    Time frame: Until 1 year post-operatively

    Recovery time in minutes

  9. SDS vs. NEMOST with respect to the incidence of disease- or treatment-related Serious Adverse Events

    Time frame: Until 1 year post-operatively

    Reported treatment related SAEs per-operatively and at 4 weeks, 3 months, 6 months and 12 months FU.

  10. SDS vs. NEMOST with respect to 3D development of the spine

    Time frame: Pre-operatively

    Apical Vertebral Rotation based on bone MRI

  11. SDS vs. NEMOST with respect to Quality Of Life (QOL) on the Early Onset Scoliosis Questionnaires (EOSQ-24)

    Time frame: 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).

  12. SDS vs. NEMOST with respect to the effect on the development of the pelvic obliquity

    Time frame: Until 1 year post-operatively

    Changes in pelvic obliquity on X-rays

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • EUROS

Registry information

Official study title

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

Acronym: BiPOWR

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 16, 2019
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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