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Neuromuscular ScoliosisBiPOWRNCT04021784

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

A study testing SDS and NEMOST in people with Neuromuscular Scoliosis and Distraction System, run by UMC Utrecht at 3 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
What is being tested?
SDS and NEMOST
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
3 sitesNetherlands
Study dates
6 May 2019to 13 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • Amsterdam UMC

    Amsterdam, North Holland, 1105AZ

  • Erasmus Medical Center

    Rotterdam

  • UMC Utrecht

    Utrecht, 3584CX

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
SDS, NEMOST

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SDSDevice

    The patient is implanted with SDS.

  • NEMOSTDevice

    The patient is implanted with NEMOST.

Study groups in NCT04021784
Study groupRoleWhat they receive
Spring Distraction System (SDS)ExperimentalThe SDS will be placed and fits around a standard rod of 5.5mm.
Receives: Device: SDS
Necker Enfants Malade OSTeosynthesis (NEMOST)ExperimentalThe NEMOST is a one-way-rod that uses a ratchet type of locking mechanism. Both NEMOST devices should be placed in parallel, on the two fixator rods that are connected with a cross connector
Receives: Device: NEMOST

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Until 1 year post-operatively

  2. 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.

    Measured: Until 1 year post-operatively

Secondary outcomes (12)

  1. 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.

    Measured: Until 1 year post-operatively

  2. 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.

    Measured: Until 1 year post-operatively

  3. 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.

    Measured: Until 1 year post-operatively

  4. 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.

    Measured: Until 1 year post-operatively

  5. SDS vs. NEMOST with respect to surgery time

    Surgery time in minutes

    Measured: Until 1 year post-operatively

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

    Blood loss in cc

    Measured: Until 1 year post-operatively

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

    Length of hospital stay in days

    Measured: Until 1 year post-operatively

  8. SDS vs. NEMOST with respect to recovery time

    Recovery time in minutes

    Measured: Until 1 year post-operatively

  9. 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.

    Measured: Until 1 year post-operatively

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

    Apical Vertebral Rotation based on bone MRI

    Measured: Pre-operatively

  11. 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).

    Measured: Until 1 year post-operatively

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

    Changes in pelvic obliquity on X-rays

    Measured: Until 1 year post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2019
  2. Study start6 May 2019
  3. Primary completion13 Mar 2023
  4. Study completion13 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Half of the patients will be implanted with SDS system, the other half will be implanted with NEMOST.
Masking
Single blind
Who is masked
Participant
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04021784
Sponsor's protocol ID
NL 64018.041.17
Acronym
BiPOWR
Status last verified
Jun 2023
First submitted
13 Jun 2019
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tabeling CS, Blaauw IE, Stempels HW, Schlosser TPC, Ito K, Castelein RM, Kruyt MC, Lemans JVC. Efficacy of the spring distraction system for different etiologies of early onset scoliosis: evaluating an evolving treatment concept. Spine Deform. 2026 Jun 2. doi: 10.1007/s43390-026-01368-0. Online ahead of print.

    PubMed 42228283

  • Lemans JVC, Tabeling CS, Scholten EP, Stempels HW, Miladi L, Castelein RM, Kruyt MC. 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). BMC Musculoskelet Disord. 2023 Jan 10;24(1):20. doi: 10.1186/s12891-022-06048-4.

    PubMed 36627616

Questions about this trial

What is this clinical trial studying?

A study testing SDS and NEMOST in people with Neuromuscular Scoliosis and Distraction System, run by UMC Utrecht at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Limited-efficacy of SDS and NEMOST in terms of curve correction maintenance (time frame: Until 1 year post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04021784, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.

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