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Early-Onset Scoliosis Deformity of Spine (Disorder)UniPOWRNCT04003233

Limited-efficacy Testing of Spring Distraction System (SDS) and Unilateral One-way Rod (MID-C) for Early Onset Scoliosis

A study testing SDS and MID-C in people with Early-Onset Scoliosis Deformity of Spine (Disorder) and Idiopathic Scoliosis, run by UMC Utrecht at 2 sites in Netherlands.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The primary aim of this study is to investigate the limited efficacy of these innovative surgical solutions in treatment of Early Onset Scoliosis (EOS) in terms of maintaining reduction while maintaining spinal growth. The secondary aim is to compare both devices for these and other parameters as well as safety. Read more about this study

Who is it for?
Ages 6 to 12 years
What is being tested?
SDS and MID-C
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesNetherlands
Study dates
1 Jul 2019to 1 Dec 2022
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 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Ambulant skeletally immature children, 6-12 yrs. of age, with open triradiate cartilages on X-ray
  • Scoliosis diagnosis prior to the age 10
  • Diagnosis of idiopathic or mild syndromic scoliosis (e.g. 22q11DS, Trisomy 21 or 9, Coffin-Siris)
  • Progressive scoliosis qualified for growth system surgery
  • One curve for treatment with an apex below Th5 and a proximal end vertebra below Th2
  • The primary curve must be between 35 and 75 degrees coronal Cobb angle
  • The primary curve must be non-rigid (i.e. the curve reduces on bending X-rays to <35 degrees or reduces >30% )
  • Normal or hypokyphotic sagittal alignment (Th5 -Th12 < 50 degrees) on lateral X-rays

Who cannot join

  • Patients with an obvious neuromuscular disease
  • Patients that are severely mentally retarded
  • Patients with a scoliosis that extends to the pelvis or the cervicothoracic region
  • Patients with a main curve of more than 8 vertebra Cobb to Cobb
  • Patients with a skeletal dysplasia that effects growth (e.g. achondroplasia, SED)
  • Patients with a systemic disease which severely influences bone quality (e.g. osteogenesis imperfecta, metabolic diseases)
Show all 9Show fewer
  • Patients with soft tissue weakness (e.g. Ehler Danlos, Marfan, Neurofibromatosis, Prader Willi)
  • Patients with an active systemic disease such as Juvenile Idiopathic Arthritis, HIV or oncologic treatment
  • Patients with a previous surgical fusion of the spine

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Amsterdam UMC

    Amsterdam, North Holland, 1105 AZ

  • UMC Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

About this study

The primary aim of this study is to investigate the limited efficacy of these innovative surgical solutions in treatment of Early Onset Scoliosis (EOS) in terms of maintaining reduction while maintaining spinal growth. The secondary aim is to compare both devices for these and other parameters as well as safety.

Read the detailed description

Rationale: EOS is a severe and potentially life-threatening disorder since a disturbance of spinal development leads to impaired development of the trunk, with cardio-respiratory failure as a result, often early in adult life. Several innovative solutions have been developed to treat growing children with severe EOS. The SDS device was developed internally at the dpt. of orthopedics at the UMC Utrecht, the Netherlands, the MID-C device was developed by the company ApiFix Ltd.

Objective: The primary aim of this study is to investigate the limited efficacy of these innovative surgical solutions in treatment of early onset scoliosis in terms of maintaining reduction while maintaining spinal growth. The secondary aim is to compare both devices for these and other parameters as well as safety.

Study design: A feasibility study using two prospective cohorts according to an open label randomized clinical trial (RCT) design. The study will be done in two tertiary referral centers (UMC Utrecht and Amsterdam UMC). Primary endpoints are maintenance of curve correction as well as complications. These data will be compared to a recently described cohort of patients that received a "standard treatment" (Magnetically controlled growing rod (MCGR)). The same endpoints as well as secondary outcomes, will be compared between the two new treatments.

Study population: Children with idiopathic(-like) early onset scoliosis with an indication for a growing rod implant.

Being tested
SDS, MID-C
Keywords
Growth friendly system, Distraction system, Early Onset Scoliosis, Unilateral

What participants receive

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

  • SDSDevice

    The SDS will be added to a traditional growing rod (TGR) of 4.5 or 5.5mm.

  • MID-CDevice

    The MID-C system consists of a unilateral one-way ratchet rod that is connected to the spine with polyaxial connectors

Study groups in NCT04003233
Study groupRoleWhat they receive
Spring Distraction SystemExperimentalThe SDS device will be implanted during a scoliosis correction operation.
Receives: Device: SDS
Minimal Invasive Deformity Correction systemExperimentalThe MID-C device will be implanted during a scoliosis correction operation.
Receives: Device: MID-C

What is being measured

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

  1. Limited-efficacy of SDS and MID-C in terms of curve correction maintenance: changes in cobb angle

    changes in cobb angle on radiographs post-op and at 4 weeks, 3 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-operative FU

  2. Incidence of Treatment-Emergent Serious Adverse Events of SDS and MID-C

    Reported treatment related Serious Adverse Events (SAEs) per-operatively and at 4 weeks, 3 months and 12 months FU.

    Measured: Until 1 year post-operative FU

Secondary outcomes (13)

  1. Limited-efficacy of SDS and MID-C 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 and 12 months FU.

    Measured: Until 1 year post-operative FU

  2. SDS vs. MID-C 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 and 12 months FU. A maximum of 5 degrees increase will be the threshold to define maintenance.

    Measured: Until 1 year post-operative FU

  3. SDS vs. MID-C 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 and 12 months FU.

    Measured: Until 1 year post-operative FU

  4. SDS vs. MID-C with respect to the incidence of Treatment-Emergent Serious Adverse Events

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

    Measured: Until 1 year post-operative FU

  5. SDS vs. MID-C with respect to surgery time

    Surgery time in minutes

    Measured: Until 1 year post-operative FU

  6. SDS vs. MID-C with respect to blood loss during surgery

    blood loss in cc

    Measured: Until 1 year post-operative FU

  7. SDS vs. MID-C with respect to length of hospital stay

    length of hospital stay in days

    Measured: Until 1 year post-operative FU

  8. SDS vs. MID-C with respect to recovery time

    recovery time in minutes

    Measured: Until 1 year post-operative FU

  9. SDS vs. MID-C with respect to bone density

    Bone density changes of the bypassed vertebrae on Dual Energy X-ray Absorptiometry (DEXA)scan post-op and at 3 months en 12 months FU.

    Measured: Until 1 year post-operative FU

  10. SDS vs. MID-C 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 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-operative FU

  11. SDS vs. MID-C with respect to flexibility of the spine

    Flexibility and 3D rotation of the spine on dynamic echography (Scolioscan)

    Measured: Until 1 year post-operative FU

  12. SDS vs. MID-C with respect to 3D development of the spine

    Apical Vertebral Rotation based on MRI

    Measured: Until 1 year post-operative FU

  13. SDS vs. MID-C with respect to patient appearance

    sagittal balance on clinical photographs post-op and at 1 year FU

    Measured: Until 1 year post-operative FU

Timeline

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

  1. First posted1 Jul 2019
  2. Study start1 Jul 2019 (estimated)
  3. Primary completion1 Jul 2022 (estimated)
  4. Study completion1 Dec 2022 (estimated)

Why it stopped: Due to the termination of the collaboration of ApiFix ltd. and the UMC Utrecht

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
Participants will be randomized and assigned to either SDS or MID-C.
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04003233
Sponsor's protocol ID
NL63511.041.17
Acronym
UniPOWR
Status last verified
Mar 2020
First submitted
7 Jun 2019
Last updated
23 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SDS and MID-C in people with Early-Onset Scoliosis Deformity of Spine (Disorder) and Idiopathic Scoliosis, run by UMC Utrecht at 2 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 9 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: withdrawn, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 was withdrawn before enrolling participants, so there are no results.

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 MID-C in terms of curve correction maintenance: changes in cobb angle (time frame: Until 1 year post-operative FU). 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 NCT04003233.

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 23 Mar 2020.

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