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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-06

Study Completion Date

2023-03-13

Brief Summary

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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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Detailed Description

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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.

Conditions

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Neuromuscular Scoliosis Distraction System Growth Friendly System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Half of the patients will be implanted with SDS system, the other half will be implanted with NEMOST.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The patient is blinded to the medical device until after surgery. This is done to prevent selection bias through withdrawal. Patients are unblinded post-operatively, to enable accurate patient counseling with radiographs, on which the implant can be clearly seen.

Study Groups

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Spring Distraction System (SDS)

The SDS will be placed and fits around a standard rod of 5.5mm.

Group Type EXPERIMENTAL

SDS

Intervention Type DEVICE

The patient is implanted with SDS.

Necker Enfants Malade OSTeosynthesis (NEMOST)

The 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

Group Type EXPERIMENTAL

NEMOST

Intervention Type DEVICE

The patient is implanted with NEMOST.

Interventions

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SDS

The patient is implanted with SDS.

Intervention Type DEVICE

NEMOST

The patient is implanted with NEMOST.

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No