Clinical trial NCT02266667: Surgical Treatment of Progressive Scoliosis With "NEMOST" Growing Rod
Official title: Evaluation of the Efficiency of Nemost Growing Spine Device Associated With Physiotherapy in the Surgical Treatment of Progressive Scoliosis of the Child
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Progressive Scoliosis
Keywords: NEMOT device
pediatrics
surgery
progressive scoliosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Company EUROS
First posted: 2014-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the performance of the device "NEMOST" on maintaining of the correction of the scoliosis with growth preservation and avoiding iterative surgeries.

Objective of this study is to evaluate the performance of the growing device "NEMOST" associated to physiotherapy at 12 months postoperatively in patients treated for progressive scoliosis and to evaluate its safety.

Detailed description: A number of scoliosis in the child remain progressive despite conservative treatment well conducted. Nowadays the most used treatment is early surgical treatment by the spinal instrumentation without graft called "growing rods". The use of growing rods in patients with progressive scoliosis requires several repeated surgeries (every 6 to 12 months) in order to follow the growth of children. These repeated surgeries lead to a significant increased risk of complications, that's why many teams around the world have been seeking solutions which allow to obtain a rod expansion without repeated surgery.

The purpose of our study is the evaluation of the use of medical device that will perform the correction of scoliosis and, at the same time, preserve the growth of the child's spine. In addition, the purpose of clinical investigation is to test the theory that distraction effort may be exercised without surgery thanks to traction manoeuvres and physiotherapy. This could allow to obtain in patients with progressive scoliosis, correction of spinal deformity while avoiding many repeated surgeries. Our reference device is growing rod "NEMOST". When implanted, NEMOST rod is immediately turned on, for correcting and maintaining the correction of spinal deformity. After implantation, depending on development in Cobb angle, one or more elongations can be made by sliding the notched portion of the rod in its tunnel by a distraction effort (traction equipments and physiotherapy).

Therefore, the growth device NEMOST will allow to continue, on request, the correction of spinal deformity by performing a distraction by external manoeuvres on the notched part without the need for surgery.

Eligibility criteria: Inclusion Criteria:

* Patient from 5 to 15 years old
* Patient with neuromuscular scoliosis or progressive scoliosis resistant to conservative treatment
* Patient with an indication of first-line surgery without graft
* Patient with low skeletal maturity (Risser test = 0 and triradiate growth cartilages still open)
* Signing of the consent by the holder (s) of parental authority and the investigator
* Affiliated patient to a health service or entitled patient

Exclusion Criteria:

* Patient with a history of spinal surgery
* Patient weighing more than 30 kg and with progressive scoliosis other than neuromuscular
* Patient with contra-indication to Nemost device, that is to say:

  * Inflammation or acute Infection, local or systemic,
  * Allergy or intolerance titanium or polyetheretherketone,
  * Pathology or poor bone quality might compromise the attachment of the device,
  * Nonreducible Scoliosis,
  * Skin Substance insufficient to cover the wound,
  * Pathological Obesity,
  * Fracture and / or spinal tumor,
  * Patient whose behavior presents a risk of failure for the device.

Primary outcomes:
measure: No surgical reoperation
timeFrame: 12 months
measure: No worsening of Cobb angle by more than 15 degrees since the initial correction
timeFrame: 12 months
Secondary outcomes:
measure: Cobb angle
timeFrame: 3 months
measure: Cobb angle
timeFrame: 6 months
measure: Cobb angle (degree)
timeFrame: 18 months
measure: reserve rod (mm)
timeFrame: 3 months
measure: reserve rod (mm)
timeFrame: 6 months
measure: reserve rod (mm)
timeFrame: 12 months
measure: reserve rod (mm)
timeFrame: 18 months
measure: T1-T12 segment and T1-S1 segment
timeFrame: 3 months
measure: T1-T12 segment and T1-S1 segment
timeFrame: 6 months
measure: T1-T12 segment and T1-S1 segment
timeFrame: 12 months
measure: T1-T12 segment and T1-S1 segment
timeFrame: 18 months
measure: respiratory function
timeFrame: 6 months
measure: respiratory function
timeFrame: 12 months
measure: respiratory function
timeFrame: 18 months
measure: Pelvic obliquity (mm)
timeFrame: 3 months
measure: Pelvic obliquity (mm)
timeFrame: 6 months
measure: Pelvic obliquity (mm)
timeFrame: 12 months
measure: Pelvic obliquity (mm)
timeFrame: 18 months
measure: Safety of NEMOST
timeFrame: 3 months
measure: Safety of NEMOST
timeFrame: 6 months
measure: Safety of NEMOST
timeFrame: 12 months
measure: Safety of NEMOST
timeFrame: 18 months
measure: Weight (kg)
timeFrame: Every month for 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Necker Enfants Malades
Study officials:
affiliation: Hospital Necker Enfants Malades
name: Nejib KHOURI, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Miladi L, Khouri N, Pradon J, Elie C, Treluyer JM. One-way self-expanding rod for early-onset scoliosis: early results of a clinical trial of 20 patients. Eur Spine J. 2021 Mar;30(3):749-758. doi: 10.1007/s00586-021-06732-4. Epub 2021 Jan 24.