Surgical Treatment of Progressive Scoliosis With "NEMOST" Growing Rod

NCT ID: NCT02266667

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-11
• Study Completion Date: 2019-05-15

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.

Conditions

Progressive Scoliosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Progressive scoliosis

Children with progressive scoliosis

Group Type: EXPERIMENTAL

1 NEMOST rod :unilateral vertebral-pelvic implantation

Intervention Type: DEVICE

Implantation of one NEMOST rod (unilateral vertebral-pelvic implantation)

Neuromuscular scoliosis

Children with neuromuscular scoliosis

Group Type: EXPERIMENTAL

2 NEMOST rods : bilateral vertebral-pelvic implantation

Intervention Type: DEVICE

Implantation of two NEMOST rods (bilateral vertebral-pelvic implantation)

Interventions

2 NEMOST rods : bilateral vertebral-pelvic implantation

Implantation of two NEMOST rods (bilateral vertebral-pelvic implantation)

Intervention Type: DEVICE

1 NEMOST rod :unilateral vertebral-pelvic implantation

Implantation of one NEMOST rod (unilateral vertebral-pelvic implantation)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Company EUROS

UNKNOWN

Sponsor Role: collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nejib KHOURI, MD, PhD

Role: STUDY_DIRECTOR

Hospital Necker Enfants Malades

Locations

Hospital Necker Enfants Malades

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 33486593 (View on PubMed)

Other Identifiers

P140301

Identifier Type: -

Identifier Source: org_study_id