Surgical Treatment of Progressive Scoliosis With "NEMOST" Growing Rod

Progressive Scoliosis Clinical Trial

— NEMOST  

Official title:

Evaluation of the Efficiency of Nemost Growing Spine Device Associated With Physiotherapy in the Surgical Treatment of Progressive Scoliosis of the Child

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266667
• Other study ID #: P140301
• Status: Completed
• Phase: N/A
• Start date: April 11, 2016
• Est. completion date: May 15, 2019

Study information

• Verified date: January 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 15, 2019
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Progressive Scoliosis
• Scoliosis

Intervention

Device:
• 2 NEMOST rods : bilateral vertebral-pelvic implantation
Implantation of two NEMOST rods (bilateral vertebral-pelvic implantation)
• 1 NEMOST rod :unilateral vertebral-pelvic implantation
Implantation of one NEMOST rod (unilateral vertebral-pelvic implantation)

Locations

Country	Name	City	State
France	Hospital Necker Enfants Malades	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Company EUROS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No surgical reoperation	The lack of indication of surgical reoperations means that the correction of scoliosis is satisfactory and the growth had been maintained	12 months
Primary	No worsening of Cobb angle by more than 15 degrees since the initial correction	A worsening of the Cobb angle by more than 15 ° since the initial correction is considered an indication of reoperation	12 months
Secondary	Cobb angle	Radiographic measure : less than 15 degrees since the initial correction	3 months
Secondary	Cobb angle	Radiographic measure : less than 15 degrees since the initial correction	6 months
Secondary	Cobb angle (degree)	Radiographic measure : less than 15 degrees since the initial correction	18 months
Secondary	reserve rod (mm)	This amount reflects the actual elongation of the device	3 months
Secondary	reserve rod (mm)	This amount reflects the actual elongation of the device	6 months
Secondary	reserve rod (mm)	This amount reflects the actual elongation of the device	12 months
Secondary	reserve rod (mm)	This amount reflects the actual elongation of the device	18 months
Secondary	T1-T12 segment and T1-S1 segment	which reflect the real growth of the spine	3 months
Secondary	T1-T12 segment and T1-S1 segment	which reflect the real growth of the spine	6 months
Secondary	T1-T12 segment and T1-S1 segment	which reflect the real growth of the spine	12 months
Secondary	T1-T12 segment and T1-S1 segment	which reflect the real growth of the spine	18 months
Secondary	respiratory function	Translated chest and lung growth, as well as the actual improvement of respiratory function	6 months
Secondary	respiratory function	Translated chest and lung growth, as well as the actual improvement of respiratory function	12 months
Secondary	respiratory function	Translated chest and lung growth, as well as the actual improvement of respiratory function	18 months
Secondary	Pelvic obliquity (mm)	translated improving the overall balance of the trunk of the patient for the group of children with neuromuscular scoliosis	3 months
Secondary	Pelvic obliquity (mm)	translated improving the overall balance of the trunk of the patient for the group of children with neuromuscular scoliosis	6 months
Secondary	Pelvic obliquity (mm)	translated improving the overall balance of the trunk of the patient for the group of children with neuromuscular scoliosis	12 months
Secondary	Pelvic obliquity (mm)	translated improving the overall balance of the trunk of the patient for the group of children with neuromuscular scoliosis	18 months
Secondary	Safety of NEMOST	Nature-incidence and severity of complications due to NEMOST : infections, elongation failure, problems with healing after surgery, neurological deficit) Nature and incidence of any medical and surgical intervention in relation to device NEMOST	3 months
Secondary	Safety of NEMOST	Nature-incidence and severity of complications due to NEMOST : infections, elongation failure, problems with healing after surgery, neurological deficit) Nature and incidence of any medical and surgical intervention in relation to device NEMOST	6 months
Secondary	Safety of NEMOST	Nature-incidence and severity of complications due to NEMOST : infections, elongation failure, problems with healing after surgery, neurological deficit) Nature and incidence of any medical and surgical intervention in relation to device NEMOST	12 months
Secondary	Safety of NEMOST	Nature-incidence and severity of complications due to NEMOST : infections, elongation failure, problems with healing after surgery, neurological deficit) Nature and incidence of any medical and surgical intervention in relation to device NEMOST	18 months
Secondary	Weight (kg)	Reflecting the improvement in the general and trophic status of the patient	Every month for 18 months