Clinical trial NCT03330158: Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child
Official title: Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Scoliosis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 5
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this biomedical research is to evaluate the feasibility of the treatment with the new spinal distraction device ASTS in patients aged 4 to 10 years with severe early onset scoliosis.

The hypothesis of this project is that the new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

The ASTS (for Active Scoliosis Treatment System) growing rod is a new fully implantable motorized spinal distraction device which can ensure a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

Detailed description: Despite a better understanding and technical progress, the evolutionary early scoliosis remains a therapeutic challenge. The definition includes idiopathic scoliosis beginning before the age of 3 years, congenital scoliosis, neuromuscular and syndromic. Spinal deformity is often progressive and may compromise cardiorespiratory function.

The goal of treatment is to prevent further avoiding spinal fusion in a subject in growth. Surgery is indicated in case of failure or cons-indication of conservative treatment (corset or plaster). The principle is to position the posterior rods subcutaneous or in muscle attached to two ends of the deformation.

Intraoperative distraction allows correction of the deformity. A new distraction is performed every 6 months until skeletal maturity.

Considerable complication rates are reported (58%), mainly implant infections and disassembly, because of the need for multiple reoperations. Motorized implants can potentially avoid repeated interventions limiting complications.

Thus, the central hypothesis of this project is a new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

Eligibility criteria: Inclusion Criteria:

* Patient 4 to 10 years
* Patient weight between 15kg at 50kg
* Introducing severe scoliosis (Cobb angle\> 40 °) with early onset
* Failed or cons-indication of conservative treatment (cast or brace)
* Agreement of parents or legal guardian (written agreement) and the patient (at least an oral agreement).

Exclusion Criteria:

* Contraindication to surgery
* Age less than 4 years or above 10 years
* Weight less 15kg and above 50 kg

Primary outcomes:
measure: Ability to Implant the device
timeFrame: Day 0: the day of the implantation
measure: Change of the position of the implant
timeFrame: 1 years after the implantation
measure: Change of the position of the implant
timeFrame: 2 years after the implantation
measure: Change of the position of the implant
timeFrame: 3 years after the implantation
measure: Change of the implant's length
timeFrame: 3 months, 6 months, 9 months, 1 year, 2 years and 3 years after the implantation
Secondary outcomes:
measure: Post-surgical pain
timeFrame: 3 months, after the implantation
measure: Post-surgical pain
timeFrame: months after the implantation
measure: Post-surgical pain
timeFrame: 9 months after the implantation
measure: Post-surgical pain
timeFrame: 1 year after the implantation
measure: Survey to evaluate the quality of life
timeFrame: Day 0
measure: Survey to evaluate the quality of life
timeFrame: 6 months after the implantation
measure: Survey to evaluate the quality of life
timeFrame: 1 year after the implantation
measure: to ease for the surgeon to implant the device,
timeFrame: Day 0
measure: wound closure without tension,
timeFrame: Day 0
measure: good positioning of the radiographic implant.
timeFrame: Day 0
measure: Number of medical visits
timeFrame: 1 year
measure: Determine the number of iterative extensions made during follow-up
timeFrame: 1 year
measure: correction of deformation immediately after the operation,
timeFrame: 3 months, 6 months, 9 month and 1 year
measure: correction of deformation immediately after the operation,
timeFrame: 3 months after implantation
measure: Loss correction at 1 year
timeFrame: 6 months after implantation
measure: Loss correction at 1 year
timeFrame: 9 month after implantation
measure: Loss correction at 1 year
timeFrame: 1 year after implantation
measure: Increase the distance T1-S1 at 1 year
timeFrame: 1 year
measure: Effective Elongation measured on radiographs of specification of the device (in mm)
timeFrame: 3 months after implantation
measure: Effective Elongation measured on radiographs of specification of the device
timeFrame: 6 months after implantation
measure: Effective Elongation measured on radiographs of specification of the device
timeFrame: 9 month after implantation
measure: Effective Elongation measured on radiographs of specification of the device
timeFrame: 1 year after implantation
measure: Nature of complications
timeFrame: 1 years
measure: Nature of complications
timeFrame: 2 years
measure: Nature of complications
timeFrame: 3 years
measure: Nature of complications
timeFrame: 5 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Franck Accadbled, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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