Clinical trial NCT01672749: Evaluation of a Modern System to Allow for Growth in Children With Scoliosis Versus a Conventional Treatment
Official title: Evaluation of a Growth Guiding Construct vs. Standard Dual Growing Rods and VEPTR for the Treatment of Early Onset Scoliosis Patients: A Prospective Multi-center Cohort Study With a Matched Historical Control
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Early Onset Scoliosis
Keywords: Scoliosis [MESH]
Pediatrics [MESH]
Early onset
Growth guidance
Growing rod
Trolley
Dual growing rod technique
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2012-08-27
Enrollment: 18
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One third of the patients will be recruited in designated investigation sites using the TROLLEY system. For each trolley patient one to two comparative matched pairs will be generated from mining the database of the Chest Wall and Spine Deformity Study Group (CWSDSG) and the Growing Spine Study Group (GSSG).

Brief summary: The foremost challenge when managing early onset scoliosis (curve deformity before the age of 10) is to prevent curve progression while maintaining growth of the spine. Current treatment options require repetitive interventions as the spine and the child grow. This study will compare two techniques of growth modulation: Standard dual growing rods versus the new Luqué Trolley screws

Hypothesis: Patients treated with the DePuy Synthes TROLLEY system will undergo fewer re-operations after 3 years of follow-up (FU) than patients included in the comparison group

Detailed description: The purpose of this clinical study is to show that the growth guiding construct with DePuy Synthes TROLLEY Gliding Vehicles allows for less re-operations and for ongoing spinal growth across an instrumented immature spine while preventing curve progression in early onset scoliosis patients.

Eligibility criteria: Inclusion Criteria:

* Age 5 - 10 years
* Diagnosis of Early Onset Scoliosis with any of the following etiologies:

Idiopathic Congenital Neuromuscular Syndromic Mesenchymal

- Significant growth potential defined by any of the following: pre peek growth velocity bone age \< 10; open triradiate cartilage

* An expected significant spinal deformity of more than 80 degrees at skeletal maturity
* Signed informed consent as legally required (patient, parents, etc.)
* Willingness and ability of the patient to participate in the clinical investigation including imaging and FU procedures
* Willingness and ability of the parents to support the patient in his/her study participation
* Ability of the patient and parents to understand the content of the patient information / informed consent form and participate in the clinical investigation
* Signed informed consent by patient / parent(s)

Exclusion Criteria:

* Curve magnitude and rigidity: Cobb greater than 100 degrees or bends less than 50 degrees
* Prior spinal surgery
* Skeletal maturity
* Any not medically managed severe systemic disease
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Primary outcomes:
measure: Number of re-operations
timeFrame: 3 years FU
Secondary outcomes:
measure: Sitting height
timeFrame: 10 years
measure: Standing height
timeFrame: 10 years
measure: Radiographic measurements
timeFrame: 10 years
measure: Curve / deformity type characteristics
timeFrame: 10 years
measure: Adverse Events related to the procedure and/or device under investigation
timeFrame: 10 years
measure: Quality of life
timeFrame: 10 years
measure: Pulmonary function:
timeFrame: 10 years
measure: Growth potential
timeFrame: 10 years
Other outcomes:
Locations:
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
Study officials:
affiliation: McGill University Health Science Centre, Montreal, Canada
name: Jean Ouellet, MD
role: PRINCIPAL_INVESTIGATOR
References: