Evaluation of a Modern System to Allow for Growth in Children With Scoliosis Versus a Conventional Treatment

Early Onset Scoliosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01672749
• Other study ID #: EOS TROLLEY
• Status: Active, not recruiting
• Start date: June 2015
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: February 2025
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Onset Scoliosis
• Scoliosis

Intervention

Device:
• Growth guiding construct using TROLLEY system
Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs)
• Spine based dual growing rod or rib based VEPTR
spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America)

Locations

Country	Name	City	State
Switzerland	Hôpitaux Universitaires de Genève	Genève
United Kingdom	Queen's Medical Centre	Nottingham
United Kingdom	Sheffield Children's Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
AO Innovation Translation Center

Countries where clinical trial is conducted

Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of re-operations	Number of re-operations of the spine per patient in both groups after 3 years of FU	3 years FU
Secondary	Sitting height		10 years
Secondary	Standing height		10 years
Secondary	Radiographic measurements	Spine length: upper T1 to lower L5 end plates; Chest length: upper T1 to Lower T12; Instrumented spine length	10 years
Secondary	Curve / deformity type characteristics	Lenke classification; New EOS classification	10 years
Secondary	Adverse Events related to the procedure and/or device under investigation		10 years
Secondary	Quality of life	EOS Questionnaire (EOSQ 24); Pediatric version of EQ-5D (EQ-5D-Y)	10 years
Secondary	Pulmonary function:	Forced vital capacity (FVC), actual [L] and predicted [%]; Forced expiratory volume in 1 second (FEV1), actual [L] and predicted [%]; Total lung capacity (TLC), actual [L] and predicted [%]; Use and rate of assisted ventilation; Residual volume (RV)	10 years
Secondary	Growth potential	Chronological age; Bone age (based on radiograph of the hand)	10 years