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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Early Onset Scoliosis
• Intervention / Treatment: Device: Spine based dual growing rod or rib based VEPTR; Device: Growth guiding construct using TROLLEY system

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.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Switzerland
  • Genève, Switzerland
    • Hôpitaux universitaires de Genève
• United Kingdom
  • Nottingham, United Kingdom
    • Queen's Medical Centre
  • Sheffield, United Kingdom, S10 2TH
    • Sheffield Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spine based dual growing rod or VEPTR; Patients treated with the TROLLEY system will be compared with patients from the Chest Wall and Spine Deformity Study Group (CWSDSG) and the Growing Spine Study Group (GSSG) treated with a spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America). For each patient in the TROLLEY group a patient from each of the databases will be selected to be matched based on diagnosis, age, gender, and spine deformity classification.	Device: 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)
TROLLEY system; Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs). The TROLLEY system is CE marked at the time of the study conduct.	Device: Growth guiding construct using TROLLEY system; Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sitting height		10 years
Standing height		10 years
Radiographic measurements	Spine length: upper T1 to lower L5 end plates; Chest length: upper T1 to Lower T12; Instrumented spine length	10 years
Curve / deformity type characteristics	Lenke classification; New EOS classification	10 years
Adverse Events related to the procedure and/or device under investigation		10 years
Quality of life	EOS Questionnaire (EOSQ 24); Pediatric version of EQ-5D (EQ-5D-Y)	10 years
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
Growth potential	Chronological age; Bone age (based on radiograph of the hand)	10 years

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Investigators: Principal Investigator: Jean Ouellet, MD, McGill University Health Science Centre, Montreal, Canada

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): February 1, 2023
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: August 22, 2012
• First Submitted That Met QC Criteria: August 24, 2012
• First Posted (Estimated): August 27, 2012

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Scoliosis [MESH]; Pediatrics [MESH]; Early onset; Growth guidance; Growing rod; Trolley; Dual growing rod technique
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: EOS TROLLEY