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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2025-02-28

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Early Onset Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Spine based dual growing rod or rib based VEPTR

Intervention Type DEVICE

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.

Growth guiding construct using TROLLEY system

Intervention Type DEVICE

Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs)

Interventions

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Growth guiding construct using TROLLEY system

Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs)

Intervention Type 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)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No