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

NCT01672749 | Active Not Recruiting DMC

• 1 other identifier: EOS TROLLEY
• Study Type: observational
• Target: 18
• Locations: 2 countries
• Sites: 3

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

Conditions

Early Onset Scoliosis

Keywords

Scoliosis [MESH]; Pediatrics [MESH]; Early onset; Growth guidance; Growing rod; Trolley; Dual growing rod technique

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Sitting height

  10 years

• Standing height

  10 years

• Radiographic measurements

  10 years

• Curve / deformity type characteristics

  10 years

• Adverse Events related to the procedure and/or device under investigation

  10 years

Study Arms (2)

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

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

Interventions

Growth guiding construct using TROLLEY system DEVICE

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

TROLLEY system

Spine based dual growing rod or rib based VEPTR DEVICE

spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America)

Spine based dual growing rod or VEPTR

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (3)

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

Queen's Medical Centre

Nottingham, United Kingdom

Location

Sheffield Children's Hospital

Sheffield, S10 2TH, United Kingdom

Location

Related Publications (1)

• Dayer R, Grevitt M, Breakwell L, Yoon W, Chen M, Ratz T, Szocik T, Zhu YY; Pediatric Spine Study Group (PSSG); Ouellet J. Management of early-onset scoliosis: modern Luque trolley technique led to fewer reoperations within 3 years than other growth-friendly techniques, a prospective cohort study with matched historical controls. Spine Deform. 2025 Sep;13(5):1611-1624. doi: 10.1007/s43390-025-01102-2. Epub 2025 May 28.

  PMID: 40437325 DERIVED

Study Officials

• Jean Ouellet, MD

  McGill University Health Science Centre, Montreal, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 27, 2012
• Study Start: June 1, 2015
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

CH (1); GB (2)