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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by AO Clinical Investigation and Documentation
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01672749
First received: August 22, 2012
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Early Onset Scoliosis (EOS)
Device: Growth guiding construct using TROLLEY system
Device: Spine based dual growing rod or rib based VEPTR

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Number of re-operations [ Time Frame: 3 years FU ] [ Designated as safety issue: No ]
    Number of re-operations of the spine per patient in both groups after 3 years of FU


Secondary Outcome Measures:
  • Sitting height [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Standing height [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Radiographic measurements [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    • Spine length: upper T1 to lower L5 end plates
    • Chest length: upper T1 to Lower T12
    • Instrumented spine length

  • Curve / deformity type characteristics [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    • Lenke classification
    • New EOS classification

  • Adverse Events related to the procedure and/or device under investigation [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    • EOS Questionnaire (EOSQ 24)
    • Pediatric version of EQ-5D (EQ-5D-Y)

  • Pulmonary function: [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    • 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)

  • Growth potential [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    • Chronological age
    • Bone age (based on radiograph of the hand)


Estimated Enrollment: 51
Study Start Date: September 2015
Estimated Study Completion Date: July 2026
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

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

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
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).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672749

Contacts
Contact: Denise Schmid +41 44 200 24 77 denise.schmid@aofoundation.org
Contact: Marina Kueng +41 81 414 25 05

Locations
Canada
McGill University Health Science Centre - Montreal Children Hospital Not yet recruiting
Montreal, Canada, 2300
Principal Investigator: Jean Ouellet, MD, FRCSC         
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Principal Investigator: Jean Ouellet, MD McGill University Health Science Centre, Montreal, Canada
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01672749     History of Changes
Other Study ID Numbers: EOS TROLLEY
Study First Received: August 22, 2012
Last Updated: July 30, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by AO Clinical Investigation and Documentation:
Scoliosis [MESH]
Pediatrics [MESH]
Early onset
Growth guidance
Growing rod
Trolley
Dual growing rod technique

Additional relevant MeSH terms:
Scoliosis
Bone Diseases
Musculoskeletal Diseases
Spinal Curvatures
Spinal Diseases

ClinicalTrials.gov processed this record on October 22, 2014