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

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ClinicalTrials.gov Identifier: NCT01672749
Recruitment Status : Recruiting
First Posted : August 27, 2012
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

August 22, 2012
August 27, 2012
December 18, 2017
June 2015
April 2020   (Final data collection date for primary outcome measure)
Number of re-operations [ Time Frame: 3 years FU ]
Number of re-operations of the spine per patient in both groups after 3 years of FU
Same as current
Complete list of historical versions of study NCT01672749 on ClinicalTrials.gov Archive Site
  • Sitting height [ Time Frame: 10 years ]
  • Standing height [ Time Frame: 10 years ]
  • Radiographic measurements [ Time Frame: 10 years ]
    • 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 ]
    • Lenke classification
    • New EOS classification
  • Adverse Events related to the procedure and/or device under investigation [ Time Frame: 10 years ]
  • Quality of life [ Time Frame: 10 years ]
    • EOS Questionnaire (EOSQ 24)
    • Pediatric version of EQ-5D (EQ-5D-Y)
  • Pulmonary function: [ Time Frame: 10 years ]
    • 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 ]
    • Chronological age
    • Bone age (based on radiograph of the hand)
Same as current
Not Provided
Not Provided
 
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

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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).
Early Onset Scoliosis
  • Device: Growth guiding construct using TROLLEY system
    Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs)
  • 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)
  • 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.
    Intervention: 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.
    Intervention: Device: Growth guiding construct using TROLLEY system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
51
Same as current
April 2027
April 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years to 10 Years   (Child)
No
Contact: Brigitte Gallo +41 44 200 24 06 brigitte.gallo@aofoundation.org
Canada,   Switzerland,   United Kingdom
 
 
NCT01672749
EOS TROLLEY
Yes
Not Provided
Not Provided
AO Clinical Investigation and Documentation
AO Clinical Investigation and Documentation
Not Provided
Principal Investigator: Jean Ouellet, MD McGill University Health Science Centre, Montreal, Canada
AO Clinical Investigation and Documentation
December 2017