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Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals (MCGR)

P

Pediatric Spine Foundation

Status

Active, not recruiting

Conditions

Early-Onset Scoliosis Deformity of Spine

Treatments

Device: MAGEC® Spinal Bracing And Distraction System

Study type

Interventional

Funder types

Other

Identifiers

NCT04058561
PSSG0038

Details and patient eligibility

About

A hospital-based cluster stratified randomization control study will be conducted to investigate spinal growth in Early Onset Scoliosis patients between 5 and 9 years of age. Patients must have a major coronal curve measuring over 50 degrees and be undergoing Magnetically Controlled Growing Rod treatment. We will be studying 6-week lengthening intervals compared to 16-week lengthening intervals on spinal growth within 3 years.

Full description

The Magnetically Controlled Growing Rod (MCGR) system consists of growing rods similarly implanted as with traditional approaches, but with subsequent noninvasive distractions. The implanted growing rods are magnetically controlled and adjusted outside the body using an external remote controller (ERC) following initial surgical insertion. No incision or anesthesia are used for rod lengthening procedures and they are performed by the surgeon in an outpatient or office setting. The purpose of this study is to determine the effect of a 6-week lengthening interval compared to a 16-week lengthening interval on spinal growth in Early Onset Scoliosis patients between 5 and 9 years of age with a major coronal curve over 50 degrees undergoing MCGR treatment within 3 years.

Enrollment

210 estimated patients

Sex

All

Ages

5 to 9 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients with diagnosis of Early Onset Scoliosis (scoliosis before age 10)
  • Between 5 and 9 years of age (5.0 to 9.9 years)
  • Major curve greater than 50 degrees at time of index surgery
  • Dual-rod Magnetically Controlled Growing Rod implantation only
  • Spine or rib-based constructs
  • Pre-operative and intra-operative halo gravity traction is allowed

Exclusion criteria

  • Patients with previous spine surgery, including other growth friendly techniques
  • Patients who cannot abide by the study requirements due to geographical or other similar constraints

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

210 participants in 2 patient groups

6 weeks
Experimental group
Description:
6-week lengthening interval
Treatment:
Device: MAGEC® Spinal Bracing And Distraction System
16 weeks
Active Comparator group
Description:
16-week lengthening interval
Treatment:
Device: MAGEC® Spinal Bracing And Distraction System

Trial contacts and locations

20

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Central trial contact

Regina Woon; Tricia St. Hilaire

Data sourced from clinicaltrials.gov

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