Anterior Vertebral Body Tethering for Adolescent Idiopathic Scoliosis

Ochsner Health System- Jefferson Hwy, New Orleans, LA
Adolescent Idiopathic Scoliosis+7 More ConditionsAnterior Vertebral Body Tethering - Device
Eligibility
8 - 16
All Sexes

Study Summary

This trial will test if a new treatment for scoliosis, called vertebral body tethering, is safe and effective.

Eligible Conditions
  • Adolescent Idiopathic Scoliosis
  • Scoliosis
  • Osteopathy
  • Juvenile Scoliosis
  • Spinal Diseases
  • Musculoskeletal Disorders

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 2 years after last subject's device implantation

Year 2
Efficacy: Comparison of Preoperative and Postoperative Cobb Angle
Feasibility: Incidence of Successfully Implanted Tether Devices
Safety: Incidence of Treatment-Emergent Adverse Events

Trial Safety

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Anterior Vertebral Body Tethering
1 of 1

Experimental Treatment

2 Total Participants · 1 Treatment Group

Primary Treatment: Anterior Vertebral Body Tethering · No Placebo Group · N/A

Anterior Vertebral Body Tethering
Device
Experimental Group · 1 Intervention: Anterior Vertebral Body Tethering · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years after last subject's device implantation

Who is running the clinical trial?

Ochsner Health SystemLead Sponsor
91 Previous Clinical Trials
184,874 Total Patients Enrolled
Lawrence HaberLead Sponsor
Lawrence Haber, MD5.04 ReviewsPrincipal Investigator - Ochsner Health System
Ochsner Health System
1 Previous Clinical Trials
95 Total Patients Enrolled
5Patient Review
They're an excellent communicator and great at speaking to both parents and children. I would recommend them without reservation.

Eligibility Criteria

Age 8 - 16 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
It's okay if you have spina bifida occulta.
You have been diagnosed with a type of spinal curvature called idiopathic scoliosis.
Your spine curves at an angle between 35 and 60 degrees from the middle of your back to your lower back.
You have a certain type of spinal curvature, as determined by your doctor, which is classified as Lenke 1, 2, 3, 5, or 6.
References

Frequently Asked Questions

What criteria must a participant meet to be eligible for inclusion in this trial?

"This study seeks 40 children aged 8 to 16 with scoliosis. Preliminary requirements include: Sanders bone age ≤4; presence of Spina bifida occulta permitted; thoracic or thoracolumbar/lumbar curves ≥35 degrees and <60 degrees from T4-L3 levels; spondylolysis and spondylolisthesis permissible, so long as the patient has not undergone any surgery nor plans to in the future." - Anonymous Online Contributor

Unverified Answer

Does this clinical trial allow for new participants to join?

"Affirmative, according to the information on clinicaltrials.gov this investigation is presently recruiting volunteers. It was first made available on June 24th 2019 and its details were last modified July 23rd of the same year. The study requires 40 people for a single locale." - Anonymous Online Contributor

Unverified Answer

What is the magnitude of participation in this clinical investigation?

"Affirmative. Records on clinicaltrials.gov demonstrate that this research is now enrolling participants, with the initial posting having been made on June 24th 2019 and recently updated on July 23rd 2019. The trial necessitates 40 patients from a single location." - Anonymous Online Contributor

Unverified Answer

Can persons under the age of 70 participate in this research?

"This research is recruiting individuals aged between 8 and 16 years old." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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