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Orthopedic Device

Anterior Vertebral Body Tethering for Adolescent Idiopathic Scoliosis

N/A
Waitlist Available
Led By Lawrence Haber, MD
Research Sponsored by Lawrence Haber
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after last subject's device implantation
Awards & highlights

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
  • Osteopathy
  • Juvenile Scoliosis
  • Scoliosis
  • Spinal Diseases
  • Musculoskeletal Disorders

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years after last subject's device implantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years after last subject's device implantation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety: Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
Efficacy: Comparison of Preoperative and Postoperative Cobb Angle
Feasibility: Incidence of Successfully Implanted Tether Devices

Trial Design

1Treatment groups
Experimental Treatment
Group I: Anterior Vertebral Body TetheringExperimental Treatment1 Intervention
Subjects who will be undergoing the anterior vertebral body tethering surgery.

Find a Location

Who is running the clinical trial?

Lawrence HaberLead Sponsor
Ochsner Health SystemLead Sponsor
93 Previous Clinical Trials
184,659 Total Patients Enrolled
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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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

"This research is recruiting individuals aged between 8 and 16 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Vertebral Body Tethering Treatment for Idiopathic Scoliosis
Lawrence Haber 2019. "Vertebral Body Tethering Treatment for Idiopathic Scoliosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03802656.
~0 spots leftby Apr 2025
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