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Procedure

Spinal Tethering for Scoliosis

N/A
Recruiting
Led By Ron El-Hawary, MD
Research Sponsored by Pediatric Spine Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Failed or intolerant to bracing
Osseous structure dimensionally adequate for screw fixation
Must not have
Medical or surgical conditions precluding potential benefit of spinal surgery
Presence of systemic infection, local infection, or skin compromise at surgical site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial reports the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically in regards to effect on three-dimensional spine growth, maintenance of major Cobb angle, and complications associated with both the procedure and the device.

Who is the study for?
This trial is for skeletally immature children with idiopathic scoliosis who have a major Cobb angle between 30° and 65°, have not had prior spinal surgery at the levels to be treated, and are unable to use bracing. They must also be able to return for follow-up visits and agree to participate in study procedures.
What is being tested?
The trial studies Anterior Vertebral Body Tethering (AVBT), a new minimally invasive technique for controlling spine curve progression in children with scoliosis. It will compare long-term outcomes of AVBT patients with normal controls regarding spine growth and maintenance of curvature.
What are the potential side effects?
Potential side effects may include complications related to the surgical procedure or device used in AVBT such as infection, adverse reaction to implant materials, or issues arising from screw fixation within the bone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Bracing did not work or caused me issues.
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My bones are strong enough for screw fixation.
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I have been diagnosed with idiopathic scoliosis.
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I am scheduled for AVBT surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition that makes spinal surgery not beneficial for me.
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I have an infection or skin issue at the surgery area.
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I have had surgery on my spine where I am now seeking treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complications associated with both the procedure and the device
Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity
The effect on three-dimensional spine growth as compared to normal controls

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Anterior Vertebral Body TetheringExperimental Treatment1 Intervention
The subject is will receive anterior vertebral body tethering surgery, as clinically indicated, after all pre-operative assessments are complete.

Find a Location

Who is running the clinical trial?

Pediatric Spine FoundationLead Sponsor
1 Previous Clinical Trials
210 Total Patients Enrolled
Ron El-Hawary, MDPrincipal InvestigatorDalhousie University
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Anterior Vertebral Body Tethering (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04914507 — N/A
Idiopathic Scoliosis Clinical Trial 2023: Anterior Vertebral Body Tethering Highlights & Side Effects. Trial Name: NCT04914507 — N/A
Idiopathic Scoliosis Research Study Groups: Anterior Vertebral Body Tethering
Anterior Vertebral Body Tethering (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04914507 — N/A
~56 spots leftby Sep 2028
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