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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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

Frequently Asked Questions

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

Are there any slots available to join this clinical experiment?

"Affirmative, the clinicaltrials.gov database verifies that this medical experiment is in search of participants who meet its criteria. The trial was initially listed on September 9th 2021 and revised most recently on July 5th 2022; 106 patients are needed to be recruited from nine sites across the country."

Answered by AI

What is the total quantity of health care facilities that are currently administrating this experiment?

"Nine locations are currently looking for trial participants, including Shriners Children's Portland in Portland, Children's National Hospital in Washington, and Gillette Children's Specialty Healthcare in Saint Paul. Other facilities exist as well."

Answered by AI

How many individuals are partaking in this research endeavor?

"The medical study necessitates recruiting 106 suitable participants across two sites: Shriners Children's Portland in Portland, Oregon and Children's National Hospital in Washington D.C."

Answered by AI
Recent research and studies
~68 spots leftby Sep 2028