Treatment for Idiopathic Scoliosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Children's National Hospital, Washington, United StatesIdiopathic Scoliosis
Eligibility
< 65
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Idiopathic Scoliosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: 5 years

5 years
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 Safety

Safety Progress

1 of 3

Trial Design

0 Treatment Group

106 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

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

Eligibility Criteria

Age < 65 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are still growing and developing.
Your spine curvature is between 30 and 65 degrees as measured by the Cobb angle.
You have already tried wearing a brace but it did not help or you could not tolerate it.
You have been diagnosed with a type of curvature of the spine called idiopathic scoliosis.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - 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.