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Device

Anterior body tether (ABT) for Adolescent Idiopathic Scoliosis

N/A

Waitlist Available

Led By Suken Shah, MD

Research Sponsored by Nemours Children's Clinic

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 cobb angle will be measured prior to surgery, at 6 moths, 1 year and 2 years past surgery.

Awards & highlights

Study Summary

This trial will test a new surgical method for treating scoliosis in children. The goal is to see if it is safe and effective.

Eligible Conditions

Adolescent Idiopathic Scoliosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cobb angle will be measured prior to surgery, at 6 moths, 1 year and 2 years past surgery.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cobb angle will be measured prior to surgery, at 6 moths, 1 year and 2 years past surgery.

This trial's timeline: 3 weeks for screening, Varies for treatment, and cobb angle will be measured prior to surgery, at 6 moths, 1 year and 2 years past surgery. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of adverse events after the procedure

Secondary outcome measures

Cobb angle in degrees

Trial Design

1Treatment groups

Experimental Treatment

Group I: Anterior Vertebral TetheringExperimental Treatment1 Intervention

Anterior Vertebral Tether Vertebral body tethering done through anterior spine surgery under anesthesia.

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Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor

124 Previous Clinical Trials

18,101 Total Patients Enrolled

Suken Shah, MDPrincipal InvestigatorNemours-AIDHC

Frequently Asked Questions

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

How many individuals are involved in this research project?

"Affirmative. According to the information hosted on clinicaltrials.gov, this research endeavour is actively recruiting prospective subjects. It was initially advertised on September 1st 2019 and modified most recently on April 4th 2022; with 30 individuals required at a single location for participation in the trial."

Answered by AI

Are there any present opportunities to join this experiment?

"Clinicaltrials.gov confirms that this clinical trial is in the process of recruiting suitable participants, beginning on September 1st 2019 and most recently updated on April 4th 2022."

Answered by AI

Am I a suitable candidate to participate in this experiment?

"This trial is targeting 30 patients aged 8 to 16 displaying androgen-insensitivity syndrome. For qualification, applicants must have a Sanders bone age of not exceeding 4 years old, a Thoracic curve between 35 degrees and 60 degrees in magnitude, no previous surgery for Spondylolysis or Spondylolisthesis (unless non-operative) with no future plans for surgical intervention, an Lumbar curve less than 35 degrees in size as well as being free from spina bifida occulta."

Answered by AI

Is this clinical trial open to individuals older than thirty years of age?

"This trial has established that participants should be between 8 and 16 years of age. There is an additional corpus of 68 trials for those under the legal age, as well as 14 studies targeting seniors aged 65 or over."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety Outcomes of Vertebral Body Tethering Technique

2019. "Safety Outcomes of Vertebral Body Tethering Technique". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04119284.