A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Pediatric Spine Foundation
Study ID
NCT04914507
Status
Recruiting
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Conditions

  • Scoliosis Idiopathic

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Anterior Vertebral Body Tethering — DEVICE
    Subject will receive anterior vertebral body tethering surgery.

Study Details

Anterior vertebral body tethering (AVBT) is a novel, minimally invasive, growth modulation technique that was recently approved by the FDA under a Humanitarian Device Exemption (HDE). The goal of AVBT is to control curve progression by applying compression on the convex side of the spine deformity. While there has been great initial enthusiasm about the technique as an alternate treatment option to spinal fusion for skeletally immature children with scoliosis, there is a need to better understand the long-term outcomes. The purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically: 1. The effect on three-dimensional spine growth as compared to normal controls 2. Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity 3. Complications associated with both the procedure and the device

Key Dates

Start date
Sep 9, 2021
Status verified
Nov 2023
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
106 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Anterior Vertebral Body Tethering
    The subject is will receive anterior vertebral body tethering surgery, as clinically indicated, after all pre-operative assessments are complete.

Primary Outcome Measure

The effect on three-dimensional spine growth as compared to normal controls [ Time Frame: 5 years ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010
Laurel Blakemore, MD (PRINCIPAL_INVESTIGATOR)
Shriners Children's ChicagoChicagoIllinois60707-
Gillette Children's Specialty HealthcareSaint PaulMinnesota55101
Tenner Guillaume, MD (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63130-
Morgan Stanley Childrens Hospital of New York-PresbyterianNew YorkNew York10032-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Shriners Children's PortlandPortlandOregon97239-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
The Medical University of South CarolinaCharlestonSouth Carolina29425-
Vanderbilt UniversityNashvilleTennessee37235-
Primary Children's HospitalSalt Lake CityUtah84113-

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By research site
Children's National Hospital· Washington D.C., DCShriners Children's Chicago· Chicago, ILGillette Children's Specialty Healthcare· Saint Paul, MNWashington University· St Louis, MOMorgan Stanley Childrens Hospital of New York-Presbyterian· New York, NYCincinnati Children's Hospital Medical Center· Cincinnati, OH

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