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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of idiopathic scoliosis

• Planned recipient of AVBT surgical treatment

• Skeletally immature

• Major Cobb angle ≥30° and ≤65°

• Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging

• Failed or intolerant to bracing

Locations
United States
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Illinois
Shriners Children's Chicago
RECRUITING
Chicago
Minnesota
Gillette Children's Specialty Healthcare
RECRUITING
Saint Paul
Missouri
Washington University
RECRUITING
St Louis
New York
Morgan Stanley Childrens Hospital of New York-Presbyterian
RECRUITING
New York
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Oregon
Shriners Children's Portland
RECRUITING
Portland
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
South Carolina
The Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Vanderbilt University
RECRUITING
Nashville
Utah
Primary Children's Hospital
RECRUITING
Salt Lake City
Other Locations
Canada
Children's Hospital of Eastern Ontario
RECRUITING
Ottawa
Contact Information
Primary
Tyler Farber
tfarber@pediatricspine.org
3197501029
Backup
Tricia St. Hilaire
tsthilaire@pediatricspine.org
4844106413
Time Frame
Start Date: 2021-09-09
Estimated Completion Date: 2029-09
Participants
Target number of participants: 106
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Pediatric Spine Foundation

This content was sourced from clinicaltrials.gov