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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04914507
Recruitment Status : Recruiting
First Posted : June 4, 2021
Last Update Posted : July 6, 2022
Sponsor:
Information provided by (Responsible Party):
Pediatric Spine Foundation

Brief 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

Condition or disease Intervention/treatment Phase
Scoliosis Idiopathic Device: Anterior Vertebral Body Tethering Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
Actual Study Start Date : September 9, 2021
Estimated Primary Completion Date : September 2028
Estimated Study Completion Date : September 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Anterior Vertebral Body Tethering
The subject is will receive anterior vertebral body tethering surgery, as clinically indicated, after all pre-operative assessments are complete.
Device: Anterior Vertebral Body Tethering
Subject will receive anterior vertebral body tethering surgery.




Primary Outcome Measures :
  1. The effect on three-dimensional spine growth as compared to normal controls [ Time Frame: 5 years ]
    The three-dimensional spine growth of the subjects will be measured at each study timepoint and compared to known normal controls.

  2. Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity [ Time Frame: 5 years ]
    Subjects who maintain a major Cobb angle less than or equal to 50 degrees at skeletal maturity will be considered a "success."

  3. Complications associated with both the procedure and the device [ Time Frame: 5 years ]
    Subjects will be monitored for complications associated with both the procedure and the device.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Skeletally immature patients that receive AVBT surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis. Specifically:

  • 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

Exclusion Criteria:

  • Presence of any systemic infection, local infection, or skin compromise at the anticipated surgical site
  • Prior spinal surgery at the level(s) to be treated
  • Evidence of documented poor bone quality
  • Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions as determined by the treating physician
  • Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent
  • Unwillingness to sign Informed Consent Form and participate in study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04914507


Contacts
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Contact: Tyler Farber 3197501029 tfarber@pediatricspine.org
Contact: Tricia St. Hilaire 4844106413 tsthilaire@pediatricspine.org

Locations
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United States, District of Columbia
Children's National Hospital Recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: Laurel Blakemore, MD         
United States, Minnesota
Gillette Children's Specialty Healthcare Recruiting
Saint Paul, Minnesota, United States, 55101
Principal Investigator: Tenner Guillaume, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63130
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
United States, Oregon
Shriners Children's Portland Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
The Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Canada, Ontario
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8LI
Principal Investigator: Kevin Smit, MD         
Sponsors and Collaborators
Pediatric Spine Foundation
Investigators
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Principal Investigator: Ron El-Hawary, MD Dalhousie University
Publications:

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Responsible Party: Pediatric Spine Foundation
ClinicalTrials.gov Identifier: NCT04914507    
Other Study ID Numbers: PSSG0121
First Posted: June 4, 2021    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Pediatric Spine Foundation:
anterior vertebral body tethering
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases