Back to resultsA Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
Primary Purpose
Scoliosis Idiopathic
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Anterior Vertebral Body Tethering
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis Idiopathic focused on measuring anterior vertebral body tethering
Eligibility 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
Sites / Locations
- Children's National HospitalRecruiting
- Gillette Children's Specialty HealthcareRecruiting
- Washington UniversityRecruiting
- Cincinnati Children's Hospital Medical CenterRecruiting
- Shriners Children's PortlandRecruiting
- Children's Hospital of PhiladelphiaRecruiting
- The Medical University of South CarolinaRecruiting
- Primary Children's HospitalRecruiting
- Children's Hospital of Eastern OntarioRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Anterior Vertebral Body Tethering
Arm Description
The subject is will receive anterior vertebral body tethering surgery, as clinically indicated, after all pre-operative assessments are complete.
Outcomes
Primary Outcome Measures
The effect on three-dimensional spine growth as compared to normal controls
The three-dimensional spine growth of the subjects will be measured at each study timepoint and compared to known normal controls.
Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity
Subjects who maintain a major Cobb angle less than or equal to 50 degrees at skeletal maturity will be considered a "success."
Complications associated with both the procedure and the device
Subjects will be monitored for complications associated with both the procedure and the device.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04914507
Brief Title
A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
Official Title
A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
September 2028 (Anticipated)
Study Completion Date
September 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pediatric Spine Foundation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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:
The effect on three-dimensional spine growth as compared to normal controls
Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity
Complications associated with both the procedure and the device
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic
Keywords
anterior vertebral body tethering
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anterior Vertebral Body Tethering
Arm Type
Other
Arm Description
The subject is will receive anterior vertebral body tethering surgery, as clinically indicated, after all pre-operative assessments are complete.
Intervention Type
Device
Intervention Name(s)
Anterior Vertebral Body Tethering
Intervention Description
Subject will receive anterior vertebral body tethering surgery.
Primary Outcome Measure Information:
Title
The effect on three-dimensional spine growth as compared to normal controls
Description
The three-dimensional spine growth of the subjects will be measured at each study timepoint and compared to known normal controls.
Time Frame
5 years
Title
Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity
Description
Subjects who maintain a major Cobb angle less than or equal to 50 degrees at skeletal maturity will be considered a "success."
Time Frame
5 years
Title
Complications associated with both the procedure and the device
Description
Subjects will be monitored for complications associated with both the procedure and the device.
Time Frame
5 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tyler Farber
Phone
3197501029
Email
tfarber@pediatricspine.org
First Name & Middle Initial & Last Name or Official Title & Degree
Tricia St. Hilaire
Phone
4844106413
Email
tsthilaire@pediatricspine.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron El-Hawary, MD
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurel Blakemore, MD
Facility Name
Gillette Children's Specialty Healthcare
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tenner Guillaume, MD
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Shriners Children's Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
The Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8LI
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Smit, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29212713
Citation
Coghlan RF, Oberdorf JA, Sienko S, Aiona MD, Boston BA, Connelly KJ, Bahney C, LaRouche J, Almubarak SM, Coleman DT, Girkontaite I, von der Mark K, Lunstrum GP, Horton WA. A degradation fragment of type X collagen is a real-time marker for bone growth velocity. Sci Transl Med. 2017 Dec 6;9(419):eaan4669. doi: 10.1126/scitranslmed.aan4669.
Results Reference
background
PubMed Identifier
21191550
Citation
Trobisch P, Suess O, Schwab F. Idiopathic scoliosis. Dtsch Arztebl Int. 2010 Dec;107(49):875-83; quiz 884. doi: 10.3238/arztebl.2010.0875. Epub 2010 Dec 10.
Results Reference
background
PubMed Identifier
18519321
Citation
Karol LA, Johnston C, Mladenov K, Schochet P, Walters P, Browne RH. Pulmonary function following early thoracic fusion in non-neuromuscular scoliosis. J Bone Joint Surg Am. 2008 Jun;90(6):1272-81. doi: 10.2106/JBJS.G.00184.
Results Reference
background
PubMed Identifier
25510515
Citation
Samdani AF, Ames RJ, Kimball JS, Pahys JM, Grewal H, Pelletier GJ, Betz RR. Anterior vertebral body tethering for immature adolescent idiopathic scoliosis: one-year results on the first 32 patients. Eur Spine J. 2015 Jul;24(7):1533-9. doi: 10.1007/s00586-014-3706-z. Epub 2014 Dec 16.
Results Reference
background
PubMed Identifier
20048114
Citation
Crawford CH 3rd, Lenke LG. Growth modulation by means of anterior tethering resulting in progressive correction of juvenile idiopathic scoliosis: a case report. J Bone Joint Surg Am. 2010 Jan;92(1):202-9. doi: 10.2106/JBJS.H.01728. No abstract available.
Results Reference
background
PubMed Identifier
24921854
Citation
Samdani AF, Ames RJ, Kimball JS, Pahys JM, Grewal H, Pelletier GJ, Betz RR. Anterior vertebral body tethering for idiopathic scoliosis: two-year results. Spine (Phila Pa 1976). 2014 Sep 15;39(20):1688-93. doi: 10.1097/BRS.0000000000000472.
Results Reference
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PubMed Identifier
33249889
Citation
Miyanji F, Pawelek J, Nasto LA, Rushton P, Simmonds A, Parent S. Safety and efficacy of anterior vertebral body tethering in the treatment of idiopathic scoliosis. Bone Joint J. 2020 Dec;102-B(12):1703-1708. doi: 10.1302/0301-620X.102B12.BJJ-2020-0426.R1.
Results Reference
background
PubMed Identifier
28614286
Citation
Spurway AJ, Hurry JK, Gauthier L, Orlik B, Chukwunyerenwa CK, Kishta WE, El-Hawary R. Three-dimensional True Spine Length: A Novel Technique for Assessing the Outcomes of Scoliosis Surgery. J Pediatr Orthop. 2017 Dec;37(8):e631-e637. doi: 10.1097/BPO.0000000000001031.
Results Reference
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PubMed Identifier
28604495
Citation
Sarwahi V, Wendolowski S, Gecelter R, Maguire K, Gambassi M, Orlando D, Lo Y, Amaral T. When Do Patients Return to Physical Activities and Athletics After Scoliosis Surgery?: A Validated Patient Questionnaire Based Study. Spine (Phila Pa 1976). 2018 Feb 1;43(3):167-171. doi: 10.1097/BRS.0000000000002284.
Results Reference
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A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
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