Scoliosis IdiopathicNCT04914507
A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
A study testing Anterior Vertebral Body Tethering in people with Scoliosis Idiopathic, run by Pediatric Spine Foundation at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- Anterior Vertebral Body Tethering
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 9 Sep 2021to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 2 countries
United States11 sites, 11 recruiting
- Recruiting
The Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
Shriners Children's Chicago
Chicago, Illinois, 60707
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37235
- Recruiting
Morgan Stanley Childrens Hospital of New York-Presbyterian
New York, New York, 10032
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
- Recruiting
Shriners Children's Portland
Portland, Oregon, 97239
- Recruiting
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101
Tenner Guillaume, MD
- Recruiting
Primary Children's Hospital
Salt Lake City, Utah, 84113
- Recruiting
Washington University
St Louis, Missouri, 63130
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Laurel Blakemore, MD
Canada1 site, 1 recruiting
- Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8LI
Kevin Smit, MD
About this study
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
- Conditions
- Scoliosis Idiopathic
- Being tested
- Anterior Vertebral Body Tethering
- Keywords
- anterior vertebral body tethering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Vertebral Body TetheringDevice
Subject will receive anterior vertebral body tethering surgery.
| Study group | Role | What they receive |
|---|---|---|
| Anterior Vertebral Body Tethering | Other | The subject is will receive anterior vertebral body tethering surgery, as clinically indicated, after all pre-operative assessments are complete. Receives: Device: Anterior Vertebral Body Tethering |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
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."
Measured: 5 years
Complications associated with both the procedure and the device
Subjects will be monitored for complications associated with both the procedure and the device.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start9 Sep 2021
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pediatric Spine Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron El-Hawary, MD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914507
- Sponsor's protocol ID
- PSSG0121
- Status last verified
- Sep 2026
- First submitted
- 31 May 2021
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29212713Trobisch 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.
PubMed 21191550Karol 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.
PubMed 18519321Samdani 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.
PubMed 25510515Crawford 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.
PubMed 20048114Samdani 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.
PubMed 24921854Miyanji 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.
PubMed 33249889Spurway 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.
PubMed 28614286Sarwahi 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.
PubMed 28604495
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
- ClinicalTrials.gov ID
- NCT04914507
- Acronym / sponsor ID
- PSSG0121
- Conditions
- Scoliosis Idiopathic
- Keywords
- anterior vertebral body tethering
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Pediatric Spine FoundationUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anterior Vertebral Body Tethering | Other | Device: Anterior Vertebral Body TetheringThe subject is will receive anterior vertebral body tethering surgery, as clinically indicated, after all pre-operative assessments are complete. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior Vertebral Body TetheringSubject will receive anterior vertebral body tethering surgery. | Device | Anterior Vertebral Body Tethering |
Primary outcome
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.
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."
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 29212713Coghlan 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.
- Background: PubMed 21191550Trobisch 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.
- Background: PubMed 18519321Karol 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.
- Background: PubMed 25510515Samdani 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.
- Background: PubMed 20048114Crawford 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.
- Background: PubMed 24921854Samdani 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.
- Background: PubMed 33249889Miyanji 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.
- Background: PubMed 28614286Spurway 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.
- Background: PubMed 28604495Sarwahi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ron El-Hawary, MD principal investigator
Dalhousie University
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Vertebral Body Tethering in people with Scoliosis Idiopathic, run by Pediatric Spine Foundation at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tyler Farber (3197501029, tfarber@pediatricspine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect on three-dimensional spine growth as compared to normal controls (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04914507, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.