ScoliosisNCT03506334
Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
A study testing AVBT using Dynesys System Components and Spine fusion in people with Scoliosis, run by Mayo Clinic at 1 site in United States.
Trial summary
The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis and compare them with a fusion cohort. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- AVBT using Dynesys System Components and Spine fusion
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2018to May 2027
- 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male \& female, age 10 years to 16 years.
- Scoliosis curve between 40-70 degrees.
- At least 1 year of growth remaining measured by Sanders bone age 4 or less or Risser stage 2 or less.
- Adolescent idiopathic scoliosis.
- Lenke 1, 2, 3C, 5 (thoracic, thoracolumbar, or thoracic and lumbar).
- Parents must be able to understand the study and sign the consent document. Assent will be obtained and documented as age appropriate.
- Patients and parents must be able to comply with study procedures and visits, including 3-month, 1-year, and 2-year follow-up visits.
Who cannot join
- Congenital, neuromuscular or syndromic scoliosis.
- Underlying neuromuscular disease.
- Pregnancy.
- Nonflexible curves (bending films show residual curve greater than 40 degrees).
- Prior surgery for scoliosis treatment.
- Patients with active systemic infection.
- Known, reported allergies to titanium, PET, or PCU. Known, reported substance abuse, including alcohol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis and compare them with a fusion cohort.
- Conditions
- Scoliosis
- Being tested
- AVBT using Dynesys System Components, Spine fusion
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVBT using Dynesys System ComponentsDevice
Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children.
Spine fusionProcedure or surgery
Children with scoliosis undergoing fusion surgery will form the control arm
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Scoliosis Patients | Experimental | Tether group Receives: Device: AVBT using Dynesys System Components |
| Pediatric Scoliosis Control Patients | Active comparator | Fusion (control) group Receives: Procedure: Spine fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision spine surgery within 2 years of index procedure
yes/no parameter, was revision surgery performed within 2 years of index procedure
Measured: 2 years
Secondary outcomes (4)
Major cobb angle curve progression greater than 10 degrees and curve magnitude < 50 degrees at latest f/u after 1st erect postop film (Tether arm)
yes/no parameter, did major Cobb angle worsen by 10 degrees and curve magnitude < 50 degrees at latest f/u after 1st erect postop film
Measured: 1 year
Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm)
yes/no parameter, did major Cobb angle worsen by 10 degrees at latest f/u after 1st erect postop film
Measured: 1 year
Curve flexibility over instrumented vertebra > 5 degrees
Flexibility films will be obtained in patients postoperatively to assess flexibility
Measured: At least 1 year postoperatively
Spinal disc health utilizing MRI
Spinal disc health will be assessed in Tether patients post-operatively using an MRI in conjunction with the Pfirrmann classification (scored I to V, where I indicated normal and V indicated the worst degeneration).
Measured: At least 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start25 Apr 2018
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Tether group 40 patients and Fusion (control) group 40 patients
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Noelle Larson, MD, Mayo Clinic
- Investigators
- A. Noelle Larson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506334
- Sponsor's protocol ID
- 17-007801
- Status last verified
- Jul 2026
- First submitted
- 3 Apr 2018
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mathew SE, Hargiss JB, Milbrandt TA, Stans AA, Shaughnessy WJ, Larson AN. Vertebral body tethering compared to posterior spinal fusion for skeletally immature adolescent idiopathic scoliosis patients: preliminary results from a matched case-control study. Spine Deform. 2022 Sep;10(5):1123-1131. doi: 10.1007/s43390-022-00519-3. Epub 2022 May 24.
PubMed 35610543
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
- ClinicalTrials.gov ID
- NCT03506334
- Acronym / sponsor ID
- 17-007801
- Conditions
- Scoliosis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 24 Apr 2018 (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.
The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis and compare them with a fusion cohort.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Tether group 40 patients and Fusion (control) group 40 patients
| Arm | Type | Receives |
|---|---|---|
| Pediatric Scoliosis Patients | Experimental | Device: AVBT using Dynesys System ComponentsTether group |
| Pediatric Scoliosis Control Patients | Active comparator | Procedure: Spine fusionFusion (control) group |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male \& female, age 10 years to 16 years.
- Scoliosis curve between 40-70 degrees.
- At least 1 year of growth remaining measured by Sanders bone age 4 or less or Risser stage 2 or less.
- Adolescent idiopathic scoliosis.
- Lenke 1, 2, 3C, 5 (thoracic, thoracolumbar, or thoracic and lumbar).
Key exclusion criteria (7 listed)
- Congenital, neuromuscular or syndromic scoliosis.
- Underlying neuromuscular disease.
- Pregnancy.
- Nonflexible curves (bending films show residual curve greater than 40 degrees).
- Prior surgery for scoliosis treatment.
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 |
|---|---|---|
| AVBT using Dynesys System ComponentsZimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children. | Device | Pediatric Scoliosis Patients |
| Spine fusionChildren with scoliosis undergoing fusion surgery will form the control arm | Procedure or surgery | Pediatric Scoliosis Control Patients |
Primary outcome
Revision spine surgery within 2 years of index procedure
Time frame: 2 years
yes/no parameter, was revision surgery performed within 2 years of index procedure
4 secondary outcomes
Major cobb angle curve progression greater than 10 degrees and curve magnitude < 50 degrees at latest f/u after 1st erect postop film (Tether arm)
Time frame: 1 year
Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm)
Time frame: 1 year
Curve flexibility over instrumented vertebra > 5 degrees
Time frame: At least 1 year postoperatively
Spinal disc health utilizing MRI
Time frame: At least 1 year postoperatively
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 7 Jul 2026.
- Derived from this study: PubMed 35610543Mathew SE, Hargiss JB, Milbrandt TA, Stans AA, Shaughnessy WJ, Larson AN. Vertebral body tethering compared to posterior spinal fusion for skeletally immature adolescent idiopathic scoliosis patients: preliminary results from a matched case-control study. Spine Deform. 2022 Sep;10(5):1123-1131. doi: 10.1007/s43390-022-00519-3. Epub 2022 May 24.
- 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.
A. Noelle Larson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVBT using Dynesys System Components and Spine fusion in people with Scoliosis, run by Mayo Clinic at 1 site in United States.
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 7 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revision spine surgery within 2 years of index procedure (time frame: 2 years). 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 NCT03506334, which also lists 1 linked publication.
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 7 Jul 2026.