Scoliosis IdiopathicNCT04505579
The Tether™ - Vertebral Body Tethering System Post Approval Study
An observational study of Scoliosis Idiopathic, run by ZimVie at 10 sites in United States.
Trial summary
This study is an opportunity to provide continued reasonable assurance of the safety and probable benefit of The Tether HUD. The study will collect long term safety and efficacy information from patients who have had their idiopathic scoliosis treated via anterior vertebral body tethering (AVBT) with The Tether. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- Anterior Vertebral Body Tethering
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 10 sitesUnited States
- Study dates
- 29 Oct 2020to 31 Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The Tether™ - Vertebral Body Tethering System is indicated for skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or be intolerant to brace wear.
Who may be able to join
- Diagnosis of progressive idiopathic scoliosis
- Skeletally immature, based on both Risser (<5) and Sanders (<8) assessments
- Major Cobb angle ≥30° and ≤65°
- Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
- Failed or intolerant to bracing
Who cannot join
- Presence of any systemic infection, local infection, or skin compromise at the surgical site
- Prior spinal surgery at the level(s) to be treated
- Documented poor bone quality, defined as a T-score -1.5 or less
- 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
- 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
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 9 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
Joshua Murphy, MD
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Mark Erickson, MD
- Recruiting
University of Missouri - Columbia
Columbia, Missouri, 65201
Daniel Hoernschemeyer, MD, 573-882-2663
- Active, not recruiting
Nemours Children's Health
Jacksonville, Florida, 32207
- Recruiting
Ochsner Health
New Orleans, Louisiana, 70121
Lawrence Haber, MD
- Recruiting
Mount Sinai
New York, New York, 10029
Baron Lonner, MD
- Recruiting
Shriners Children's Hopital
Philadelphia, Pennsylvania, 19140
Amer F Samdani
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
A. Noelle Larson, MD, 507-284-3660, Larson.noelle@mayo.edu
- Recruiting
Rady Children's Hospital
San Diego, California, 92123
Peter O Newton, MD, 858-966-6789
- Recruiting
Seattle Children's
Seattle, Washington, 98105
Burt Yaszay, MD
About this study
This study is an opportunity to provide continued reasonable assurance of the safety and probable benefit of The Tether HUD. The study will collect long term safety and efficacy information from patients who have had their idiopathic scoliosis treated via anterior vertebral body tethering (AVBT) with The Tether.
Read the detailed description
While spinal fusion remains the standard surgical treatment for progressive idiopathic scoliosis, concerns about the long-term effects of spinal fusion have led to the investigation of growth-modulation techniques. Anterior Vertebral Body Tethering (AVBT) is one such technique that utilizes growth modulation to remodel the shape of the vertebra and straighten scoliotic curves in skeletally immature individuals. In this technique, screws are inserted at each vertebral level for the length of the convex side of the curve. A strong cord is connected through the screw tulip heads and used to initially straighten the curve as each level is fixed with a set screw. Following surgery and during the growth period the spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated in areas of decreased pressure or tension (concave side). Following this principle, AVBT has been shown to alter spinal growth with the potential to correct scoliosis while maintaining spine flexibility.
The objective of the study is to assess the ongoing safety and probable benefit of The Tether HUD which was approved by the FDA under an HDE. Subject enrollment and data collection will be managed by the Harms Study Group (HSG) and Setting Scoliosis Straight Foundation (SSSF) Registry. Institutions that are HSG members or affiliates, with Investigators/surgeons that are trained and approved to perform surgeries with The Tether, will participate in the registry. Ten sites from this group will be identified as study sites specific to this Tether post-approval study (PAS). Consecutive subjects from these sites, that meet the eligibility criteria of this study, will be flagged in the registry as the PAS cohort and the study endpoints will be assessed across this population.
- Conditions
- Scoliosis Idiopathic
- Being tested
- 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
Also called AVBT
Anterior Vertebral Body Tethering (AVBT) is a technique that utilizes growth modulation to remodel the shape of the vertebra and straighten scoliotic curves in skeletally immature individuals. In this technique, screws are inserted at each vertebral level for the length of the convex side of the curve. A strong cord is connected through the screw tulip heads and used to initially straighten the curve as each level is fixed with a set screw. Following surgery and during the growth period the spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated in areas of decreased pressure or tension (concave side).
| Study group | Role | What they receive |
|---|---|---|
| Tether | Patients who have received The Tether HUD for treatment of idiopathic scoliosis. Receives: Device: Anterior Vertebral Body Tethering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of SAEs and device- &/or procedure-related AEs
The primary safety endpoint is the rate of Serious Adverse Events (SAEs) and device- and/or procedure-related Adverse Events (AEs)
Measured: AVBT surgery to five year post-op
Percentage of subjects with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery
The primary probable benefit endpoint is the percentage of patients with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery
Measured: AVBT surgery to five year post-op
Secondary outcomes (11)
Adverse Events
Rates of overall Adverse Events; relatedness, severity, time to event
Measured: AVBT surgery to five year post-op
Reoperation
Rates and types of reoperation
Measured: AVBT surgery to five year post-op
Number of participants with new curves that develop above or below the tethered portion of the spine.
Determined by radiographic assessment, defined as a new curve development with Cobb angle measurement greater than or equal to 40 degrees.
Measured: AVBT surgery to five year post-op
Number of participants with secondary curves that progress to the point of clinical significance.
Determined by radiographic assessment, typically defined as an increase in secondary Cobb angle measurement greater than or equal to 10 degrees, or medical intervention/ intent to treat.
Measured: AVBT surgery to five year post-op
Number of participants with device integrity failures including cord breakage and screw migration.
Measured: AVBT surgery to five year post-op
Mean (SD) and distributions of sagittal balance (mm) from pre-op through last visit
Sagittal balance is assessed on the lateral radiograph by measuring the difference (i.e. distance) between posterosuperior aspect of the S1 vertebral body and the plumb line.
Measured: Baseline to five year post-op
Mean (SD) and distributions of lumbar lordosis (degrees) from pre-op through last visit.
Lumbar lordosis is defined as the angle at the intersection of lines perpendicular to lines parallel to the superior endplate of T12 and the superior endplate of S1.
Measured: Baseline to five year post-op
Mean score of Scoliosis Research Society 22r Patient Questionnaire
Self-reported outcomes of function, pain, self-image, mental health, and satisfaction. Mean score; 5 (Best) - 1 (Worst)
Measured: Baseline to five year post-op
Number of participants with compromised lung function
Comparison of the measured lung function (forced expiratory volume (FEV1), forced vital capacity (FVC) and FEV1/FVC) to predicted values, lower and upper limits of normal to determine if lung function is within the limits of the normal population.
Measured: Baseline to five year post-op
Measurement (degrees rotation) of trunk shape by scoliometer device. Mean (SD) [min, max] will be reported.
Measurements of trunk shape or rib hump will be collected preoperatively and at each follow-up visit. A standard scoliometer device will be used to measure the rib hump in the thoracic and/or lumbar regions of the spine, as applicable. The scoliometer is laid across the curve at right angles with the 0° mark at the spinous process and resting gently on the skin, not pressed down. The degrees of rotation are read and recorded.
Measured: Baseline to five year post-op
Trunk flexibility as determined by distance (cm) of flexion and lateral bend using fingertip to floor method.
Measured: Baseline to five year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start29 Oct 2020
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- ZimVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Setting Scoliosis Straight Foundation, Exponent, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505579
- Sponsor's protocol ID
- RAU2019-40S
- Status last verified
- Feb 2024
- First submitted
- 20 Jul 2020
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Tether™ - Vertebral Body Tethering System Post Approval Study
- ClinicalTrials.gov ID
- NCT04505579
- Acronym / sponsor ID
- RAU2019-40S
- Conditions
- Scoliosis Idiopathic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ZimVieIndustry (pharma, biotech, devices)
- Collaborators
- Setting Scoliosis Straight Foundation, Exponent, Inc.
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Aug 2020 (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.
This study is an opportunity to provide continued reasonable assurance of the safety and probable benefit of The Tether HUD. The study will collect long term safety and efficacy information from patients who have had their idiopathic scoliosis treated via anterior vertebral body tethering (AVBT) with The Tether.
Detailed description
While spinal fusion remains the standard surgical treatment for progressive idiopathic scoliosis, concerns about the long-term effects of spinal fusion have led to the investigation of growth-modulation techniques. Anterior Vertebral Body Tethering (AVBT) is one such technique that utilizes growth modulation to remodel the shape of the vertebra and straighten scoliotic curves in skeletally immature individuals. In this technique, screws are inserted at each vertebral level for the length of the convex side of the curve. A strong cord is connected through the screw tulip heads and used to initially straighten the curve as each level is fixed with a set screw. Following surgery and during the growth period the spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated in areas of decreased pressure or tension (concave side). Following this principle, AVBT has been shown to alter spinal growth with the potential to correct scoliosis while maintaining spine flexibility.
The objective of the study is to assess the ongoing safety and probable benefit of The Tether HUD which was approved by the FDA under an HDE. Subject enrollment and data collection will be managed by the Harms Study Group (HSG) and Setting Scoliosis Straight Foundation (SSSF) Registry. Institutions that are HSG members or affiliates, with Investigators/surgeons that are trained and approved to perform surgeries with The Tether, will participate in the registry. Ten sites from this group will be identified as study sites specific to this Tether post-approval study (PAS). Consecutive subjects from these sites, that meet the eligibility criteria of this study, will be flagged in the registry as the PAS cohort and the study endpoints will be assessed across this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tether | – | Device: Anterior Vertebral Body TetheringPatients who have received The Tether HUD for treatment of idiopathic scoliosis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Tether™ - Vertebral Body Tethering System is indicated for skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or be intolerant to brace wear.
Key inclusion criteria (5 listed)
- Diagnosis of progressive idiopathic scoliosis
- Skeletally immature, based on both Risser (<5) and Sanders (<8) assessments
- Major Cobb angle ≥30° and ≤65°
- Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
- Failed or intolerant to bracing
Key exclusion criteria (6 listed)
- Presence of any systemic infection, local infection, or skin compromise at the surgical site
- Prior spinal surgery at the level(s) to be treated
- Documented poor bone quality, defined as a T-score -1.5 or less
- 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
- 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 TetheringAlso: AVBTAnterior Vertebral Body Tethering (AVBT) is a technique that utilizes growth modulation to remodel the shape of the vertebra and straighten scoliotic curves in skeletally immature individuals. In this technique, screws are inserted at each vertebral level for the length of the convex side of the curve. A strong cord is connected through the screw tulip heads and used to initially straighten the curve as each level is fixed with a set screw. Following surgery and during the growth period the spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated in areas of decreased pressure or tension (concave side). | Device | Tether |
Primary outcome
Rate of SAEs and device- &/or procedure-related AEs
Time frame: AVBT surgery to five year post-op
The primary safety endpoint is the rate of Serious Adverse Events (SAEs) and device- and/or procedure-related Adverse Events (AEs)
Percentage of subjects with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery
Time frame: AVBT surgery to five year post-op
The primary probable benefit endpoint is the percentage of patients with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery
11 secondary outcomes
Adverse Events
Time frame: AVBT surgery to five year post-op
Reoperation
Time frame: AVBT surgery to five year post-op
Number of participants with new curves that develop above or below the tethered portion of the spine.
Time frame: AVBT surgery to five year post-op
Number of participants with secondary curves that progress to the point of clinical significance.
Time frame: AVBT surgery to five year post-op
Number of participants with device integrity failures including cord breakage and screw migration.
Time frame: AVBT surgery to five year post-op
Mean (SD) and distributions of sagittal balance (mm) from pre-op through last visit
Time frame: Baseline to five year post-op
Mean (SD) and distributions of lumbar lordosis (degrees) from pre-op through last visit.
Time frame: Baseline to five year post-op
Mean score of Scoliosis Research Society 22r Patient Questionnaire
Time frame: Baseline to five year post-op
Number of participants with compromised lung function
Time frame: Baseline to five year post-op
Measurement (degrees rotation) of trunk shape by scoliometer device. Mean (SD) [min, max] will be reported.
Time frame: Baseline to five year post-op
Trunk flexibility as determined by distance (cm) of flexion and lateral bend using fingertip to floor method.
Time frame: Baseline to five year post-op
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 22 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic, run by ZimVie at 10 sites 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 5 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 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Contact Monica Barascout, BS (1-303-465-8960, Monica.Barascout@zimvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of SAEs and device- &/or procedure-related AEs (time frame: AVBT surgery to five year post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2024.