NCT04505579 · ZimVie
The Tether™ - Vertebral Body Tethering System Post Approval Study
What this study is about
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 effectiveness information from patients who have had their idiopathic scoliosis treated via anterior vertebral body tethering (AVBT) with The Tether.
View original scientific description
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.
Interventions
DEVICE
Anterior Vertebral Body Tethering
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).
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- San Diego, California
- Aurora, Colorado
- Jacksonville, Florida
- Atlanta, Georgia
- New Orleans, Louisiana
- Rochester, Minnesota
- Columbia, Missouri
- New York, New York
- Philadelphia, Pennsylvania
- Seattle, Washington
Collaborators
Setting Scoliosis Straight Foundation, Exponent, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 22, 2024 · Source of record for eligibility and locations