NCT04505579 The Tether™ - Vertebral Body Tethering System Post Approval Study
| NCT ID | NCT04505579 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ZimVie |
| Condition | Scoliosis Idiopathic |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-10-29 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2020-10-29 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04505579 clinical trial?
This trial is open to participants of all sexes, studying Scoliosis Idiopathic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04505579 currently recruiting?
Yes, NCT04505579 is actively recruiting participants. Contact the research team at Monica.Barascout@zimvie.com for enrollment information.
Where is the NCT04505579 trial being conducted?
This trial is being conducted at San Diego, United States, Aurora, United States, Jacksonville, United States, Atlanta, United States and 6 additional locations.
Who is sponsoring the NCT04505579 clinical trial?
NCT04505579 is sponsored by ZimVie. The trial plans to enroll 200 participants.