Status:
RECRUITING
The Tether™ - Vertebral Body Tethering System Post Approval Study
Lead Sponsor:
ZimVie
Collaborating Sponsors:
Setting Scoliosis Straight Foundation
Exponent, Inc.
Conditions:
Scoliosis Idiopathic
Eligibility:
All Genders
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 patie...
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-modulati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 29 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04505579
Start Date
October 29 2020
End Date
December 31 2027
Last Update
February 22 2024
Active Locations (10)
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1
Rady Children's Hospital
San Diego, California, United States, 92123
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Nemours Children's Health
Jacksonville, Florida, United States, 32207
4
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342