The Tether™ - Vertebral Body Tethering System Post Approval Study
ConditionScoliosis Idiopathic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorZimVie
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Anterior Vertebral Body Tethering
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov