The Tether™ - Vertebral Body Tethering System Post Approval Study
ZimVie
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.
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 initi…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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 cond…
Interventions
- DeviceAnterior 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).
Locations (10)
- Rady Children's HospitalSan Diego, California
- Children's Hospital ColoradoAurora, Colorado
- Nemours Children's HealthJacksonville, Florida
- Children's Healthcare of AtlantaAtlanta, Georgia
- Ochsner HealthNew Orleans, Louisiana
- Mayo ClinicRochester, Minnesota