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

This trial does not accept healthy volunteers

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 population

The Tether™ - Vertebral Body Tethering System is indicated for skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or be intolerant to brace wear.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Anterior Vertebral Body Tethering
Device
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).

Treatment groups

200 Participants

are divided into 1 treatment group

Group A: Tether1 intervention

Trial outcomes

Primary outcomes

Rate of SAEs and device- &/or procedure-related AEs

The primary safety endpoint is the rate of Serious Adverse Events (SAEs) and device- and/or procedure-related Adverse Events (AEs)

Time frame