The Tether™ - Vertebral Body Tethering System Post Approval Study

Conditions

• Scoliosis Idiopathic

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• 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).

Study Details

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.

Key Dates

Start date

Oct 29, 2020

Status verified

Feb 2024

Primary completion

Aug 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

200 participants (estimated)

Arms

• Arm: Tether
  Patients who have received The Tether HUD for treatment of idiopathic scoliosis.

Primary Outcome Measure

Rate of SAEs and device- &/or procedure-related AEs [ Time Frame: AVBT surgery to five year post-op ]

Central Contacts

• Monica Barascout, BS
  1-303-465-8960
  [email protected]
• Kim Martinez
  1-303-465-8960
  [email protected]

Locations (10)

Find similar trials in San Diego, CA

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