Recruiting

Tether™

Sponsor:

ZimVie

Code:

NCT04505579

Conditions

Scoliosis Idiopathic

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Anterior Vertebral Body Tethering

Study Details

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 patients who have had their idiopathic scoliosis treated via anterior vertebral body tethering (AVBT) with The Tether.

Conditions

Scoliosis Idiopathic

Study ID

NCT04505579

Start date

Oct 29, 2020

Status verified date

Feb, 2024

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Tether

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

Interventions

Anterior 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).

Primary outcome measure

  • Rate of SAEs and device- &/or procedure-related AEs [ Time Frame: AVBT surgery to five year post-op ]
  • Percentage of subjects with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery [ Time Frame: AVBT surgery to five year post-op ]

Central Contacts and Locations

Central contacts

Monica Barascout, BS

1-303-465-8960Monica.Barascout@zimvie.com

Kim Martinez

1-303-465-8960Kim.Martinez@zimvie.com

Locations

Rady Children's Hospital

Recruiting

San Diego, California, United States, 92123

Contacts

Peter O Newton, MD

858-966-6789

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30342

Ochsner Health

Recruiting

New Orleans, Louisiana, United States, 70121

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

A. Noelle Larson, MD

507-284-3660Larson.noelle@mayo.edu

University of Missouri - Columbia

Recruiting

Columbia, Missouri, United States, 65201

Contacts

Daniel Hoernschemeyer, MD

573-882-2663

Mount Sinai

Recruiting

New York, New York, United States, 10029

Shriners Children's Hopital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Seattle Children's

Recruiting

Seattle, Washington, United States, 98105

More Information

Sponsor

ZimVie

Last update posted

Feb 22, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by ZimVie on 2024-02-22.