The Tether™ - Vertebral Body Tethering System Post Approval Study

NCT04505579 | Recruiting DMC FDA Device

• 1 other identifier: RAU2019-40S
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 10

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

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  The primary probable benefit endpoint is the percentage of patients with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery

  AVBT surgery to five year post-op

Secondary Outcomes (11)

• Adverse Events

  AVBT surgery to five year post-op

• Reoperation

  AVBT surgery to five year post-op

• Number of participants with new curves that develop above or below the tethered portion of the spine.

  AVBT surgery to five year post-op

• Number of participants with secondary curves that progress to the point of clinical significance.

  AVBT surgery to five year post-op

• Number of participants with device integrity failures including cord breakage and screw migration.

  AVBT surgery to five year post-op

Study Arms (1)

Tether

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

Device: Anterior Vertebral Body Tethering

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).

Also known as: AVBT

Tether

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ZimVie: lead
• Setting Scoliosis Straight Foundation: collaborator
• Exponent, Inc.: collaborator

Study Sites (10)

Rady Children's Hospital

San Diego, California, 92123, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Nemours Children's Health

Jacksonville, Florida, 32207, United States

ACTIVE NOT RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

RECRUITING

Ochsner Health

New Orleans, Louisiana, 70121, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

University of Missouri - Columbia

Columbia, Missouri, 65201, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

Shriners Children's Hopital

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Seattle Children's

Seattle, Washington, 98105, United States

RECRUITING

Central Study Contacts

Monica Barascout, BS

CONTACT

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

Kim Martinez

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Post-Marketing Study: Yes

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: August 10, 2020
• Study Start: October 29, 2020
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

US (10)