Safety and Efficacy Study of Spinal Tethering

NCT ID: NCT02897453

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-06
• Study Completion Date: 2022-10-31

Brief Summary

This study is an opportunity to gather long term safety and efficacy information from patients who have had their scoliosis treated via anterior vertebral body tethering (VBT).

Detailed Description

Participants in this study will have already been implanted with a vertebral body tethering device. Patients will be recruited for prospective follow-up to enable systematic data capture from the point of study entry to their 18th birth year and skeletal maturity. Over the course of their follow-up clinical outcomes, patient reported outcomes, and radiographic outcomes will be tracked.

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The Spinal Tethering System group

Patients with adolescent idiopathic scoliosis that have been implanted with the Spinal Tethering System in an anterior vertebral body tethering construct.

The Spinal Tethering System

Intervention Type: DEVICE

An implant comprised of: vertebral body screws, vertebral body staples (washers), and a PET (polyethylene-terephthalate) cord.

Interventions

The Spinal Tethering System

An implant comprised of: vertebral body screws, vertebral body staples (washers), and a PET (polyethylene-terephthalate) cord.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients who assent/consent to participate in this study for prospective surveillance
• Patients at least 10 years old, inclusive, on the day of surgery
• Patients with idiopathic scoliosis
• Patient who has failed bracing (as defined by greater than 5° of progression and/or intolerance to brace wear)
• Patients who underwent an anterior vertebral body tethering procedure for treatment of scoliosis via thoracoscopic access or mini-thoracotomy
• Patients with a Lenke type 1 curve with lumbar modifier of A or B
• Patients whose pre-operative Cobb angle was ≥ 30° and ≤ 65°
• Patients whose pre-operative thoracic scoliometer reading is ≤ 20°
• Patients whose structural, thoracic curve bends out to ≤ 30° Cobb angle pre-operatively

• Ideally supine bending film
• Standing lateral bending film also acceptable
• Patients of Sanders stage ≤ 5 or Risser sign of ≤ 3 at the time of surgery
• Patients and parents that understand English

Exclusion Criteria

• Patients with vertebral body staples at any level of their spine

---Specifically, vertebral body staples that span an intervertebral disc space and are implanted for fusionless correction of scoliosis

• Patients with any spine surgery prior to their VBT procedure
• Patients with any deformity correction surgery, on their Lenke 1 curve, after their VBT procedure
• With the exception of tether re-tensioning
• Patients with any vertebral bodies that were instrumented outside of a thoracoscopic or minithoracotomy approach in conjunction with their VBT procedure
• Patients that have an orthotic prescribed and used to correct their Lenke 1 curve any time after their VBT procedure but before the 2 year primary endpoint
• Patients who are pregnant
• Patients unwilling to return for prospective follow-up visit(s)
• Patients with major psychiatric disorders (as defined in DSM-5)
• Patients with a history of substance abuse (as defined in DSM-5)
• Patients who are wards of the court
• Patients who are in an active drug or device trial that is more than minimal risk and where their participation in the trial would confound the measurements of the present study
• Patients who are in a device trial for efficacy of a musculoskeletal device and where their participation in the trial would confound the measurements of the present study
• Patients who are less than 30 days out from completion from another clinical trial of more than minimal risk or for safety and efficacy
• Patients for whom the investigator deems unwilling/incapable of participating

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 23 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amer Samdani, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospitals for Children - Philadelphia

Locations

Shriners Hospitals for Children

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

CSU2014-11S

Identifier Type: -

Identifier Source: org_study_id