Safety and Efficacy Study of Spinal Tethering

NCT02897453 | Unknown DMC

• 1 other identifier: CSU2014-11S
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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).

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (2)

• Cobb angle measurement of the patient's coronal deformity

  Coronal Cobb angle at 24 month follow up after vertebral body tethering

  2 Years post Index Vertebral Body Tethering Surgery

• Quantification and timing of all adverse events

  Patients will be followed until skeletal maturity or 18 years old; whichever is longer.

  Up to 18 years of age or skeletal maturity is reached

Secondary Outcomes (8)

• Longitudinal changes in PedsQL (as available)

  Yearly up to 2 years post index surgery. Biannually after 2 year post index surgery. Collected until patient is 18 or skeletally mature, whichever is longer.

• Longitudinal changes in APPT (as available)

  Yearly up to 2 years post index surgery. Biannually after 2 year post index surgery. Collected until patient is 18 or skeletally mature, whichever is longer.

• Longitudinal changes in SRS-22 (as available)

  Yearly up to 2 years post index surgery. Biannually after 2 year post index surgery. Collected until patient is 18 or skeletally mature, whichever is longer.

• Longitudinal changes in thoracic kyphosis.

  Yearly up to 2 years post index surgery. Biannually after 2 year post index surgery. Collected until patient is 18 or skeletally mature, whichever is longer.

• Longitudinal changes in coronal balance

  Yearly up to 2 years post index surgery. Biannually after 2 year post index surgery. Collected until patient is 18 or skeletally mature, whichever is longer.

Study Arms (1)

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.

Device: The Spinal Tethering System

Interventions

The Spinal Tethering System DEVICE

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

The Spinal Tethering System group

Eligibility Criteria

• Age: 10 Years - 23 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants are individuals with idiopathic scoliosis who received surgical treatment utilizing a spinal tethering technique

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Shriners Hospitals for Children

Philadelphia, Pennsylvania, 19140, United States

Location

Study Officials

• Amer Samdani, MD

  Shriners Hospitals for Children - Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: September 13, 2016
• Study Start: July 6, 2016
• Primary Completion: July 19, 2020
• Study Completion: October 1, 2022
• Last Updated: August 20, 2020

Record last verified: 2020-02

Locations

US (1)