Retrospective Review With Prospective Surveillance of Safety and Efficacy in a Clinical Series of Spinal Tethering Patients

Zimmer Biomet1 site in 1 country56 target enrollmentJuly 6, 2016

ConditionsAdolescent Idiopathic Scoliosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Adolescent Idiopathic Scoliosis
Sponsor: Zimmer Biomet
Enrollment: 56
Locations: 1
Primary Endpoint: Quantification and timing of all adverse events
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 6, 2016

End Date

October 2022

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

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

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)

Outcomes

Primary Outcomes

Quantification and timing of all adverse events

Time Frame: Up to 18 years of age or skeletal maturity is reached

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

Cobb angle measurement of the patient's coronal deformity

Time Frame: 2 Years post Index Vertebral Body Tethering Surgery

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

Secondary Outcomes

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 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 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.)
Longitudinal changes in coronal Cobb angle.(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 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 sagittal 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.)
Longitudinal changes in thoracic spine height.(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.)