Clinical trial NCT02897453: Safety and Efficacy Study of Spinal Tethering
Official title: Retrospective Review With Prospective Surveillance of Safety and Efficacy in a Clinical Series of Spinal Tethering Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2016-09-13
Enrollment: 56
Sex: ALL
Minimum age (years): 10
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are individuals with idiopathic scoliosis who received surgical treatment utilizing a spinal tethering technique

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.

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

Primary outcomes:
measure: Cobb angle measurement of the patient's coronal deformity
timeFrame: 2 Years post Index Vertebral Body Tethering Surgery
measure: Quantification and timing of all adverse events
timeFrame: Up to 18 years of age or skeletal maturity is reached
Secondary outcomes:
measure: Longitudinal changes in PedsQL (as available)
timeFrame: 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.
measure: Longitudinal changes in APPT (as available)
timeFrame: 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.
measure: Longitudinal changes in SRS-22 (as available)
timeFrame: 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.
measure: Longitudinal changes in thoracic kyphosis.
timeFrame: 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.
measure: Longitudinal changes in coronal balance
timeFrame: 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.
measure: Longitudinal changes in sagittal balance.
timeFrame: 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.
measure: Longitudinal changes in coronal Cobb angle.
timeFrame: 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.
measure: Longitudinal changes in thoracic spine height.
timeFrame: 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.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Shriners Hospitals for Children
state: Pennsylvania
Study officials:
affiliation: Shriners Hospitals for Children - Philadelphia
name: Amer Samdani, MD
role: PRINCIPAL_INVESTIGATOR
References: