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Safety and Efficacy Study of Spinal Tethering

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ClinicalTrials.gov Identifier: NCT02897453
Recruitment Status : Active, not recruiting
First Posted : September 13, 2016
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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).

Condition or disease Intervention/treatment
Adolescent Idiopathic Scoliosis Device: The Spinal Tethering System

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 or skeletal maturity (whichever is longer). Over the course of their follow-up clinical outcomes, patient reported outcomes, and radiographic outcomes will be tracked.

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Retrospective Review With Prospective Surveillance of Safety and Efficacy in a Clinical Series of Spinal Tethering Patients
Actual Study Start Date : July 6, 2016
Actual Primary Completion Date : April 9, 2019
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

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




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Longitudinal changes in PedsQL (as available) [ Time Frame: 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. ]
    All prospective visits will capture the standard core scale of the PedsQL. This patient reported outcome is not standard of care therefore only prospective visits will capture the assessment.

  2. Longitudinal changes in APPT (as available) [ Time Frame: 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. ]
    All prospective visits will capture the APPT (adolescent pediatric pain tool) score. This patient reported outcome is not standard of care therefore only prospective visits will capture the assessment.

  3. Longitudinal changes in SRS-22 (as available) [ Time Frame: 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. ]
    All prospective visits will capture the SRS-22 (Scoliosis Research Society 22 item patient questionnaire) score. This patient reported outcome is not standard of care therefore only prospective visits will capture the assessment.

  4. Longitudinal changes in thoracic kyphosis. [ Time Frame: 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. ]
  5. Longitudinal changes in coronal balance [ Time Frame: 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. ]
  6. Longitudinal changes in sagittal balance. [ Time Frame: 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. ]
  7. Longitudinal changes in coronal Cobb angle. [ Time Frame: 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. ]
    In addition to the primary endpoint finding at 2 years post index surgery, this measure will assess durability of the coronal Cobb angle through skeletal maturity.

  8. Longitudinal changes in thoracic spine height. [ Time Frame: 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. ]
    Capture of total vertical thoracic spine height at every post-surgical follow up until the patient is 18 years old or skeletally mature.



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Ages Eligible for Study:   10 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants are individuals with idiopathic scoliosis who received surgical treatment utilizing a spinal tethering technique
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897453


Locations
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United States, Pennsylvania
Shriners Hospitals for Children
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: Amer Samdani, MD Shriners Hospitals for Children - Philadelphia

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02897453     History of Changes
Other Study ID Numbers: CSU2014‐11S
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases