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).
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.
Study Type
OBSERVATIONAL
Enrollment
56
An implant comprised of: vertebral body screws, vertebral body staples (washers), and a PET (polyethylene-terephthalate) cord.
Shriners Hospitals for Children
Philadelphia, Pennsylvania, United States
Cobb angle measurement of the patient's coronal deformity
Coronal Cobb angle at 24 month follow up after vertebral body tethering
Time frame: 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.
Time frame: Up to 18 years of age or skeletal maturity is reached
Longitudinal changes in PedsQL (as available)
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.
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.
Longitudinal changes in APPT (as available)
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.
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.
Longitudinal changes in SRS-22 (as available)
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.
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
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.
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.
Longitudinal changes in coronal Cobb angle.
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.
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.
Longitudinal changes in thoracic spine height.
Capture of total vertical thoracic spine height at every post-surgical follow up until the patient is 18 years old or skeletally mature.
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.