Adolescent Idiopathic ScoliosisNCT02897453
Safety and Efficacy Study of Spinal Tethering
An observational study of Adolescent Idiopathic Scoliosis, run by Zimmer Biomet at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- The Spinal Tethering System
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2016to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants are individuals with idiopathic scoliosis who received surgical treatment utilizing a spinal tethering technique
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children
Philadelphia, Pennsylvania, 19140
About this study
Official title: Retrospective Review With Prospective Surveillance of Safety and Efficacy in a Clinical Series of Spinal Tethering Patients
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).
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- The Spinal Tethering System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Spinal Tethering SystemDevice
An implant comprised of: vertebral body screws, vertebral body staples (washers), and a PET (polyethylene-terephthalate) cord.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: The Spinal Tethering System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angle measurement of the patient's coronal deformity
Coronal Cobb angle at 24 month follow up after vertebral body tethering
Measured: 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.
Measured: Up to 18 years of age or skeletal maturity is reached
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start6 Jul 2016
- Primary completion19 Jul 2020
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amer Samdani, MD, Principal investigator, Shriners Hospitals for Children - Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897453
- Sponsor's protocol ID
- CSU2014-11S
- Status last verified
- Feb 2020
- First submitted
- 14 Jul 2016
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review With Prospective Surveillance of Safety and Efficacy in a Clinical Series of Spinal Tethering Patients
- ClinicalTrials.gov ID
- NCT02897453
- Acronym / sponsor ID
- CSU2014-11S
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2016 (actual)
- Primary completion
- 19 Jul 2020 (actual)
- Study completion
- Oct 2022 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Spinal Tethering System group | – | Device: The Spinal Tethering SystemPatients with adolescent idiopathic scoliosis that have been implanted with the Spinal Tethering System in an anterior vertebral body tethering construct. |
Who may qualify
- Ages
- 10 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants are individuals with idiopathic scoliosis who received surgical treatment utilizing a spinal tethering technique
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Spinal Tethering SystemAn implant comprised of: vertebral body screws, vertebral body staples (washers), and a PET (polyethylene-terephthalate) cord. | Device | The Spinal Tethering System group |
Primary outcome
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
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.
8 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amer Samdani, MD principal investigator
Shriners Hospitals for Children - Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis, run by Zimmer Biomet at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb angle measurement of the patient's coronal deformity (time frame: 2 Years post Index Vertebral Body Tethering Surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.