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| General |
| Study Status |
Study Pending |
| 522 Number / Requirement Number |
PS260001 / PSS001 |
| Date Original Plan Accepted |
05/14/2026
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| Date Current Plan Accepted |
05/14/2026
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| Study Name |
VerteGlide Spinal Growth Guidance System 522 Study
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| Device Name |
Verteglide spinal growth guidance system
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| Root Document Number |
K241816
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
External Registry
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Infant: 29 days < 2 yrs,
Child: 2 yrs < 12 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of the postmarket surveillance study is to characterize the long-term safety profile of the VerteGlide system by specifically focusing on Adverse Local Tissue Reactions (ALTRs) and the rate of subsequent surgical interventions in relation to Cobalt (Co) and Chromium (Cr) wear debris in pediatric subjects with Early Onset Scoliosis (EOS) through 60 months post-implantation or study exit.
The postmarket surveillance study will be a prospective, multicenter, observational clinical surveillance study to assess the long-term safety and performance of the VerteGlide Spinal Growth Guidance System in a pediatric population with EOS. The study cohort requires mandatory intraoperative baseline serum metal ion levels and standardized follow-up to address specific FDA Public Health Questions regarding systemic metal exposure and subsequent surgical interventions. The cohort will be divided into two sub-cohorts.
3. Asymptomatic Post-Operative Cohort
4. Subsequent Surgical Intervention (planned or unplanned)
During the study’s lifecycle, some patients are expected to cross from the Asymptomatic Post-Operative Cohort to the Subsequent Surgical Interventions cohort due to planned or unplanned events.
Informed consent will be obtained from the patient’s parent(s)/legal guardian(s), with assent from the patient as appropriate, before any study-specific procedures are performed.
The study design is intended to follow the standard of care for EOS patients to minimize burden on patients and their families and reduce the risk of loss to follow-up.
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| Study Population |
The VerteGlide Spinal Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome for the following subset of patients:
• Patients who may require serial magnetic resonance imaging;
• Patients with small stature;
• Patients with low body weight, compromised tissue coverage adjacent to spinal implants, or increased risk of implant associated wound healing adverse events;
• Patients at risk for implant prominence following surgery;
• Patients with hyperkyphotic spinal deformities; OR.
• Patients at elevated risk of cardiac arrest/sudden death from anesthesia associated with additional spinal surgery.
Inclusion Criteria:
5. Diagnosis of EOS and treatment with the VerteGlide system in accordance with the cleared indications for use.
6. Subject was less than 10 years of age at the date of the index (initial) surgery.
7. Written informed consent obtained from a legally authorized representative (and subject assent, as applicable).
8. Subject and/or representative demonstrate and understanding of the study requirements and a willingness to comply with all scheduled follow-up procedures (e.g., radiographic assessments and serum metal ion draws).
Exclusion Criteria:
14. Document or suspected material allergy or intolerance, specifically to Ti-6Al-4V, titanium, and cobalt.
15. A metal implant (or metal component) in situ.
16. Known inadequate bone strength for secure device fixation.
17. Active systemic infection or infection localized to the intended implant site.
18. Any active systemic disease (including malignancy) that, in the opinion of the Investigator, would compromise the subject’s welfare or the overall integrity and outcome of the study.
19. Inadequate soft tissue coverage over the operative site.
20. Any case where the implant components selected for use would be too large or too small to achieve a successful result.
21. Any patient in which implant utilization would interfere with anatomical structure or expected physiologic performance.
22. Presence of any condition that produces loads on the device that could lead to failure (e.g., obesity).
23. Spinal cord abnormalities that require treatment.
24. Absent diaphragmatic function.
25. Previous spine surgery that would prevent the successful performance of the VerteGlide system.
26. Inability or unwillingness to follow a post-operative regimen or scheduled study procedures.
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| Sample Size |
Number of subjects: 20 subjects
Assumptions for sample size estimation: N/A
Number of sites: Minimum of 2
Sites location: TBD- The study is planned to be performed at high-volume pediatric spine centers in the US that routinely manage children with EOS. Sites will typically be tertiary or quaternary care children’s hospitals with established orthopediatric or spine surgery programs and experience with growth-friendly instrumentation. Investigators who use or intend to use the VerteGlide system will be asked to join the study and recruit from their patient population.
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| Key Study Endpoints |
Safety Endpoints
Primary: The primary safety endpoint is a descriptive characterization of the adverse event (AE) profile and subsequent surgical intervention rate through 5 years post-procedure or 6 months post conversion.
Evaluation includes:
• AE Profile: The number and proportion of patients experiencing AEs/SAEs, classified by seriousness, severity, and relationship to the device or procedure.
• Local Safety Signs: Rate of Adverse Local Tissue Reactions (ALTRs) and associated clinical findings (e.g., focal neurological changes, local nerve palsy, palpable masses, local swelling or effusion, skin penetration or irritation, implant-host bond loosening, osteolysis (bone loss), or migration of the implant). Additional inflammatory indicators include localized tissue necrosis or the presence of pseudotumors.
• Subsequent surgical intervention rate: The number and proportion of patients requiring secondary surgical interventions, classified as revision, removals, reoperations, or supplemental fixations.
Secondary:
3. Metal Ion Levels: Descriptive characterization of systemic Co and Cr levels obtained via intraoperative venipuncture at baseline (initial implantation) and at any subsequent SSI (planned or unplanned).
4. A descriptive exploration of whether the risk of identified AEs, SAEs, and SSIs are associated with the presences of CoCr wear debris.
• Histology and Pathological Analysis: For subjects in the SSI cohort, this is performed via intraoperative histology of the implant wound bed (including ALVAL scoring), routine surveillance microbiology, and immunology to identify intracellular vs. extracellular debris.
• Explant Analysis: For removed hardware, evaluation includes photomicrographs, spectroscopy, and microscopy for particle size distribution (micro vs. nanoscale).
Effectiveness Endpoints
Primary: N/A
Secondary:
4. Spinal Growth Maintenance: Mean change in T1-T12 and T1-S1 height as measured on standard-of-care radiographs obtained annually through 5 years.
5. Deformity Correction: Change in the Cobb angle of the primary curve as measured on standard-of-care radiographs obtained annually through 5 years.
6. Health-related quality of life: Mean EOSQ-24 total score, calculated according to the instrument scoring manual and obtained annually through 5 years.
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| Follow-up Visits and Length of Follow-up |
Follow-up visits are at 6 weeks, 6 months, 12 months, and annually thereafter for 5 years (60 months), or for 6 months post-conversion to posterior spinal fusion surgery.
Preoperative Baseline: Within 3 months prior to the index surgery
Perioperative Baseline (Index Surgery): Intraoperative findings and baseline serology (intraoperative venipuncture only)
Immediate Postoperative: 6 weeks (±2 weeks) from surgery
6-Month Follow-up: 6 months (± 2 months) post-index surgery
Annual Follow-up: Annually (±3 months) thereafter for up to 5 years
End of Study/Conversion: Subject end of study will be reached either at the 60-month follow-up milestone or the 6-month post: 1) Fusion surgery, or 2) The point of conversion of the study device to an alternative treatment/permanent hardware removal.
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