SpineJack System Postmarket Registry

Study Overview
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Brief Summary
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This postmarket registry is intended to prospectively collect real world data to support ongoing safety and performance of the SpineJack system.

Detailed Description
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The SpineJack System Registry will employ a prospective, multicenter, observational, consecutive enrollment design. The sample size for this Registry will include at least 400 patients treated for VCFs across approximately 10 sites. A total of 240 patients will be treated with the SpineJack system and 160 patients will be treated with other vertebral augmentation (VA) procedures, such as BKP or VP. Sites within the U.S. may include healthcare professionals (HCPs) that are surgeons, pain physicians and/or interventional radiologists.

Official Title
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Prospective SpineJack System Registry

Conditions
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Osteoporotic Vertebral Compression Fractures

Intervention / Treatment
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* Procedure: SpineJack system
* Procedure: Balloon kyphoplasty
* Procedure: Vertebroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Understand and sign the informed consent form (as applicable) Exhibit no altered mental status or language barrier that may prevent completion of the patient reported outcome (PRO) surveys following the procedure. VCF diagnosis made and/or confirmed at participating site. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with SpineJack system<br>SpineJack system procedure | Procedure: SpineJack system<br>* For use in the reduction of painful osteoporotic vertebral compression fractures.<br>|
| Patients treated with vertebral augmentation<br>Vertebral augmentation procedures may include either balloon kyphoplasty (BKP) or vertebroplasty (VP). | Procedure: Balloon kyphoplasty<br>* Treatment of osteoporotic vertebral compression fractures.<br>Procedure: Vertebroplasty<br>* Treatment of osteoporotic vertebral compression fractures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back pain | The numeric rating scale consists of an eleven-point scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). | 12 months post-procedure | 
| Radiological outcomes | Vertebral body height restoration | Immeditely post-procedure | 
| Radiological outcomes | Adjacent level fractures | Immediately post-procedure | 
| Adverse events | Incidence of adverse device effects (ADEs) and serious adverse device effects (SADEs) requiring surgical re-intervention or re-treatment at the treated level Incidence of unanticipated ADEs Incidence of procedure-related AEs | 12 months post-procedure | 
| Quality of life indices | RMQD | 12 months post-procedure | 
| Quality of life indices | PROMIS Global-10 | 12 months post-procedure |