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Completed

NCT Number: NCT04795765

SpineJack System Postmarket Registry

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

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Key information

Conditions

Osteoporotic Vertebral Compression Fractures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Diego Neurosurgery, Encinitas, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

SpineJack system

Procedure

For use in the reduction of painful osteoporotic vertebral compression fractures.

balloon kyphoplasty

Procedure

Treatment of osteoporotic vertebral compression fractures.

vertebroplasty

Procedure

Treatment of osteoporotic vertebral compression fractures.

Primary outcomes

  1. Back pain

    Time frame: 12 months post-procedure

    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).

  2. Radiological outcomes

    Time frame: Immeditely post-procedure

    Vertebral body height restoration

  3. Radiological outcomes

    Time frame: Immediately post-procedure

    Adjacent level fractures

  4. Adverse events

    Time frame: 12 months post-procedure

    • 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

  5. Quality of life indices - Roland Morris Disability Questionnaire (RMDQ)

    Time frame: 12 months post-procedure

    24-item self-report questionnaire used in patients with mild to moderate disability due to acute, sub-acute or chronic low back pain

  6. Patient-Reported Outcomes Measurement Information System (PROMIS Global-10)

    Time frame: 12 months post-procedure

    10-item questionnaire that is used to assess general domains of health and functioning, including overall physical health, mental health, social health, pain, fatigue and overall perceived quality of life

Sponsors and collaborators

Lead sponsor

Stryker Instruments

Industry

Collaborators

  • Talosix

Registry information

Official study title

Prospective SpineJack System Registry

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2021
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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