SpineJack System Postmarket Registry

Last updated: December 5, 2024
Sponsor: Stryker Instruments
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Balloon kyphoplasty

Vertebroplasty

SpineJack system

Clinical Study ID

NCT04795765
SISSJS2019US
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years of age or older

  2. Understand and sign the informed consent form (as applicable)

  3. Exhibit no altered mental status or language barrier that may prevent completion ofthe patient reported outcome (PRO) surveys following the procedure.

  4. VCF diagnosis made and/or confirmed at participating site.

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 261
Treatment Group(s): 3
Primary Treatment: Balloon kyphoplasty
Phase:
Study Start date:
August 19, 2019
Estimated Completion Date:
November 11, 2024

Study Description

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.

Connect with a study center

  • San Diego Neurosurgery

    Encinitas, California 92024
    United States

    Site Not Available

  • California Orthopedics and Spine

    Larkspur, California 94939
    United States

    Site Not Available

  • San Diego Neurosurgery

    San Diego, California 92037
    United States

    Site Not Available

  • Cleveland Clinic

    Stuart, Florida 34994
    United States

    Site Not Available

  • St. Luke's IntermountainResearch Center

    Boise, Idaho 83702
    United States

    Site Not Available

  • Dartmouth Hitchcock

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Clinical Investigations

    Edmond, Oklahoma 73013
    United States

    Site Not Available

  • Center for Diagnostic Imaging

    Federal Way, Washington 98003
    United States

    Site Not Available

  • Center for Diagnostic Imaging (CDI)

    Puyallup, Washington 98373
    United States

    Site Not Available

  • Rainier Orthopedic Institute

    Puyallup, Washington 98374
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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