Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
261 participants
OBSERVATIONAL
2019-08-19
2024-11-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients treated with SpineJack system
SpineJack system procedure
SpineJack system
For use in the reduction of painful osteoporotic vertebral compression fractures.
Patients treated with vertebral augmentation
Vertebral augmentation procedures may include either balloon kyphoplasty (BKP) or vertebroplasty (VP).
Balloon kyphoplasty
Treatment of osteoporotic vertebral compression fractures.
Vertebroplasty
Treatment of osteoporotic vertebral compression fractures.
Interventions
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SpineJack system
For use in the reduction of painful osteoporotic vertebral compression fractures.
Balloon kyphoplasty
Treatment of osteoporotic vertebral compression fractures.
Vertebroplasty
Treatment of osteoporotic vertebral compression fractures.
Eligibility Criteria
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Inclusion Criteria
2. Understand and sign the informed consent form (as applicable)
3. Exhibit no altered mental status or language barrier that may prevent completion of the patient reported outcome (PRO) surveys following the procedure.
4. VCF diagnosis made and/or confirmed at participating site.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Talosix
UNKNOWN
Stryker Instruments
INDUSTRY
Responsible Party
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Locations
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San Diego Neurosurgery
Encinitas, California, United States
California Orthopedics and Spine
Larkspur, California, United States
Cleveland Clinic
Stuart, Florida, United States
St. Luke's IntermountainResearch Center
Boise, Idaho, United States
Dartmouth Hitchcock
Lebanon, New Hampshire, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Clinical Investigations
Edmond, Oklahoma, United States
Center for Diagnostic Imaging (CDI)
Puyallup, Washington, United States
Rainier Orthopedic Institute
Puyallup, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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SISSJS2019US
Identifier Type: -
Identifier Source: org_study_id