Status:
COMPLETED
SpineJack System Postmarket Registry
Lead Sponsor:
Stryker Instruments
Collaborating Sponsors:
Talosix
Conditions:
Osteoporotic Vertebral Compression Fractures
Eligibility:
All Genders
18+ years
Brief Summary
This postmarket registry is intended to prospectively collect real world data to support ongoing safety and performance of the SpineJack system.
Detailed 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 VCF...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
August 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 11 2024
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT04795765
Start Date
August 19 2019
End Date
November 11 2024
Last Update
December 10 2024
Active Locations (12)
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1
San Diego Neurosurgery
Encinitas, California, United States, 92024
2
California Orthopedics and Spine
Larkspur, California, United States, 94939
3
Cleveland Clinic
Stuart, Florida, United States, 34994
4
St. Luke's IntermountainResearch Center
Boise, Idaho, United States, 83702