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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (12 locations)

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