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SpineJack System Postmarket Registry

Sponsor
Stryker Instruments (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04795765
Collaborator
Talosix (Other)
500
Enrollment
8
Locations
51.4
Anticipated Duration (Months)
62.5
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: SpineJack system
  • Procedure: Balloon kyphoplasty
  • Procedure: Vertebroplasty

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 500 patients treated for VCFs across approximately 10 sites. A total of 300 patients will be treated with the SpineJack system and 200 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective SpineJack System Registry
Actual Study Start Date :
Aug 19, 2019
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients treated with SpineJack system

SpineJack system procedure

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).

Procedure: Balloon kyphoplasty
Treatment of osteoporotic vertebral compression fractures.

Procedure: Vertebroplasty
Treatment of osteoporotic vertebral compression fractures.

Outcome Measures

Primary Outcome Measures

  1. Back pain [12 months]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 of the patient reported outcome (PRO) surveys following the procedure.

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

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Diego Neurosurgery San Diego California United States 92037
2 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03766
3 Montefiore Medical Center Bronx New York United States 10467
4 Mount Sinai Hospital New York New York United States 10029
5 Summit Medical Center Edmond Oklahoma United States 73013
6 Center for Diagnostic Imaging Federal Way Washington United States 98003
7 Rainier Orthopedic Institute Puyallup Washington United States 98374
8 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • Stryker Instruments
  • Talosix

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stryker Instruments
ClinicalTrials.gov Identifier:
NCT04795765
Other Study ID Numbers:
  • SISSJS2019US
First Posted:
Mar 12, 2021
Last Update Posted:
Oct 5, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Fractures, Compression

Study Results

No Results Posted as of Oct 5, 2021