SpineJack System Postmarket Registry

Osteoporotic Vertebral Compression Fractures Clinical Trial

Official title:

Prospective SpineJack System Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04795765
• Other study ID #: SISSJS2019US
• Status: Active, not recruiting
• Start date: August 19, 2019
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Stryker Instruments
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Fractures, Compression
• Osteoporotic Vertebral Compression Fractures

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	St. Luke's IntermountainResearch Center	Boise	Idaho
United States	Montefiore Medical Center	Bronx	New York
United States	Clinical Investigations	Edmond	Oklahoma
United States	San Diego Neurosurgery	Encinitas	California
United States	California Orthopedics and Spine	Larkspur	California
United States	Dartmouth Hitchcock	Lebanon	New Hampshire
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Center for Diagnostic Imaging (CDI)	Puyallup	Washington
United States	Rainier Orthopedic Institute	Puyallup	Washington
United States	Cleveland Clinic	Stuart	Florida
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Stryker Instruments	Talosix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Back pain	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).	12 months post-procedure
Primary	Radiological outcomes	Vertebral body height restoration	Immeditely post-procedure
Primary	Radiological outcomes	Adjacent level fractures	Immediately post-procedure
Primary	Adverse events	Incidence of adverse device effects (ADEs) and serious adverse device effects (SADEs) requiring surgical re-intervention or re-treatment at the treated level; Incidence of unanticipated ADEs; Incidence of procedure-related AEs	12 months post-procedure
Primary	Quality of life indices - Roland Morris Disability Questionnaire (RMDQ)	24-item self-report questionnaire used in patients with mild to moderate disability due to acute, sub-acute or chronic low back pain	12 months post-procedure
Primary	Patient-Reported Outcomes Measurement Information System (PROMIS Global-10)	10-item questionnaire that is used to assess general domains of health and functioning, including overall physical health, mental health, social health, pain, fatigue and overall perceived quality of life	12 months post-procedure