SpineJack System Postmarket Registry

Prospective SpineJack System Registry

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

Study Overview

• Status: Completed
• Conditions: Osteoporotic Vertebral Compression Fractures
• Intervention / Treatment: 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 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.

• Study Type: Observational
• Enrollment (Actual): 261

Contacts and Locations

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • San Diego Neurosurgery
    • Larkspur, California, United States, 94939
      • California Orthopedics and Spine
  • Florida
    • Stuart, Florida, United States, 34994
      • Cleveland Clinic
  • Idaho
    • Boise, Idaho, United States, 83702
      • St. Luke's IntermountainResearch Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Clinical Investigations
  • Washington
    • Puyallup, Washington, United States, 98373
      • Center for Diagnostic Imaging (CDI)
    • Puyallup, Washington, United States, 98374
      • Rainier Orthopedic Institute
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All eligible patients that meet inclusion criteria.

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Radiological outcomes	Vertebral body height restoration	Immeditely post-procedure
Radiological outcomes	Adjacent level fractures	Immediately post-procedure
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
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
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

Collaborators and Investigators

• Sponsor: Stryker Instruments
• Collaborators: Talosix

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2019
• Primary Completion (Actual): November 11, 2024
• Study Completion (Actual): November 11, 2024

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Compression
• Other Study ID Numbers: SISSJS2019US

Drug and device information, study documents

• 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