SpineJack System Postmarket Registry

Prospective SpineJack System Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04795765

Enrollment

261

Registered

2021-03-12

Start date

2019-08-19

Completion date

2024-11-11

Last updated

2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporotic Vertebral Compression Fractures

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 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.

Interventions

PROCEDURESpineJack system

For use in the reduction of painful osteoporotic vertebral compression fractures.

PROCEDUREBalloon kyphoplasty

Treatment of osteoporotic vertebral compression fractures.

PROCEDUREVertebroplasty

Treatment of osteoporotic vertebral compression fractures.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Back pain	12 months post-procedure	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).
Radiological outcomes	Immeditely post-procedure	Vertebral body height restoration
Adverse events	12 months post-procedure	1. Incidence of adverse device effects (ADEs) and serious adverse device effects (SADEs) requiring surgical re-intervention or re-treatment at the treated level 2. Incidence of unanticipated ADEs 3. Incidence of procedure-related AEs
Quality of life indices - Roland Morris Disability Questionnaire (RMDQ)	12 months post-procedure	24-item self-report questionnaire used in patients with mild to moderate disability due to acute, sub-acute or chronic low back pain
Patient-Reported Outcomes Measurement Information System (PROMIS Global-10)	12 months post-procedure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026