SpineJack System Postmarket Registry

Stryker Instruments261 enrolled

Overview

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

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

261

Conditions

Osteoporotic Vertebral Compression Fractures

Interventions

SpineJack systemPROCEDURE

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

Balloon kyphoplastyPROCEDURE

Treatment of osteoporotic vertebral compression fractures.

VertebroplastyPROCEDURE

Treatment of osteoporotic vertebral compression fractures.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: \-

Locations (12)

San Diego Neurosurgery

Encinitas, California, United States

California Orthopedics and Spine

Larkspur, California, United States

Cleveland Clinic

Stuart, Florida, United States

Outcomes

Primary Outcomes

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).

Time frame: 12 months post-procedure

Radiological outcomes

Vertebral body height restoration

Time frame: Immeditely post-procedure

Radiological outcomes

Adjacent level fractures

Time frame: Immediately post-procedure

Adverse events

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

Time frame: 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

Time frame: 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

Time frame: 12 months post-procedure

Data from ClinicalTrials.gov

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