An observational study in Osteoporotic Vertebral Compression Fractures, sponsored by Stryker Instruments. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by Stryker Instruments (part of Stryker) · Observational
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.
50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.
This study's enrollment of 261 is above the median of 100 across 16 observational studies indexed under Fractures, Compression.
Browse Fractures, Compression studies →Stryker Instruments is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All eligible patients that meet inclusion criteria.
Exclusion Criteria:
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SpineJack system procedure
Procedure: SpineJack system
Vertebral augmentation procedures may include either balloon kyphoplasty (BKP) or vertebroplasty (VP).
Procedure: Balloon kyphoplasty · Procedure: Vertebroplasty
For use in the reduction of painful osteoporotic vertebral compression fractures.
Treatment of osteoporotic vertebral compression fractures.
Treatment of osteoporotic vertebral compression fractures.
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
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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