SpineJack System Postmarket Registry
- Conditions
- Osteoporotic Vertebral Compression Fractures
- Interventions
- Procedure: SpineJack systemProcedure: Balloon kyphoplastyProcedure: Vertebroplasty
- Registration Number
- NCT04795765
- Lead Sponsor
- Stryker Instruments
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
- 18 years of age or older
- Understand and sign the informed consent form (as applicable)
- Exhibit no altered mental status or language barrier that may prevent completion of the patient reported outcome (PRO) surveys following the procedure.
- VCF diagnosis made and/or confirmed at participating site.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients treated with SpineJack system SpineJack system SpineJack system procedure Patients treated with vertebral augmentation Vertebroplasty Vertebral augmentation procedures may include either balloon kyphoplasty (BKP) or vertebroplasty (VP). Patients treated with vertebral augmentation Balloon kyphoplasty Vertebral augmentation procedures may include either balloon kyphoplasty (BKP) or vertebroplasty (VP).
- Primary Outcome Measures
Name Time Method 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 Immediately post-procedure Adjacent level fractures
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 AEsQuality 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
San Diego Neurosurgery
🇺🇸Encinitas, California, United States
California Orthopedics and Spine
🇺🇸Larkspur, California, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Dartmouth Hitchcock
🇺🇸Lebanon, New Hampshire, United States
Cleveland Clinic
🇺🇸Stuart, Florida, United States
Clinical Investigations
🇺🇸Edmond, Oklahoma, United States
Center for Diagnostic Imaging (CDI)
🇺🇸Puyallup, Washington, United States
Rainier Orthopedic Institute
🇺🇸Puyallup, Washington, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
St. Luke's IntermountainResearch Center
🇺🇸Boise, Idaho, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States