Clinical trial NCT04795765: SpineJack System Postmarket Registry
Official title: Prospective SpineJack System Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporotic Vertebral Compression Fractures
Lead sponsor: Stryker Instruments
Sponsor class: INDUSTRY
Collaborators: name: Talosix
First posted: 2021-03-12
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients that meet inclusion criteria.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Back pain
timeFrame: 12 months post-procedure
measure: Radiological outcomes
timeFrame: Immeditely post-procedure
measure: Radiological outcomes
timeFrame: Immediately post-procedure
measure: Adverse events
timeFrame: 12 months post-procedure
measure: Quality of life indices - Roland Morris Disability Questionnaire (RMDQ)
timeFrame: 12 months post-procedure
measure: Patient-Reported Outcomes Measurement Information System (PROMIS Global-10)
timeFrame: 12 months post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: San Diego Neurosurgery
state: California
city: Larkspur
country: United States
facility: California Orthopedics and Spine
state: California
city: Stuart
country: United States
facility: Cleveland Clinic
state: Florida
city: Boise
country: United States
facility: St. Luke's IntermountainResearch Center
state: Idaho
city: Lebanon
country: United States
facility: Dartmouth Hitchcock
state: New Hampshire
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Edmond
country: United States
facility: Clinical Investigations
state: Oklahoma
city: Puyallup
country: United States
facility: Center for Diagnostic Imaging (CDI)
state: Washington
city: Puyallup
country: United States
facility: Rainier Orthopedic Institute
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: