Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT04007094
Eligibility Criteria:
Inclusion Criteria:
* Subject is scheduled to undergo a single or multilevel posterolateral spinal fusion surgery using ViviGen Cellular Bone matrix
* Subject must be over the age of 18 years old
* Subject has been unresponsive to conservative care for a minimum of 6 months.
* The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
Exclusion Criteria:
* Subjects requiring additional bone grafting materials other than local autograft and ViviGen Cellular Bone Matrix will be excluded from this outcomes study.
* Subject has inadequate tissue coverage over the operative site
* Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
* Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
* Subject has an active local or systemic infection.
* Subject has a metal sensitivity/foreign body sensitivity.
* Subject is morbidly obese, defined as a body mass index (BMI) greater than 45.
* Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
* Subject is currently involved in another investigational drug or device study that could confound study data.
* Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
* Subjects who are pregnant or plan to become pregnant in the next 24 months or who are lactating.
* Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain.
* Osteoporosis (per the investigator's diagnosis or per a T-score \> 2.5 standard deviations below the mean for a young, healthy adult) that may prevent adequate fixation of screws and thus preclude the use of a pedicle screw system.
* Subjects who have a known or suspected allergy to any of the following antibiotics and/or reagents: Gentamicin Sulfate, Meropenem, Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin (HSA);
* Immune compromised subjects
* Known sensitivity to device materials
* Subject is a prisoner.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04007094
Study Brief:
Protocol Section:
NCT04007094