Evaluation of Fusion Rate Using K2M VESUVIUS® Demineralized Fibers With K2M EVEREST® Spinal System

K2M

Status: Terminated

Conditions: Degenerative Disc Disease; Spondylolisthesis; Spinal Stenosis

Study type: Observational

Funder types: Industry

Identifiers

NCT02064855

CA-003

Details and patient eligibility

About

The purpose of this study is to evaluate fusion status and patient outcomes observed from use of the VESUVIUS Demineralized Fibers with the EVEREST Spinal System as compared to the literature reported outcomes of spinal fusion using autograft with posterior stabilization.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of non-cervical spinal stenosis; spondylolisthesis (grade 1 or 2); and/or degenerative disc disease (DDD) with one or two contiguous levels requiring surgical intervention between L1-S1. Qualified patients will be confirmed for inclusion by patient history and radiographic studies
• Willing and able to comply with the requirements of the protocol including follow-up requirements
• Willing and able to sign a study specific informed consent
• Skeletally mature and I 18 years old at time of enrollment

Exclusion criteria

• Previous spine surgery at the index level
• Previous posterior spine surgery (e.g., posterior decompression) that destabilizes the lumbar spine
• Active systemic infection or infection at the operative site
• Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment
• Metabolic bone disease such as osteoporosis and osteopenia that contradicts spinal surgery
• History of an osteoporotic fracture
• History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
• Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
• Known allergy to titanium or cobalt chrome
• Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C, or fibromyalgia
• Insulin-dependent type 1 or type 2 diabetes
• Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
• Pregnant, or intends to become pregnant, during the course of the study
• Severe obesity (Body Mass Index > 40)
• Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain, or quality of life.
• Involved in current or pending spinal litigation where permanent disability benefits are being sought
• Incarcerated at the time of study enrollment
• Current participation in an investigational study that may impact study outcomes

Trial design