Clinical trial NCT02064855: Evaluation of Fusion Rate Using K2M VESUVIUS® Demineralized Fibers With K2M EVEREST® Spinal System
Official title: The Fusion Rate With K2M VESUVIUS® Demineralized Fibers Used With K2M EVEREST® Spinal System Compared to Autologous Bone Graft With Posterior Stabilization
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spinal Stenosis
Spondylolisthesis
Degenerative Disc Disease
Keywords: Spinal stenosis
Spondylolisthesis
Degenerative disc disease
Spinal fusion
Allograft
Interbody fusion
Lead sponsor: K2M, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-17
Enrollment: 108
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: Subjects will be identified from the surgeon's practice.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 24 months
measure: Fusion Status on CT at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Radiographic Assessments
timeFrame: 12m
measure: Radiographic Assessments
timeFrame: 12 Months and 24 Months
measure: Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI)
timeFrame: Baseline (Pre-Op), 24 months
measure: Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months
timeFrame: Baseline (up to 8 weeks post-operatively) to 24 months
measure: Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months
timeFrame: Baseline (up to 8 weeks post-operatively) to 24 months
measure: Patient Satisfaction
timeFrame: 12 months, 24 months
measure: Length of Surgery Time
timeFrame: At time of surgery
measure: Length of Anesthesia Time
timeFrame: At time of surgery
measure: Estimated Blood Loss
timeFrame: At time of surgery
measure: Length of Hospital Stay
timeFrame: Admission to discharge
measure: Time to Return to Work/School
timeFrame: Pre-Op to 24 months
measure: Use of Narcotics Post-surgery
timeFrame: Pre-Op to 24 months
Other outcomes:
Locations:
Study officials:
References:
citation: Cammisa FP Jr, Lowery G, Garfin SR, Geisler FH, Klara PM, McGuire RA, Sassard WR, Stubbs H, Block JE. Two-year fusion rate equivalency between Grafton DBM gel and autograft in posterolateral spine fusion: a prospective controlled trial employing a side-by-side comparison in the same patient. Spine (Phila Pa 1976). 2004 Mar 15;29(6):660-6. doi: 10.1097/01.brs.0000116588.17129.b9.
citation: Chen WJ, Tsai TT, Chen LH, Niu CC, Lai PL, Fu TS, McCarthy K. The fusion rate of calcium sulfate with local autograft bone compared with autologous iliac bone graft for instrumented short-segment spinal fusion. Spine (Phila Pa 1976). 2005 Oct 15;30(20):2293-7. doi: 10.1097/01.brs.0000182087.35335.05.
citation: Glassman SD, Dimar JR, Carreon LY, Campbell MJ, Puno RM, Johnson JR. Initial fusion rates with recombinant human bone morphogenetic protein-2/compression resistant matrix and a hydroxyapatite and tricalcium phosphate/collagen carrier in posterolateral spinal fusion. Spine (Phila Pa 1976). 2005 Aug 1;30(15):1694-8. doi: 10.1097/01.brs.0000172157.39513.80.
citation: Vaccaro AR, Anderson DG, Patel T, Fischgrund J, Truumees E, Herkowitz HN, Phillips F, Hilibrand A, Albert TJ, Wetzel T, McCulloch JA. Comparison of OP-1 Putty (rhBMP-7) to iliac crest autograft for posterolateral lumbar arthrodesis: a minimum 2-year follow-up pilot study. Spine (Phila Pa 1976). 2005 Dec 15;30(24):2709-16. doi: 10.1097/01.brs.0000190812.08447.ba.
citation: Dimar JR, Glassman SD, Burkus KJ, Carreon LY. Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/compression resistant matrix versus iliac crest bone graft. Spine (Phila Pa 1976). 2006 Oct 15;31(22):2534-9; discussion 2540. doi: 10.1097/01.brs.0000240715.78657.81.
citation: Niu CC, Tsai TT, Fu TS, Lai PL, Chen LH, Chen WJ. A comparison of posterolateral lumbar fusion comparing autograft, autogenous laminectomy bone with bone marrow aspirate, and calcium sulphate with bone marrow aspirate: a prospective randomized study. Spine (Phila Pa 1976). 2009 Dec 1;34(25):2715-9. doi: 10.1097/BRS.0b013e3181b47232.
citation: Taghavi CE, Lee KB, Keorochana G, Tzeng ST, Yoo JH, Wang JC. Bone morphogenetic protein-2 and bone marrow aspirate with allograft as alternatives to autograft in instrumented revision posterolateral lumbar spinal fusion: a minimum two-year follow-up study. Spine (Phila Pa 1976). 2010 May 15;35(11):1144-50. doi: 10.1097/BRS.0b013e3181bb5203.