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

NCT02064855 | Terminated Results DMC

• 1 other identifier: CA-003
• Study Type: observational
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Stenosis; Spondylolisthesis; Degenerative Disc Disease

Keywords

Spinal stenosis; Spondylolisthesis; Degenerative disc disease; Spinal fusion; Allograft; Interbody fusion

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events

  All adverse events will be documented including device related, procedure related and additional serious adverse events.

  24 months

• Fusion Status on CT at 12 Months

  Fusion is categorized as Partial consolidation and Bridging/Fusion. Partial consolidation is defined as consolidation of bone graft material with no complete bridging seen. Bridging/Fusion is defined as clear evidence of solid bridging bone between posterolateral gutters, facet joints and/or transverse processes.

  12 months

Secondary Outcomes (12)

• Radiographic Assessments

  12m

• Radiographic Assessments

  12 Months and 24 Months

• Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI)

  Baseline (Pre-Op), 24 months

• Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months

  Baseline (up to 8 weeks post-operatively) to 24 months

• Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months

  Baseline (up to 8 weeks post-operatively) to 24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be identified from the surgeon's practice.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• K2M, Inc.: lead

Related Publications (7)

• 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.

  PMID: 15014276 BACKGROUND

• 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.

  PMID: 16227892 BACKGROUND

• 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.

  PMID: 16094268 BACKGROUND

• 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.

  PMID: 16371892 BACKGROUND

• 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.

  PMID: 17047540 BACKGROUND

• 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.

  PMID: 19940728 BACKGROUND

• 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.

  PMID: 20139805 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis; Spondylolisthesis; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Marissa Conrad, Senior Director of Clinical and Medical Affairs
• Organization: Stryker Spine

marissa.conrad@stryker.com

201-749-8162

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 17, 2014
• Study Start: August 1, 2014
• Primary Completion: August 29, 2019
• Study Completion: December 12, 2019
• Last Updated: March 1, 2021
• Results First Posted: March 1, 2021

Record last verified: 2021-02