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

Degenerative Disc Disease Clinical Trial

Official title:

The Fusion Rate With K2M VESUVIUS® Demineralized Fibers Used With K2M EVEREST® Spinal System Compared to Autologous Bone Graft With Posterior Stabilization

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02064855
• Other study ID #: CA-003
• Status: Terminated
• Start date: August 2014
• Est. completion date: December 12, 2019

Study information

• Verified date: February 2021
• Source: K2M, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: December 12, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Stenosis
• Spondylolisthesis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
K2M, Inc.

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	All adverse events will be documented including device related, procedure related and additional serious adverse events.	24 months
Primary	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	Radiographic Assessments	X-rays at pre-operative and post operative include: AP& Lateral; Flex/Ext & Oblique X-rays. Radiographic assessments being performed include: Posterior/Transverse process fusion, Right side (by level); Posterior/Transverse process fusion, Left side (by level); Anterior fusion, if TLIF procedure done, by level; Overall fusion by level; Device Condition; Device Subsidence; Device Migration	12m
Secondary	Radiographic Assessments	X-rays at post operative include: AP& Lateral; Flex/Ext & Oblique X-rays. Radiographic assessments being performed include: Device Condition Device Subsidence Device Migration	12 Months and 24 Months
Secondary	Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI)	This patient-reported outcome measure is a 10 item questionnaire that evaluates disability and functional impairment associated with back problems. Each item is scored from 0 up to 5, with higher scores corresponding to greater disability. A total ODI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the ODI score ranges from 0% to 100%.	Baseline (Pre-Op), 24 months
Secondary	Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months	VAS scale ranged from 0 to 100mm with the 100mm accounting for the highest level of pain	Baseline (up to 8 weeks post-operatively) to 24 months
Secondary	Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months	SF-12v2 ranged between 0 and 100 points. The higher the points the better the self-assessed quality of life.	Baseline (up to 8 weeks post-operatively) to 24 months
Secondary	Patient Satisfaction	Patient Satisfaction at 12 Mo and 24 Mo	12 months, 24 months
Secondary	Length of Surgery Time	The length of the surgical procedure from the initial incision to final closure.	At time of surgery
Secondary	Length of Anesthesia Time	The length of time the patient is under anesthesia.	At time of surgery
Secondary	Estimated Blood Loss	The amount of blood loss over the entire length of the surgery	At time of surgery
Secondary	Length of Hospital Stay	The length of the hospital stay from the date of admission to the date of discharge .	Admission to discharge
Secondary	Time to Return to Work/School	The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery by looking at the percentage increase of participants who were able to return to work without any restrictions.	Pre-Op to 24 months
Secondary	Use of Narcotics Post-surgery	The types and dosages of any narcotics taken by the patient post-surgery will be documented.	Pre-Op to 24 months