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

February 9, 2021 updated by: K2M, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be identified from the surgeon's practice.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: 24 months
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
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Assessments
Time Frame: 12m

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
Radiographic Assessments
Time Frame: 12 Months and 24 Months

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
Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI)
Time Frame: Baseline (Pre-Op), 24 months
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
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months
Time Frame: Baseline (up to 8 weeks post-operatively) to 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
Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months
Time Frame: Baseline (up to 8 weeks post-operatively) to 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
Patient Satisfaction
Time Frame: 12 months, 24 months
Patient Satisfaction at 12 Mo and 24 Mo
12 months, 24 months
Length of Surgery Time
Time Frame: At time of surgery
The length of the surgical procedure from the initial incision to final closure.
At time of surgery
Length of Anesthesia Time
Time Frame: At time of surgery
The length of time the patient is under anesthesia.
At time of surgery
Estimated Blood Loss
Time Frame: At time of surgery
The amount of blood loss over the entire length of the surgery
At time of surgery
Length of Hospital Stay
Time Frame: Admission to discharge
The length of the hospital stay from the date of admission to the date of discharge .
Admission to discharge
Time to Return to Work/School
Time Frame: Pre-Op to 24 months
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
Use of Narcotics Post-surgery
Time Frame: Pre-Op to 24 months
The types and dosages of any narcotics taken by the patient post-surgery will be documented.
Pre-Op to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

K2M, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

August 29, 2019

Study Completion (Actual)

December 12, 2019

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Actual)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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