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Spinal StenosisNCT02064855

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

An observational study of Spinal Stenosis and Spondylolisthesis, run by K2M, Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
108 participants
Where
No sites listed yet
Study dates
Aug 2014to 12 Dec 2019
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects will be identified from the surgeon's practice.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

About this study

Official title: 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.

Keywords
Spinal stenosis, Spondylolisthesis, Degenerative disc disease, Spinal fusion, Allograft, Interbody fusion
Medical subject headings
Spinal Stenosis, Spondylolisthesis, Intervertebral Disc Degeneration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events

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

    Measured: 24 months

  2. 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.

    Measured: 12 months

Secondary outcomes (12)

  1. 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

    Measured: 12m

  2. 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

    Measured: 12 Months and 24 Months

  3. 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%.

    Measured: Baseline (Pre-Op), 24 months

  4. 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

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

  5. 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.

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

  6. Patient Satisfaction

    Patient Satisfaction at 12 Mo and 24 Mo

    Measured: 12 months, 24 months

  7. Length of Surgery Time

    The length of the surgical procedure from the initial incision to final closure.

    Measured: At time of surgery

  8. Length of Anesthesia Time

    The length of time the patient is under anesthesia.

    Measured: At time of surgery

  9. Estimated Blood Loss

    The amount of blood loss over the entire length of the surgery

    Measured: At time of surgery

  10. Length of Hospital Stay

    The length of the hospital stay from the date of admission to the date of discharge .

    Measured: Admission to discharge

  11. 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.

    Measured: Pre-Op to 24 months

  12. Use of Narcotics Post-surgery

    The types and dosages of any narcotics taken by the patient post-surgery will be documented.

    Measured: Pre-Op to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2014 (estimated)
  2. Study startAug 2014
  3. Primary completion29 Aug 2019
  4. Study completion12 Dec 2019

Why it stopped: The study was terminated early due to slow enrollment and difficulties with long-term follow-up

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02064855
Sponsor's protocol ID
CA-003
Status last verified
Feb 2021
First submitted
11 Feb 2014
Last updated
1 Mar 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15014276

  • 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.

    PubMed 16227892

  • 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.

    PubMed 16094268

  • 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.

    PubMed 16371892

  • 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.

    PubMed 17047540

  • 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.

    PubMed 19940728

  • 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.

    PubMed 20139805

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Stenosis and Spondylolisthesis, run by K2M, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02064855, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.

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