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Trial record 1 of 1 for:    NCT02064855
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Evaluation of Fusion Rate Using K2M VESUVIUS® Demineralized Fibers With K2M EVEREST® Spinal System

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
K2M, Inc.
ClinicalTrials.gov Identifier:
NCT02064855
First received: February 11, 2014
Last updated: August 7, 2015
Last verified: August 2015
  Purpose
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.

Condition
Spinal Stenosis
Spondylolisthesis
Degenerative Disc Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Fusion Rate With K2M VESUVIUS® Demineralized Fibers Used With K2M EVEREST® Spinal System Compared to Autologous Bone Graft With Posterior Stabilization

Resource links provided by NLM:


Further study details as provided by K2M, Inc.:

Primary Outcome Measures:
  • 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.

  • Fusion status on CT at 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Radiographic Assessments [ Time Frame: Baseline (up to 8 weeks post-operatively), 3 months, 6 months, 12 months, 24 months ]

    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

  • Change from baseline in daily functional ability scores on the Oswestry Disability Index (ODI) [ Time Frame: Baseline (up to 8 weeks post-operatively), 3 months, 6 months, 12 months, 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), 3 months, 6 months, 12 months, 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), 3 months, 6 months, 12 months, 24 months ]
  • Patient Satisfaction [ Time Frame: 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 will be captured.

  • Length of Anesthesia Time [ Time Frame: At time of surgery ]
    The length of time the patient is under anesthesia will be captured.

  • Estimated Blood Loss [ Time Frame: At time of surgery ]
    The amount of blood loss over the entire length of the surgery will be captured.

  • Length of Hospital Stay [ Time Frame: An expected average of 2-5 days ]
    The length of the hospital stay from the date of admission to the date of discharge.

  • Time to Return to Work/School [ Time Frame: Up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 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 will be documented.

  • Use of Narcotics Post-surgery [ Time Frame: Up to 24 months ]
    The types and dosages of any narcotics taken by the patient post-surgery will be documented.


Estimated Enrollment: 204
Study Start Date: August 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be identified from the surgeon's practice.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:

Responsible Party: K2M, Inc.
ClinicalTrials.gov Identifier: NCT02064855     History of Changes
Other Study ID Numbers: CA-003
Study First Received: February 11, 2014
Last Updated: August 7, 2015

Keywords provided by K2M, Inc.:
Spinal stenosis
Spondylolisthesis
Degenerative disc disease
Spinal fusion
Allograft
Interbody fusion

Additional relevant MeSH terms:
Spondylolisthesis
Spinal Stenosis
Intervertebral Disc Degeneration
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 24, 2017