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.
Information provided by (Responsible Party):
First received: February 11, 2014
Last updated: August 7, 2015
Last verified: August 2015
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.
Degenerative Disc Disease
|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:
U.S. FDA Resources
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.
|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)|
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