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Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion SNAP Trial

This study is currently recruiting participants.
Verified March 2012 by Amedica Corporation
Sponsor:
Information provided by (Responsible Party):
Amedica Corporation
ClinicalTrials.gov Identifier:
NCT01557829
First received: March 16, 2012
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will measure and compare pain and disability improvement with the two implanted devices over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.


Condition Intervention Phase
Disc Degeneration of Pfirrmann Grade III or Greater
Degenerative Spondylolisthesis
Isthmic Spondylolisthesis of Grade I or II
 Device: Posterior lumbar interbody fusion with a PEEK cage
Device: Posterior lumbar interbody fusion with a Valeo OL cage
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Study of the Amedica Corporation Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion

Further study details as provided by Amedica Corporation:

Primary Outcome Measures:
  • Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: 12 months post-op ] [ Designated as safety issue: No ]
    The improvement in the RMDQ over the pre-op RMDQ value for each group will be compared


Secondary Outcome Measures:
  • Fusion status [ Time Frame: 3 mo., 6 mo., 12 mo., 24 months ] [ Designated as safety issue: No ]
    Plane film radiographs will be used to assess fusion at all four follow-up periods. At 12 months a CT scan will be performed.


Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PEEK interbody cage
Interbody spacer (cage) made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is filled with local bone or bone harvested from the iliac crest.
 Device: Posterior lumbar interbody fusion with a PEEK cage
PEEK cage suitable for oblique placement in the lumbar spine
Other Name: Amedica Phantom Plus or Pioneer Bullet-Tip cage
Experimental: Valeo OL ceramic cage
The Valeo OL cage is a silicon nitride ceramic interbody spacer. The center area of the cage is filled with autograft local bone or bone harvested from the iliac crest.
 Device: Posterior lumbar interbody fusion with a Valeo OL cage
Posterior lumbar interbody fusion with a single Valeo OL ceramic cage.
Other Names:
  • Valeo OL
  • silicon nitride ceramic

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients age 18-75 years
  • Chronic low back pain unresponsive to at least six months of conservative care
  • MRI and standing x-ray evidence of Pfirrmann Grade III or greater disc degeneration and/or degenerative or isthmic spondylolisthesis of Grade I or II

Exclusion Criteria:

  • Osteoporosis
  • Patients with prior failed fusion at the same level
  • Degenerative scoliosis
  • Degenerative spondylolisthesis greater than Grade II
  • Pregnancy
  • Psychiatric or mental disease
  • Alcoholism (drinking more than 5 units per day)
  • Active infection or prior infection at the surgical site
  • Active cancer
  • Insufficient language skills to complete questionnaires
  • Participation in another study
  • More than two symptomatic levels that need fusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557829

Contacts
Contact: Steven van Gaalen, M.D. Ph.D. (+31) 088-2505000 svgaale1@diakhuis.nl
Contact: Roel Kersten, M.D. (+31) 088-2505000 rkersten@diakhuis.nl

Locations
Netherlands
Medical Center Haaglanden Not yet recruiting
The Hague, Netherlands, 2501 CK
Principal Investigator: Mark P. Arts, MD PhD            
Sub-Investigator: Jasper Wolfs, MD, PhD            
Diakonessenhuis Recruiting
Utrecht, Netherlands
Contact: Steven van Gaalen, M.D., Ph.D.     (+31) 088-2505000     smgaalen@diakhuis.nl    
Contact: Roel Kersten, M.D.     (+31) 088-2505000     rkersten@diakhuis.nl    
Principal Investigator: Steven van Gaalen, M.D., PhD.            
Sponsors and Collaborators
Amedica Corporation
  More Information

No publications provided

Responsible Party: Amedica Corporation
ClinicalTrials.gov Identifier: NCT01557829     History of Changes
Other Study ID Numbers: Amedica 2011-9, NL34808.100.10
Study First Received: March 16, 2012
Last Updated: March 19, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Amedica Corporation:
spondylolisthesis
disc degeneration
lumbar interbody fusion
randomized controlled trial
ceramic interbody spacer

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

ClinicalTrials.gov processed this record on May 23, 2013