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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Amedica Corporation Identifier:
First received: March 16, 2012
Last updated: January 20, 2015
Last verified: January 2015

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 2017
Estimated Primary Completion Date: January 2016 (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


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

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
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.

Please refer to this study by its identifier: NCT01557829

Medical Center Haaglanden
The Hague, Netherlands, 2501 CK
Utrecht, Netherlands
Sponsors and Collaborators
Amedica Corporation
  More Information

No publications provided by Amedica Corporation

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Amedica Corporation Identifier: NCT01557829     History of Changes
Other Study ID Numbers: Amedica 2011-9, NL34808.100.10
Study First Received: March 16, 2012
Last Updated: January 20, 2015
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylosis processed this record on October 06, 2015