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NCT Number: NCT01557829

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

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.

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Key information

Conditions

Disc Degeneration of Pfirrmann Grade III or Greater Bone Diseases Degenerative Spondylolisthesis Intervertebral Disc Degeneration Isthmic Spondylolisthesis of Grade I or II Musculoskeletal Diseases Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Center Haaglanden, The Hague, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Posterior lumbar interbody fusion with a PEEK cage

Device

PEEK cage suitable for oblique placement in the lumbar spine

Other names: Amedica Phantom Plus or Pioneer Bullet-Tip cage

Posterior lumbar interbody fusion with a Valeo OL cage

Device

Posterior lumbar interbody fusion with a single Valeo OL ceramic cage.

Other names: Valeo OL, silicon nitride ceramic

Primary outcomes

  1. Roland Morris Disability Questionnaire (RMDQ)

    Time frame: 12 months post-op

    The improvement in the RMDQ over the pre-op RMDQ value for each group will be compared

Secondary outcomes

  1. Fusion status

    Time frame: 3 mo., 6 mo., 12 mo., 24 months

    Plane film radiographs will be used to assess fusion at all four follow-up periods. At 12 months a CT scan will be performed.

  2. Oswestry Disability Index (ODI)

    Time frame: 12 months post-op

    The improvement in the ODI over the pre-op ODI for each Group

Sponsors and collaborators

Lead sponsor

Amedica Corporation

Industry

Registry information

Official study title

Clinical Study of the Amedica Corporation Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion

Acronym: SNAP

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Mar 20, 2012
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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