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

April 3, 2017 updated by: Amedica Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • The Hague, Netherlands, 2501 CK
        • Medical Center Haaglanden
      • Utrecht, Netherlands
        • Diakonessenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PEEK interbody cage
Posterior fusion with an 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 Names:
  • Amedica Phantom Plus or Pioneer Bullet-Tip cage
Experimental: Valeo OL ceramic cage
Posterior fusion with the Valeo OL cage, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 mo., 6 mo., 12 mo., 24 months
Oswestry Disability Index (ODI)
Time Frame: 12 months post-op
The improvement in the ODI over the pre-op ODI for each Group
12 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amedica Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (Estimate)

March 20, 2012

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Amedica 2011-9
  • NL34808.100.10 (Registry Identifier: Netherlands Clinical Trials Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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