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

Primary Purpose

Disc Degeneration of Pfirrmann Grade III or Greater, Degenerative Spondylolisthesis, Isthmic Spondylolisthesis of Grade I or II

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Posterior lumbar interbody fusion with a PEEK cage
Posterior lumbar interbody fusion with a Valeo OL cage
Sponsored by
Amedica Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disc Degeneration of Pfirrmann Grade III or Greater focused on measuring spondylolisthesis, disc degeneration, lumbar interbody fusion, randomized controlled trial, ceramic interbody spacer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Center Haaglanden
  • Diakonessenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PEEK interbody cage

Valeo OL ceramic cage

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Roland Morris Disability Questionnaire (RMDQ)
The improvement in the RMDQ over the pre-op RMDQ value for each group will be compared

Secondary Outcome Measures

Fusion status
Plane film radiographs will be used to assess fusion at all four follow-up periods. At 12 months a CT scan will be performed.
Oswestry Disability Index (ODI)
The improvement in the ODI over the pre-op ODI for each Group

Full Information

First Posted
March 16, 2012
Last Updated
April 3, 2017
Sponsor
Amedica Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01557829
Brief Title
Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion SNAP Trial
Acronym
SNAP
Official Title
Clinical Study of the Amedica Corporation Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amedica Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disc Degeneration of Pfirrmann Grade III or Greater, Degenerative Spondylolisthesis, Isthmic Spondylolisthesis of Grade I or II
Keywords
spondylolisthesis, disc degeneration, lumbar interbody fusion, randomized controlled trial, ceramic interbody spacer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEEK interbody cage
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Valeo OL ceramic cage
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Posterior lumbar interbody fusion with a PEEK cage
Other Intervention Name(s)
Amedica Phantom Plus or Pioneer Bullet-Tip cage
Intervention Description
PEEK cage suitable for oblique placement in the lumbar spine
Intervention Type
Device
Intervention Name(s)
Posterior lumbar interbody fusion with a Valeo OL cage
Other Intervention Name(s)
Valeo OL, silicon nitride ceramic
Intervention Description
Posterior lumbar interbody fusion with a single Valeo OL ceramic cage.
Primary Outcome Measure Information:
Title
Roland Morris Disability Questionnaire (RMDQ)
Description
The improvement in the RMDQ over the pre-op RMDQ value for each group will be compared
Time Frame
12 months post-op
Secondary Outcome Measure Information:
Title
Fusion status
Description
Plane film radiographs will be used to assess fusion at all four follow-up periods. At 12 months a CT scan will be performed.
Time Frame
3 mo., 6 mo., 12 mo., 24 months
Title
Oswestry Disability Index (ODI)
Description
The improvement in the ODI over the pre-op ODI for each Group
Time Frame
12 months post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Medical Center Haaglanden
City
The Hague
ZIP/Postal Code
2501 CK
Country
Netherlands
Facility Name
Diakonessenhuis
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24568365
Citation
Kersten RF, van Gaalen SM, Arts MP, Roes KC, de Gast A, Corbin TP, Oner FC. The SNAP trial: a double blind multi-center randomized controlled trial of a silicon nitride versus a PEEK cage in transforaminal lumbar interbody fusion in patients with symptomatic degenerative lumbar disc disorders: study protocol. BMC Musculoskelet Disord. 2014 Feb 25;15:57. doi: 10.1186/1471-2474-15-57.
Results Reference
derived

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

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