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

NCT01557829 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-04-04

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Posterior lumbar interbody fusion with a PEEK cage

PEEK cage suitable for oblique placement in the lumbar spine

DEVICE

Posterior lumbar interbody fusion with a Valeo OL cage

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

Sponsors & Collaborators

  • Amedica Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2016-01-31
Completion
2017-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01557829 on ClinicalTrials.gov