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

Not Applicable

Completed

• Conditions: Degenerative Spondylolisthesis; Disc Degeneration of Pfirrmann Grade III or Greater; Isthmic Spondylolisthesis of Grade I or II
• Interventions: Device: Posterior lumbar interbody fusion with a PEEK cage; Device: Posterior lumbar interbody fusion with a Valeo OL cage

• Registration Number: NCT01557829
• Lead Sponsor: Amedica Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-20
• Primary Completion: 2016-01
• Study Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEEK interbody cage	Posterior lumbar interbody fusion with a PEEK 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.
Valeo OL ceramic cage	Posterior lumbar interbody fusion with a Valeo OL 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.

Primary Outcome Measures

Name	Time	Method
Roland Morris Disability Questionnaire (RMDQ)	12 months post-op	The improvement in the RMDQ over the pre-op RMDQ value for each group will be compared

Secondary Outcome Measures

Name	Time	Method
Fusion status	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.
Oswestry Disability Index (ODI)	12 months post-op	The improvement in the ODI over the pre-op ODI for each Group

Trial Locations

Locations (2)

Medical Center Haaglanden; 🇳🇱 The Hague, Netherlands

Diakonessenhuis; 🇳🇱 Utrecht, Netherlands