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

• 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

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