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

Degenerative Spondylolisthesis Clinical Trial

— SNAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557829
• Other study ID #: Amedica 2011-9
• Secondary ID: NL34808.100.10
• Status: Completed
• Phase: N/A
• First received: March 16, 2012
• Last updated: April 3, 2017
• Start date: February 2012
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: Amedica Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Posterior lumbar interbody fusion with a PEEK cage
PEEK cage suitable for oblique placement in the lumbar spine
• Posterior lumbar interbody fusion with a Valeo OL cage
Posterior lumbar interbody fusion with a single Valeo OL ceramic cage.

Locations

Country	Name	City	State
Netherlands	Medical Center Haaglanden	The Hague
Netherlands	Diakonessenhuis	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Amedica Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roland Morris Disability Questionnaire (RMDQ)	The improvement in the RMDQ over the pre-op RMDQ value for each group will be compared	12 months post-op
Secondary	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.	3 mo., 6 mo., 12 mo., 24 months
Secondary	Oswestry Disability Index (ODI)	The improvement in the ODI over the pre-op ODI for each Group	12 months post-op