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

Amedica

Status: Completed

Conditions: Isthmic Spondylolisthesis of Grade I or II; Degenerative Spondylolisthesis; Disc Degeneration of Pfirrmann Grade III or Greater

Treatments: Device: Posterior lumbar interbody fusion with a Valeo OL cage; Device: Posterior lumbar interbody fusion with a PEEK cage

Study type: Interventional

Funder types: Industry

Identifiers

NCT01557829

NL34808.100.10 (Registry Identifier)

Amedica 2011-9

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

PEEK interbody cage

Active Comparator group

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.

Treatment:

Device: Posterior lumbar interbody fusion with a PEEK cage

Valeo OL ceramic cage

Experimental group

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.

Treatment:

Device: Posterior lumbar interbody fusion with a Valeo OL cage