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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PEEK interbody 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.

Group Type ACTIVE_COMPARATOR

Posterior lumbar interbody fusion with a PEEK cage

Intervention Type DEVICE

PEEK cage suitable for oblique placement in the lumbar spine

Valeo OL ceramic 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.

Group Type EXPERIMENTAL

Posterior lumbar interbody fusion with a Valeo OL cage

Intervention Type DEVICE

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

Interventions

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Posterior lumbar interbody fusion with a PEEK cage

PEEK cage suitable for oblique placement in the lumbar spine

Intervention Type DEVICE

Posterior lumbar interbody fusion with a Valeo OL cage

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

Intervention Type DEVICE

Other Intervention Names

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Amedica Phantom Plus or Pioneer Bullet-Tip cage Valeo OL silicon nitride ceramic

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No