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

Study Overview
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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.

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

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

Intervention / Treatment
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* Device: Posterior lumbar interbody fusion with a PEEK cage
* Device: Posterior lumbar interbody fusion with a Valeo OL cage


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PEEK interbody cage<br>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. | Device: Posterior lumbar interbody fusion with a PEEK cage<br>* PEEK cage suitable for oblique placement in the lumbar spine<br>* Other names: Amedica Phantom Plus or Pioneer Bullet-Tip cage;|
| Experimental: Valeo OL ceramic cage<br>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. | Device: Posterior lumbar interbody fusion with a Valeo OL cage<br>* Posterior lumbar interbody fusion with a single Valeo OL ceramic cage.<br>* Other names: silicon nitride ceramic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Oswestry Disability Index (ODI) | The improvement in the ODI over the pre-op ODI for each Group | 12 months post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spondylolisthesis, disc degeneration, lumbar interbody fusion, randomized controlled trial, ceramic interbody spacer