SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2

Study Overview
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Brief Summary
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A prospective, randomized, controlled clinical evaluation utilizing the SPIRA™ ALIF 3-D printed titanium interbody device with DBM vs a Medtronic PEEK ALIF interbody device with BMP

Detailed Description
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This is a single blinded randomized 1:1, controlled, prospective clinical study to evaluate fusion status and patient reported outcomes in circumferential lumbar fusion between L2-S1 at a single level with posterior screw fixation (Camber Spine Orthros System) and anterior surgery consisting of one of the treatment groups: subjects treated with the SPIRA™-A Interbody Device and HCTP/p DBM or subjects treated with Medtronic Divergent-L or Perimeter™ PEEK ALIF Interbody Device and rhBMP-2 (6mg per level).

Official Title
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SPIRA™-A 3D Printed Titanium Anterior Lumbar Interbody Fusion Device and HCT/p Demineralized Bone Matrix Versus Medtronic Divergent™-L/Perimeter™ PEEK Anterior Lumbar Interbody Fusion Device and Recombinant Bone Morphogenic Protein-2

Conditions
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Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Scoliosis

Intervention / Treatment
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* Device: ALIF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: skeletally mature adults completed 6 month non-operative or conservative therapy signed informed consent back pain with radicular symptoms as evidenced by leg pain Degenerative Disc Disease involving a single level between L2 and S1 subject willing to participate in study and follow protocol subject willing to comply with Post-op management program Exclusion Criteria: systemic infection such as AIDS, HIV or Active hepatitis autoimmune disease significant metabolic disease that might compromise bone growth history of malignancy previous surgery for primary tumor, trauma or infection subject requires 2 or more levels of fusion previous spinal instrumentation or previous interbody fusion at involved level spondylolisthesis of grade greater than/equal to 2

Ages Eligible for Study
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Minimum Age: 22 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
Interventional Model Description: single blind randomized 1:1
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Spira-A with HCT/p DBM<br>Single level Spira-A 3D printed Titanium ALIF Device with HCT/p DBM | Device: ALIF<br>* Anterior Lumbar Interbody Fusion<br>|
| Active Comparator: Medtronic PEEK ALIF with Infuse<br>Single level Medtronic Divergent-L/Perimeter PEEK ALIF Device with Recombinant Bone Morphogenic Protein-2 (Infuse) | Device: ALIF<br>* Anterior Lumbar Interbody Fusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Fusion | AP/Lateral, Flexion, Extension and CT radiographs | 6 months | 
| Radiographic Fusion | AP/Lateral, Flexion, Extension and CT radiographs | 12 months | 
| Radiographic Fusion | AP/Lateral, Flexion, Extension and CT radiographs | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | Improvement in the ODI as measured by a minimum of a 15 point improvement | up to and including 24 months | 
| Back and Leg VAS | Improvement in the VAS as measured by a minimum of a 20 point improvement. | up to and including 24 months | 
| VR-12 Health Survey | Improvement in the VR-12 Health Survey as demonstrated by pre-op and post-op evaluation | up to and including 24 months | 
| PROMIS score | Change in the PROMIS score | up to and including 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar spinal fusion