Degenerative Disc Disease, Scoliosis, Spinal Stenosis, Spondylolisthesis
Conditions
Keywords
lumbar spinal fusion
Brief summary
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
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).
Interventions
DEVICEALIF
Anterior Lumbar Interbody Fusion
Sponsors
Camber Spine Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
subjects will be blinded prior to surgery. Following surgery, maintaining masking may not be feasible as subjects will have access to medical records and/or radiographs.
Intervention model description
single blind randomized 1:1
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Fusion | 6 months | AP/Lateral, Flexion, Extension and CT radiographs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index | up to and including 24 months | Improvement in the ODI as measured by a minimum of a 15 point improvement |
| Back and Leg VAS | up to and including 24 months | Improvement in the VAS as measured by a minimum of a 20 point improvement. |
| VR-12 Health Survey | up to and including 24 months | Improvement in the VR-12 Health Survey as demonstrated by pre-op and post-op evaluation |
| PROMIS score | up to and including 24 months | Change in the PROMIS score |
Countries
United States
Contacts
Primary ContactDonald W Guthner, BS
Backup ContactNoel Hetrick
Outcome results
None listed