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
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Anterior Lumbar Interbody Fusion
Rothman Orthopaedic Institure
Philadelphia, Pennsylvania, United States
RECRUITINGTexas Back Institute
Plano, Texas, United States
RECRUITINGRadiographic Fusion
AP/Lateral, Flexion, Extension and CT radiographs
Time frame: 6 months
Radiographic Fusion
AP/Lateral, Flexion, Extension and CT radiographs
Time frame: 12 months
Radiographic Fusion
AP/Lateral, Flexion, Extension and CT radiographs
Time frame: 24 months
Oswestry Disability Index
Improvement in the ODI as measured by a minimum of a 15 point improvement
Time frame: up to and including 24 months
Back and Leg VAS
Improvement in the VAS as measured by a minimum of a 20 point improvement.
Time frame: 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
Time frame: up to and including 24 months
PROMIS score
Change in the PROMIS score
Time frame: up to and including 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.