Clinical trial NCT04566874: SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Degenerative Disc Disease
Spinal Stenosis
Spondylolisthesis
Scoliosis
Keywords: lumbar spinal fusion
Lead sponsor: Camber Spine Technologies
Sponsor class: INDUSTRY
First posted: 2020-09-28
Enrollment: 100
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single blind randomized 1:1
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Radiographic Fusion
timeFrame: 6 months
measure: Radiographic Fusion
timeFrame: 12 months
measure: Radiographic Fusion
timeFrame: 24 months
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: up to and including 24 months
measure: Back and Leg VAS
timeFrame: up to and including 24 months
measure: VR-12 Health Survey
timeFrame: up to and including 24 months
measure: PROMIS score
timeFrame: up to and including 24 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institure
state: Pennsylvania
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
Study officials:
affiliation: Rothman Orthopaedic Institute
name: David Kaye, MD
role: PRINCIPAL_INVESTIGATOR
References: