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

Camber Spine Technologies

Status: Unknown

Conditions: Degenerative Disc Disease; Spondylolisthesis; Scoliosis; Spinal Stenosis

Treatments: Device: ALIF

Study type: Interventional

Funder types: Industry

Identifiers

NCT04566874

SPA-2018

Details and patient eligibility

About

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

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Spira-A with HCT/p DBM

Other group

Description:

Single level Spira-A 3D printed Titanium ALIF Device with HCT/p DBM

Treatment:

Device: ALIF

Medtronic PEEK ALIF with Infuse

Active Comparator group

Description:

Single level Medtronic Divergent-L/Perimeter PEEK ALIF Device with Recombinant Bone Morphogenic Protein-2 (Infuse)

Treatment:

Device: ALIF