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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-13

Study Completion Date

2021-07-31

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

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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).

Conditions

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Degenerative Disc Disease Spinal Stenosis Spondylolisthesis Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single blind randomized 1:1

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Spira-A with HCT/p DBM

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

Group Type OTHER

ALIF

Intervention Type DEVICE

Anterior Lumbar Interbody Fusion

Medtronic PEEK ALIF with Infuse

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

Group Type ACTIVE_COMPARATOR

ALIF

Intervention Type DEVICE

Anterior Lumbar Interbody Fusion

Interventions

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ALIF

Anterior Lumbar Interbody Fusion

Intervention Type DEVICE

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

Minimum Eligible Age

22 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No