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

Last updated: September 23, 2020
Sponsor: Camber Spine Technologies
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Stenosis

Ankylosing Spondylitis

Spondylolisthesis

Treatment

N/A

Clinical Study ID

NCT04566874
SPA-2018
  • Ages 22-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 100
Study Start date:
July 13, 2020
Estimated Completion Date:
July 31, 2021

Study 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).

Connect with a study center

  • Rothman Orthopaedic Institure

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Texas Back Institute

    Plano, Texas 75093
    United States

    Active - Recruiting

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