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

NCT04566874 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-09-28

No results posted yet for this 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

Conditions

  • Degenerative Disc Disease
  • Spinal Stenosis
  • Spondylolisthesis
  • Scoliosis

Interventions

DEVICE

ALIF

Anterior Lumbar Interbody Fusion

Sponsors & Collaborators

  • Camber Spine Technologies

    lead INDUSTRY

Principal Investigators

  • David Kaye, MD · Rothman Orthopaedic Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2021-07-31
Completion
2021-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04566874 on ClinicalTrials.gov