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A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP®

NCT02225444 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2020-11-05

No results posted yet for this study

Summary

OsteoAMP is a novel allograft bone graft substitute (BGS) that has been processed to retain multiple endogenous growth factors for use in spinal fusion. The study is designed to obtain a higher level of clinical evidence for OsteoAMP in spinal fusion procedures and not to garner FDA regulatory approval. This is a prospective, non-randomized, non-controlled, multi-center study of OsteoAMP in instrumented, posterolateral lumbar fusion (PLF) in patients with degenerative disc disease, degenerative spondylolisthesis (up to grade 1), and/or mild degenerative scoliosis, up to 25 degree curvature. Patients that are scheduled to undergo instrumented, posterolateral spinal fusion surgery as part of their medical treatment and comply with the study eligibility criteria will be given the opportunity to consent and be entered into the study.

Conditions

  • Spondylolisthesis
  • Scoliosis
  • Intervertebral Disc Disease

Interventions

OTHER

OsteoAMP

OsteoAMP in posterolateral fusion procedure of the lumbosacral spine

Sponsors & Collaborators

  • West Virginia University

    collaborator OTHER

  • Rush University Medical Center

    collaborator OTHER

  • University of Kansas

    collaborator OTHER

  • Bioventus LLC

    lead INDUSTRY

Principal Investigators

  • Scott Daffner, MD · West Virginia University

  • Howard An, MD · Rush University Medical Center

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-19
Primary Completion
2019-06-24
Completion
2019-10-11

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 NCT02225444 on ClinicalTrials.gov