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

Completed

Conditions studied: Spondylolisthesis, Scoliosis, Intervertebral Disc Disease

In brief

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.

Key facts

Study ID
NCT02225444
Run by
Bioventus LLC
People needed
42
Starts
2015-11-19
Expected to finish
2019-10-11
Last updated by the study team
2020-11-05

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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