A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP®
Condition: Spondylolisthesis; Scoliosis; Intervertebral Disc Disease
MeSH terms: Scoliosis; Spondylolisthesis
Study type: Observational

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.
    

Detailed description: 
      The objective of this clinical study are: to evaluate the long term efficacy of OsteoAMP in
      patients requiring 1 to 2 adjacent level, instrumented posterolateral spinal fusion procedure
      of the lumbar or lumbosacral spine, and to evaluate OsteoAMP in spinal fusion procedures
      based on fusion results, adverse event rates, and pain and health scores.

      Patients that are scheduled to undergo instrumented, posterolateral spinal fusion (PLF)
      surgery as part of their medical treatment and comply with the study eligibility criteria
      will be recruited and entered into the study. Subjects recruited into the study will receive
      OsteoAMP as part of an instrumented PLF surgical procedure. The surgery may also include
      nerve root decompressions through laminectomies and foraminotomies. As is consistent with the
      current standard of care.

      The study involves consecutive patients suffering from lower back and leg pain due to
      degenerative disc disease (DDD), degenerative spondylolisthesis (up to grade 1), and/or mild
      degenerative scoliosis that are candidates for an instrumented PLF with pedicle screws in 1
      or 2 motion segments of the lumbar or lumbosacral spine. Patients will require a total bone
      graft volume of at least 10cc per side per level in the PLF procedure, including OsteoAMP
      granules hydrated with bone marrow aspirate (BMA) and local autogenous bone.

      Subjects will be followed for 24 months post-surgery.
    

Intervention name(s): OsteoAMP
Intervention type(s): Other
Intervention description(s): OsteoAMP in posterolateral fusion procedure of the lumbosacral spine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female patients between 21 and 75 years old with degenerative disc disease,
        degenerative spondylolisthesis (up to grade 1), and/or mild degenerative scoliosis (up to
        25° curvature) that have failed conservative treatment and are now indicated for
        instrumented posterolateral spinal fusion at 1 or 2 contiguous levels between L1-S1.
      
Keywords: degenerative lumbosacral spine disease; posterolateral fusion evaluation; OsteoAMP; autograft