LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
Trial Parameters
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Brief Summary
The objective of this study is to evaluate the safety and effectiveness of LDGraft (investigational device) compared to 100% human tissue product allograft bone (control) when applied in an ALIF procedure in the treatment of patients with lumbar degenerative disc disease (DDD).
Eligibility Criteria
Inclusion Criteria: 1. Skeletally mature adults ≥22 and ≤80 years at the time of surgery 2. Willing and able to give written informed consent and comply with study protocol and postoperative management program 3. Degenerative disc disease of the lumbosacral spine in one level (L3 to S1) requiring fusion confirmed by patient history and radiographic imaging (CT/MRI/X-rays) with one or more of the following: * instability (as defined by ≥3mm translation or ≥5° angulation); * osteophyte formation of facet joints or vertebral endplates; * decreased disc height, on average by \>2mm, but dependent upon the spinal level; * scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule; * herniated nucleus pulposus; * facet joint degeneration/changes; and/or * vacuum phenomenon. 4. Preoperative Oswestry Disability Index score ≥ 35 5. Participant has not responded to conservative treatment (e.g. medications, injections, physical therapy, etc.) for a period of 6 months 6. Par