Study Comparing LDGraft Device to Allograft Bone in Single Level Anterior Lumbar Interbody Fusion for Lumbar Degenerative Disc Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of LDGraft, an investigational device, compared to a 100% human tissue product allograft bone during a single level anterior lumbar interbody fusion ALIF procedure. The study focuses on patients with lumbar degenerative disc disease DDD requiring fusion at one level, aiming to assess outcomes related to spine fusion and recovery. This is a first in human, prospective, randomized, single-blind, multi-center study sponsored by Locate Bio Pty Ltd. Participants will receive either one of two doses of LDGraft 0.5mgcc or 1.0mgcc rhBMP-2 or the control allograft bone. The assigned treatment is applied within an intervertebral cage, followed by placement of anterior fixation with a plate and screws during the ALIF surgery. The surgical and postoperative care will follow standard clinical practice. Patients are randomly assigned in a 332 ratio to the two LDGraft dose groups or the control group. During the study, participants will be monitored at multiple time points up to 24 months after surgery. Assessments include radiographic fusion, secondary surgical interventions, Oswestry Disability Index ODI scores, neurological condition, and device-related adverse events. Additional measurements such as visual analog scores for back and leg pain will also be collected. The study involves regular imaging and clinical evaluations to track safety and effectiveness over two years.

LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)