LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) (NCT06462729) | Clinical Trial Compass
RecruitingPhase 1/2
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
United States, Australia40 participantsStarted 2024-11-12
Plain-language 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).
Who can participate
Age range22 Years – 80 Years
SexALL
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Inclusion criteria
✓. Skeletally mature adults ≥22 and ≤80 years at the time of surgery
✓. Willing and able to give written informed consent and comply with study protocol and postoperative management program
✓. 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:
✓. Preoperative Oswestry Disability Index score ≥ 35
✓. Participant has not responded to conservative treatment (e.g. medications, injections, physical therapy, etc.) for a period of 6 months
✓. Participant is indicated for an ALIF approach to the lumbar spine
Exclusion criteria
✕. Previous lumbar spine instrumentation (i.e., anterior disc replacement, interspinous device) or a previous interbody fusion procedure in the lumbar spine
✕. More than one level lumbar spine level requiring fusion
✕. Three or more contiguous lumbar spine levels requiring decompression (Note: Up to two contiguous levels of decompression is acceptable)
✕. Known hypersensitivity or allergy to any components of the study treatments inclusive of hypersensitivity or allergy to any BMP-2 type recombinant proteins or peptides.
✕. Pregnant, planning to become pregnant during the follow-up time period, or breast-feeding women