LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age22-80
SponsorLocate Bio Pty Ltd
About this trial
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
Qualifiers
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
instability (as defined by ≥3mm translation or ≥5° angulation);
osteophyte formation of facet joints or vertebral endplates;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- LDGraft
- LDGraft
- Allograft Bone
Treatment groups
40 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov