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 groupsLocations
3Australia
Newcastle Private Hospital2305, NewcastleNew South Wales, Australia
United States
Orthopaedics NorthEast46825, Fort WayneIndiana, United States
Pinehurst Surgical Clinic28374, PinehurstNorth Carolina, United States
Sponsors and collaborators
Locate Bio Pty Ltd
Lead sponsor
Source ClinicalTrials.gov