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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
LDGraft
DeviceLDGraft 0.5mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)
LDGraft
DeviceLDGraft 1.0mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)
Allograft Bone
Other interventionAllograft bone (100% human tissue product) applied within intervertebral cage with placement of anterior fixation (plate and screws)
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: LDGraft 0.5mg/ccExperimental treatment 1 intervention
Group B: LDGraft 1.0mg/ccExperimental treatment 1 intervention
Group C: Control Allograft BoneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Radiographic Fusion
Radiographic fusion defined as evidence of bridging bone by CT scan
Time frame
12 months and 24 months2
Secondary Surgical Intervention
No index level secondary surgical intervention
Time frame
12 months and 24 months3
Oswestry Disability Index (ODI) Score
At least 15-point improvement in Oswestry Disability Index (ODI) compared to baseline
Time frame
12 months and 24 months4
Neurological Condition
No new or worsening persistent lumbar spine neurological condition compared to baseline
Time frame
12 months and 24 monthsSecondary outcomes
1
Radiographic Outcomes
Radiographic outcomes including bridging bone, radiolucency, device condition, migration, subsidence, angular motion, and translational motion
Time frame
6 weeks, 3 months, 6 months, 12 months and 24 months2
Visual Analog Score (VAS) Back
Improvement in the Visual Analog Score (VAS) back pain of 20mm compared to baseline
Time frame
6 weeks, 3 months, 6 months, 12 months and 24 months3
Visual Analog Score (VAS) Change Back
Mean change in back VAS over time intervals
Time frame
6 weeks, 3 months, 6 months, 12 months and 24 months4
Visual Analog Score (VAS) Leg
Improvement in the Visual Analog Score (VAS) worst leg of 20mm compared to baseline
Time frame
6 weeks, 3 months, 6 months, 12 months and 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov