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LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
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).
Study details:
This is a prospective, randomized, controlled, single-blind, dose-finding, multi-center study which intends to demonstrate the safety of both LDGraft groups versus allograft during a single level ALIF procedure. This is a first in human (FIH) study. The study will enroll patients with lumbar degenerative disc disease (DDD) requiring single level ALIF.
The procedure will involve use of an intervertebral cage and fixation (plate and screws). Upon successful completion of the Screening period and confirmation of eligibility the participant will allocated 3:3:2 to the LDGraft groups (investigational) or the allograft control group. Participants will be blinded to the treatment assigned however the surgical procedure and the post operative recovery will be managed in accordance with standard clinical practice for anterior lumbar interbody fusion.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 22 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-09-01
Primary completion: 2027-07-01
Study completion finish: 2027-07-01
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT06462729
Intervention or treatment
DEVICE: LDGraft
DEVICE: LDGraft
OTHER: Allograft Bone
Conditions
- • Degenerative Disc Disease
- • Lumbar Disc Disease
- • Spine Disease
- • Lumbar Spine Degeneration
Find a site
Closest Location:
Macquarie University
Research sites nearby
Select from list below to view details:
Macquarie University
Sydney, New South Wales, Australia
Newcastle Private Hospital
Newcastle, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: LDGraft 0.5mg/cc
| DEVICE: LDGraft
|
EXPERIMENTAL: LDGraft 1.0mg/cc
| DEVICE: LDGraft
|
ACTIVE_COMPARATOR: Control Allograft Bone
| OTHER: Allograft Bone
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Radiographic Fusion | Radiographic fusion defined as evidence of bridging bone by CT scan | 12 months and 24 months |
Secondary Surgical Intervention | No index level secondary surgical intervention | 12 months and 24 months |
Oswestry Disability Index (ODI) Score | At least 15-point improvement in Oswestry Disability Index (ODI) compared to baseline | 12 months and 24 months |
Neurological Condition | No new or worsening persistent lumbar spine neurological condition compared to baseline | 12 months and 24 months |
Serious Device-Related Adverse Events | No serious device-related adverse events | 12 months and 24 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Radiographic Outcomes | Radiographic outcomes including bridging bone, radiolucency, device condition, migration, subsidence, angular motion, and translational motion | 6 weeks, 3 months, 6 months, 12 months and 24 months |
Visual Analog Score (VAS) Back | Improvement in the Visual Analog Score (VAS) back pain of 20mm compared to baseline | 6 weeks, 3 months, 6 months, 12 months and 24 months |
Visual Analog Score (VAS) Change Back | Mean change in back VAS over time intervals | 6 weeks, 3 months, 6 months, 12 months and 24 months |
Visual Analog Score (VAS) Leg | Improvement in the Visual Analog Score (VAS) worst leg of 20mm compared to baseline | 6 weeks, 3 months, 6 months, 12 months and 24 months |
Visual Analog Score (VAS) Change Leg | Mean change in leg VAS over time intervals | 6 weeks, 3 months, 6 months, 12 months and 24 months |
Oswestry Disability Index (ODI) Score | Improvement in ODI of 15 points compared to baseline | 6 weeks, 3 months, 6 months, 12 months and 24 months |
Oswestry Disability Index (ODI) Change | Mean change in ODI over time intervals | 6 weeks, 3 months, 6 months, 12 months and 24 months |
Frequently Asked Questions
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