Actively Recruiting
A Randomized Study of LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
Led by Locate Bio Pty Ltd · Updated on 2026-05-27
40
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of LDGraft, an investigational device, compared to a 100% human tissue product allograft bone during a single level anterior lumbar interbody fusion (ALIF) procedure. The study focuses on patients with lumbar degenerative disc disease (DDD) requiring fusion at one level, aiming to assess outcomes related to spine fusion and recovery. This is a first in human, prospective, randomized, single-blind, multi-center study sponsored by Locate Bio Pty Ltd. Participants will receive either one of two doses of LDGraft (0.5mg/cc or 1.0mg/cc rhBMP-2) or the control allograft bone. The assigned treatment is applied within an intervertebral cage, followed by placement of anterior fixation with a plate and screws during the ALIF surgery. The surgical and postoperative care will follow standard clinical practice. Patients are randomly assigned in a 3:3:2 ratio to the two LDGraft dose groups or the control group. During the study, participants will be monitored at multiple time points up to 24 months after surgery. Assessments include radiographic fusion, secondary surgical interventions, Oswestry Disability Index (ODI) scores, neurological condition, and device-related adverse events. Additional measurements such as visual analog scores for back and leg pain will also be collected. The study involves regular imaging and clinical evaluations to track safety and effectiveness over two years.
CONDITIONS
Brief Title
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 22 to 80 years at the time of surgery
- Able and willing to provide written informed consent and follow the study protocol
- Diagnosed with degenerative disc disease at one level of the lumbosacral spine (L3 to S1) confirmed by imaging and patient history
- Must have one or more signs such as spinal instability, osteophyte formation, decreased disc height, scarring or thickening of spinal ligaments, herniated nucleus pulposus, facet joint changes, or vacuum phenomenon
- Preoperative Oswestry Disability Index (ODI) score of 35 or higher
- Have not responded to conservative treatments like medications, injections, or physical therapy for at least 6 months
- Suitable candidate for anterior lumbar interbody fusion (ALIF) surgery
You will not qualify if you...
- Previous lumbar spine instrumentation or fusion surgery
- Need for fusion at more than one lumbar spine level
- Require decompression at three or more contiguous lumbar spine levels
- Known allergy or hypersensitivity to study treatment components including BMP-2 proteins
- Pregnant, planning pregnancy during follow-up, or breastfeeding
- Active cancer
- Need for bone growth stimulation in the lumbar spine
- Active local or systemic infection
- Spondylolisthesis greater than Grade 1 (more than 25% translation)
- Current smoking or nicotine use within 30 days prior to screening
- Degenerative muscular or neurological conditions interfering with outcome evaluation
- Medical treatments or radiation that may affect bone or soft tissue healing
- Body mass index over 35
- Insulin-dependent diabetes mellitus
- Osteopenia or osteoporosis of the spine
- Secondary causes of osteoporosis or conditions affecting bone growth
- Participation in other investigational studies recently
- History of chemical or alcohol abuse
- Behavioral, cognitive, social, or medical problems affecting study assessments
- Vertebral body damage from trauma at the surgical site
- Currently a prisoner
- Active litigation related to spinal condition or workers compensation claimants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus initial hospital recovery period
Participants undergo a single level anterior lumbar interbody fusion (ALIF) procedure using either LDGraft or allograft bone with placement of anterior fixation (plate and screws). Post-operative recovery is managed according to standard clinical practice.
1 surgery visit and hospital stay
Duration - Up to 24 months
Participants are monitored for safety and effectiveness outcomes through clinical assessments and imaging visits following their surgery.
Visits at 6 weeks, 3 months, 6 months, 12 months, and 24 months
Trial Site Locations
Total: 3 locations
1
Orthopaedics NorthEast
Fort Wayne, Indiana, United States, 46825
Actively Recruiting
2
Pinehurst Surgical Clinic
Pinehurst, North Carolina, United States, 28374
Actively Recruiting
3
Newcastle Private Hospital
Newcastle, New South Wales, Australia, 2305
Actively Recruiting
Research Team
R
Robyn Cochrane
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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