Actively Recruiting
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
Led by Locate Bio Pty Ltd · Updated on 2026-01-28
40
Participants Needed
3
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 and postoperative care
- Diagnosed with degenerative disc disease in one level of the lumbosacral spine (L3 to S1) confirmed by patient history and imaging showing specific signs such as instability, osteophyte formation, decreased disc height, scarring, herniation, facet joint changes, or vacuum phenomenon
- Preoperative Oswestry Disability Index score of 35 or higher
- Have not improved after at least 6 months of conservative treatments like medications, injections, or physical therapy
- Suitable for an anterior lumbar interbody fusion (ALIF) surgical approach
You will not qualify if you...
- Previous lumbar spine surgery involving instrumentation or fusion
- More than one lumbar spine level requiring fusion
- Three or more contiguous lumbar spine levels needing decompression (up to two levels of decompression allowed)
- Known allergy or hypersensitivity to any 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 (over 25% vertebral translation)
- Current use of tobacco or nicotine products within 30 days prior to screening
- Degenerative muscular or neurological conditions affecting outcome evaluation (e.g., Parkinson's disease, ALS, multiple sclerosis)
- Medical conditions or treatments that interfere with bone or soft tissue healing such as chronic steroids or ongoing radiation therapy
- Body mass index over 35
- Insulin-dependent diabetes mellitus
- Osteopenia or osteoporosis of the spine with DEXA T score less than or equal to -1.0
- Secondary causes of osteoporosis or other disorders adversely affecting bone formation
- Participation in another investigational study within 30 days for devices or three months for drugs
- History of chemical or alcohol abuse as defined by DSM-5
- Any behavioral, cognitive, social, or medical issues interfering with safety or effectiveness assessments
- Radiographic evidence of compromised vertebral bodies at the index level due to trauma or deformity
- Currently incarcerated
- Involved in active legal claims related to spinal condition or workers compensation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Orthopaedics NorthEast
Fort Wayne, Indiana, United States, 46825
Actively Recruiting
2
Newcastle Private Hospital
Newcastle, New South Wales, Australia, 2305
Actively Recruiting
3
Macquarie University
Sydney, New South Wales, Australia, 2109
Actively Recruiting
Research Team
R
Robyn Cochrane
CONTACT
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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