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LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

PHASE1PHASE2RECRUITING

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).

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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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Degenerative disc disease of the lumbosacral spine in one level (L3 to S1) requiring fusion confirmed by patient history and radiographic imaging (CT/MRI/X-rays) with one or more of the following: instability (as defined by ≥3mm translation or ≥5° angulation); osteophyte formation of facet joints or vertebral endplates; decreased disc height, on average by >2mm, but dependent upon the spinal level; scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule; herniated nucleus pulposus; facet joint degeneration/changes; and/or vacuum phenomenon.

Preoperative Oswestry Disability Index score ≥ 35

Participant has not responded to conservative treatment (e.g. medications, injections, physical therapy, etc.) for a period of 6 months

Participant is indicated for an ALIF approach to the lumbar spine

Exclusion criteria

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.

Pregnant, planning to become pregnant during the follow-up time period, or breast-feeding women

Presence of active malignancy

Requires bone growth stimulation in the lumbar spine

Active local or systemic infection

Spondylolisthesis greater than Grade 1 (25% translation)

Currently smoking or using nicotine products, including e-cigarette products (e.g., vaping) (Use within 30 days of screening date is considered 'current')

Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis

Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids) or receiving radiation therapy that is expected to continue for the duration of the study

Body Mass Index > 35

Insulin-dependent diabetes mellitus

Osteopenia or osteoporosis of the spine, DEXA T score of ≤ -1.0

Any secondary causes of osteoporosis (e.g. chronic liver or kidney disease, uncontrolled hyper- or hypothyroidism, type I or type II diabetes mellitus, gastrointestinal malabsorption syndromes) or other conditions known to adversely affect osteogenesis (e.g. Paget's disease, Ehlers-Danlos syndrome or osteogenesis imperfecta)

Participation in another investigational study within 30 days prior to surgery for investigational devices, or within the last three months for investigational drugs;

Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 (Diagnostic and Statistical Manual) code

In the opinion of the investigator, the participant has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the product

Radiographically compromised vertebral bodies at the index level due to current or past trauma, e.g., by the radiographic appearance of the fracture callus, deformity, malunion or nonunion

Currently a prisoner

Involved in active litigation relating to his/her spinal condition or workers compensation claimants.

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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

OTHER: Allograft Bone

Conditions

• Degenerative Disc Disease
• Lumbar Disc Disease
• Spine Disease
• Lumbar Spine Degeneration

Image related to Degenerative Disc Disease

Condition: Degenerative Disc Disease, Lumbar Disc Disease and more
DEVICE: LDGraft and other drugs
Sydney, New South Wales, Australia and more
Sponsor: Locate Bio Pty Ltd

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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 Not Specified	DEVICE: LDGraft LDGraft 0.5mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)
EXPERIMENTAL: LDGraft 1.0mg/cc Not Specified	DEVICE: LDGraft LDGraft 1.0mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)
ACTIVE_COMPARATOR: Control Allograft Bone Not Specified	OTHER: Allograft Bone Allograft bone (100% human tissue product) applied within intervertebral cage with placement of anterior fixation (plate and screws)

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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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)