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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

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

      PHASE2

    trial

    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
    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

    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

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    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/ArmIntervention/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 MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Radiographic FusionRadiographic fusion defined as evidence of bridging bone by CT scan12 months and 24 months
    Secondary Surgical InterventionNo index level secondary surgical intervention12 months and 24 months
    Oswestry Disability Index (ODI) ScoreAt least 15-point improvement in Oswestry Disability Index (ODI) compared to baseline12 months and 24 months
    Neurological ConditionNo new or worsening persistent lumbar spine neurological condition compared to baseline12 months and 24 months
    Serious Device-Related Adverse EventsNo serious device-related adverse events12 months and 24 months

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Radiographic OutcomesRadiographic outcomes including bridging bone, radiolucency, device condition, migration, subsidence, angular motion, and translational motion6 weeks, 3 months, 6 months, 12 months and 24 months
    Visual Analog Score (VAS) BackImprovement in the Visual Analog Score (VAS) back pain of 20mm compared to baseline6 weeks, 3 months, 6 months, 12 months and 24 months
    Visual Analog Score (VAS) Change BackMean change in back VAS over time intervals6 weeks, 3 months, 6 months, 12 months and 24 months
    Visual Analog Score (VAS) LegImprovement in the Visual Analog Score (VAS) worst leg of 20mm compared to baseline6 weeks, 3 months, 6 months, 12 months and 24 months
    Visual Analog Score (VAS) Change LegMean change in leg VAS over time intervals6 weeks, 3 months, 6 months, 12 months and 24 months
    Oswestry Disability Index (ODI) ScoreImprovement in ODI of 15 points compared to baseline6 weeks, 3 months, 6 months, 12 months and 24 months
    Oswestry Disability Index (ODI) ChangeMean change in ODI over time intervals6 weeks, 3 months, 6 months, 12 months and 24 months

    Frequently Asked Questions

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    References

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

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