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LDGraft for Degenerative Disc Disease in Lumbar Spine Fusion

This study is testing a new device called LDGraft for people with degenerative disc disease (wear and tear of the spinal discs) in their lower back. It compares two different strengths of LDGraft (0.5mg/cc and 1.0mg/cc) to a standard treatment called allograft bone (human tissue product) during a single-level anterior lumbar interbody fusion (ALIF) surgery. This surgery involves placing a cage with the treatment material and then adding a plate and screws for stability. The main goals are to see how well the spine bones fuse together and if you need any additional surgeries after 12 and 24 months. Researchers will also look at how your disability score changes. You might be able to join if you are between 22 and 80 years old and need this type of spinal fusion.

Study design
This is a randomized, controlled study involving 40 participants across multiple centers. Participants will be assigned to one of three groups (two LDGraft groups or one allograft group) without knowing which treatment they receive.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after their surgery to assess fusion, need for additional surgery, and disability scores.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06462729

LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

Recruiting
PHASE1Ages 22–80InterventionalTreatment
Locate Bio Pty Ltd
~40 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:LDGraftAllograft Bone

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiographic Fusion
Measured over 12 months and 24 months
+4 more outcomes measured

Conditions

Degenerative Disc Disease
Lumbar Disc Disease
Spine Disease
Lumbar Spine Degeneration

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Intervertebral Disc Degenerative Disorder

NCT06462729

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Newcastle Private Hospital

    Newcastle, New South Wales, Australiastudy coordinator listed

    Recruiting

  • Orthopaedics NorthEast

    Fort Wayne, Indianastudy coordinator listed

    Recruiting

  • Pinehurst Surgical Clinic

    Pinehurst, North Carolinano site contact published

    Recruiting

  • Tennessee Orthopaedic Alliance

    Nashville, Tennesseeno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Robyn Cochrane
[email protected]
+44 (0)115 784 0041
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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. 4. Preoperative Oswestry Disability Index score ≥ 35 5. Participant has not responded to conservative treatment (e.g. medications, injections, physical therapy, etc.) for a period of 6 months 6. Participant is indicated for an ALIF approach to the lumbar spine

What this trial measures

  • Radiographic Fusion12 months and 24 months

    Radiographic fusion defined as evidence of bridging bone by CT scan

  • Secondary Surgical Intervention12 months and 24 months

    No index level secondary surgical intervention

  • Oswestry Disability Index (ODI) Score12 months and 24 months

    At least 15-point improvement in Oswestry Disability Index (ODI) compared to baseline

  • Neurological Condition12 months and 24 months

    No new or worsening persistent lumbar spine neurological condition compared to baseline

  • Serious Device-Related Adverse Events12 months and 24 months

    No serious device-related adverse events