LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

NCT06462729 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: CI-001
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Degenerative Disc Disease; Lumbar Disc Disease; Spine Disease; Lumbar Spine Degeneration

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Radiographic Outcomes

  6 weeks, 3 months, 6 months, 12 months and 24 months

• Visual Analog Score (VAS) Back

  6 weeks, 3 months, 6 months, 12 months and 24 months

• Visual Analog Score (VAS) Change Back

  6 weeks, 3 months, 6 months, 12 months and 24 months

• Visual Analog Score (VAS) Leg

  6 weeks, 3 months, 6 months, 12 months and 24 months

• Visual Analog Score (VAS) Change Leg

  6 weeks, 3 months, 6 months, 12 months and 24 months

Study Arms (3)

LDGraft 0.5mg/cc

EXPERIMENTAL

Device: LDGraft

LDGraft 1.0mg/cc

EXPERIMENTAL

Device: LDGraft

Control Allograft Bone

ACTIVE COMPARATOR

Other: Allograft Bone

Interventions

LDGraft DEVICE

LDGraft 0.5mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)

LDGraft 0.5mg/cc

Allograft Bone OTHER

Allograft bone (100% human tissue product) applied within intervertebral cage with placement of anterior fixation (plate and screws)

Control Allograft Bone

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Locate Bio Pty Ltd: lead

Study Sites (3)

Orthopaedics NorthEast

Fort Wayne, Indiana, 46825, United States

RECRUITING

Newcastle Private Hospital

Newcastle, New South Wales, 2305, Australia

RECRUITING

Macquarie University

Sydney, New South Wales, 2109, Australia

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Intervertebral disc disease; Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Robyn Cochrane

CONTACT

+44 (0)115 784 0041; rcochrane@locatebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the treatment assigned and received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model 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. The study will enrol patients with lumbar degenerative disc disease (DDD) requiring single level ALIF. After a screening period, qualified participants will be enrolled and randomized using a 3:3:2 ratio to receive the LDGraft or the control treatment-allograft bone via spinal surgery and will then complete the safety follow-up period.

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); US (1)