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LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

NCT06462729 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-28

No results posted yet for this study

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

Interventions

DEVICE

LDGraft

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

DEVICE

LDGraft

LDGraft 1.0mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)

OTHER

Allograft Bone

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

Sponsors & Collaborators

  • Locate Bio Pty Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-12
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06462729 on ClinicalTrials.gov