NCT06462729

LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

A Randomized Study of LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Locate Bio Pty Ltd · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-11-12
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-06-17
• Last updated: 2026-01-28

Locations

3 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated device study