RecruitingPhase 1Phase 2NCT06462729

LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

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

Sponsor

Locate Bio Pty Ltd

Enrollment

40 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

Degenerative Disc Disease Lumbar Spine Degeneration Spine Disease Lumbar Disc Disease

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).

Eligibility

Min Age: 22 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Allograft Bone, a medical device called LDGraft, and others for people with degenerative disc disease, lumbar disc disease, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 22 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELDGraft

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

DEVICELDGraft

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

OTHERAllograft Bone

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

Locations(4)

Orthopaedics NorthEast

Fort Wayne, Indiana, United States

Pinehurst Surgical Clinic

Pinehurst, North Carolina, United States

Tennessee Orthopaedic Alliance

Nashville, Tennessee, United States

Newcastle Private Hospital

Newcastle, New South Wales, Australia

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NCT06462729

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