A Randomized Study of LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
Locate Bio Pty Ltd
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).
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 (investigati…
Eligibility
- Age range
- 22–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Skeletally mature adults ≥22 and ≤80 years at the time of surgery 2. Willing and able to give written informed consent and comply with study protocol and postoperative management program 3. 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…
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 (3)
- Orthopaedics NorthEastFort Wayne, Indiana
- Newcastle Private HospitalNewcastle, New South Wales
- Macquarie UniversitySydney, New South Wales