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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
LDGraft 0.5mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)
LDGraft 1.0mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)
Allograft bone (100% human tissue product) applied within intervertebral cage with placement of anterior fixation (plate and screws)
Orthopaedics NorthEast
Fort Wayne, Indiana, United States
RECRUITINGPinehurst Surgical Clinic
Pinehurst, North Carolina, United States
RECRUITINGNewcastle Private Hospital
Newcastle, New South Wales, Australia
RECRUITINGRadiographic Fusion
Radiographic fusion defined as evidence of bridging bone by CT scan
Time frame: 12 months and 24 months
Secondary Surgical Intervention
No index level secondary surgical intervention
Time frame: 12 months and 24 months
Oswestry Disability Index (ODI) Score
At least 15-point improvement in Oswestry Disability Index (ODI) compared to baseline
Time frame: 12 months and 24 months
Neurological Condition
No new or worsening persistent lumbar spine neurological condition compared to baseline
Time frame: 12 months and 24 months
Serious Device-Related Adverse Events
No serious device-related adverse events
Time frame: 12 months and 24 months
Radiographic Outcomes
Radiographic outcomes including bridging bone, radiolucency, device condition, migration, subsidence, angular motion, and translational motion
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Visual Analog Score (VAS) Back
Improvement in the Visual Analog Score (VAS) back pain of 20mm compared to baseline
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Visual Analog Score (VAS) Change Back
Mean change in back VAS over time intervals
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Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Visual Analog Score (VAS) Leg
Improvement in the Visual Analog Score (VAS) worst leg of 20mm compared to baseline
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Visual Analog Score (VAS) Change Leg
Mean change in leg VAS over time intervals
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Oswestry Disability Index (ODI) Score
Improvement in ODI of 15 points compared to baseline
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Oswestry Disability Index (ODI) Change
Mean change in ODI over time intervals
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months