A Study of LDGraft In Single Level Lumbar Interbody Fusion
ConditionDegenerative Disc Disease Lumbar
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age22-80
SponsorLocate Bio Ltd
About this trial
The objective of the study is to evaluate the safety and effectiveness of LDGraft (investigational device) when applied in a lumbar interbody fusion procedure in the treatment of patients with lumbar Degenerative Disc Disease (DDD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Skeletally mature adults ≥22 and ≤80 years at the time of surgery
Willing and able to give written informed consent and comply with study protocol and postoperative management program
Degenerative disc disease of the lumbosacral spine in one level requiring fusion confirmed by patient history and radiographic imaging
Preoperative Oswestry Disability Index score ≥ 35
Disqualifiers
Previous lumbar spine instrumentation (i.e., anterior disc replacement, interspinous device) or a previous interbody fusion procedure in the lumbar spine
More than one level lumbar spine level requiring fusion
Three or more contiguous lumbar spine levels requiring decompression
Known hypersensitivity or allergy to any components of the study treatments inclusive of hypersensitivity or allergy to any BMP-2 type recombinant proteins or peptides.
Trial design
Design model
Single group
Treatments tested in this trial
LDGraft
Combination productLDGraft (b-TCP / rhBMP-2) bone graft substitute
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: LDGraftExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Secondary Surgical Intervention (SSI)
No index level secondary surgical intervention reported
Time frame
6-month and 12-month follow up2
Radiographic Fusion
Radiographic fusion derived from bridging bone, angular motion and translational motion assessment via CT
Time frame
6-month and 12-month follow up3
Oswestry Disability Index (ODI) Improvement
At least 15 point improvement in ODI compared to baseline
Time frame
6-month and 12-month follow up4
No new or worsening lumbar spine neurological condition
No new or worsening lumbar spine neurological condition compared to baseline
Time frame
6-month and 12-month follow upSecondary outcomes
1
Visual Analog Score (VAS) Leg Improvement
20mm improvement compared to baseline
Time frame
6-week, 3-month, 6-month and 12-month follow up2
Visual Analog Score (VAS) Back Improvement
20mm improvement compared to baseline
Time frame
6-week, 3-month, 6-month and 12-month follow up3
Oswestry Disability Index (ODI) Change
Mean change over time intervals
Time frame
6-week, 3-month, 6-month and 12 month follow up4
Visual Analog Score (VAS) Leg Change
Mean change over time intervals
Time frame
6-week, 3-month, 6-month and 12-month follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov