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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 80
Healthy Volunteers: f
View:

• 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 (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 dependent upon the spinal level;

⁃ scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule;

⁃ herniated nucleus pulposus;

⁃ facet joint degeneration/changes; and/or

⁃ vacuum phenomenon.

• Preoperative Oswestry Disability Index score ≥ 35

• Participant has not responded to conservative treatment (e.g. medications, injections, physical therapy, etc.) for a period of 6 months

• Participant is indicated for an ALIF approach to the lumbar spine

Locations
Other Locations
Australia
Newcastle Private Hospital
RECRUITING
Newcastle
Macquarie University
RECRUITING
Sydney
Contact Information
Primary
Robyn Cochrane
rcochrane@locatebio.com
+44 (0)115 784 0041
Time Frame
Start Date: 2024-11-12
Estimated Completion Date: 2027-12
Participants
Target number of participants: 40
Treatments
Experimental: LDGraft 0.5mg/cc
Experimental: LDGraft 1.0mg/cc
Active_comparator: Control Allograft Bone
Related Therapeutic Areas
Sponsors
Leads: Locate Bio Pty Ltd

This content was sourced from clinicaltrials.gov