LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

Recruiting now · Phase 1/Phase 2

Conditions studied: Degenerative Disc Disease, Lumbar Disc Disease, Spine Disease, Lumbar Spine Degeneration

In brief

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).

Key facts

Study ID

NCT06462729

Run by

Locate Bio Pty Ltd

People needed

40

Starts

2024-11-12

Expected to finish

2027-12-01

Last updated by the study team

2026-05-27

Who can join

Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 (Note: Up to two contiguous levels of decompression is acceptable)
• 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.
• Pregnant, planning to become pregnant during the follow-up time period, or breast-feeding women
• Presence of active malignancy
• Requires bone growth stimulation in the lumbar spine
• Active local or systemic infection
• Spondylolisthesis greater than Grade 1 (25% translation)
• Currently smoking or using nicotine products, including e-cigarette products (e.g., vaping) (Use within 30 days of screening date is considered 'current')
• Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis
• Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids) or receiving radiation therapy that is expected to continue for the duration of the study
• Body Mass Index > 35
• Insulin-dependent diabetes mellitus
• Osteopenia or osteoporosis of the spine, DEXA T score of ≤ -1.0
• Any secondary causes of osteoporosis (e.g. chronic liver or kidney disease, uncontrolled hyper- or hypothyroidism, type I or type II diabetes mellitus, gastrointestinal malabsorption syndromes) or other conditions known to adversely affect osteogenesis (e.g. Paget's disease, Ehlers-Danlos syndrome or osteogenesis imperfecta)
• Participation in another investigational study within 30 days prior to surgery for investigational devices, or within the last three months for investigational drugs;
• Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 (Diagnostic and Statistical Manual) code
• In the opinion of the investigator, the participant has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the product
• Radiographically compromised vertebral bodies at the index level due to current or past trauma, e.g., by the radiographic appearance of the fracture callus, deformity, malunion or nonunion
• Currently a prisoner
• Involved in active litigation relating to his/her spinal condition or workers compensation claimants.

Where it is running

• Orthopaedics NorthEast — Fort Wayne, Indiana, United States (enrolling)
• Pinehurst Surgical Clinic — Pinehurst, North Carolina, United States (enrolling)
• Newcastle Private Hospital — Newcastle, New South Wales, Australia (enrolling)

Full record on ClinicalTrials.gov

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