LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

NCT ID: NCT06462729

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2027-12-31

Brief 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).

Detailed 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 (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.

Conditions

Degenerative Disc Disease; Lumbar Disc Disease; Spine Disease; Lumbar Spine Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LDGraft 0.5mg/cc

Group Type: EXPERIMENTAL

LDGraft

Intervention Type: DEVICE

LDGraft 0.5mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)

LDGraft 1.0mg/cc

Group Type: EXPERIMENTAL

LDGraft

Intervention Type: DEVICE

LDGraft 1.0mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)

Control Allograft Bone

Group Type: ACTIVE_COMPARATOR

Allograft Bone

Intervention Type: OTHER

Allograft bone (100% human tissue product) applied within intervertebral cage with placement of anterior fixation (plate and screws)

Interventions

LDGraft

LDGraft 0.5mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)

Intervention Type: DEVICE

LDGraft

LDGraft 1.0mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)

Intervention Type: DEVICE

Allograft Bone

Allograft bone (100% human tissue product) applied within intervertebral cage with placement of anterior fixation (plate and screws)

Intervention Type: OTHER

Eligibility Criteria

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 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.

4. Preoperative Oswestry Disability Index score ≥ 35

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

6. Participant is indicated for an ALIF approach to the lumbar spine

Exclusion Criteria

1. Previous lumbar spine instrumentation (i.e., anterior disc replacement, interspinous device) or a previous interbody fusion procedure in the lumbar spine

2. More than one level lumbar spine level requiring fusion

3. Three or more contiguous lumbar spine levels requiring decompression (Note: Up to two contiguous levels of decompression is acceptable)

4. 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.

5. Pregnant, planning to become pregnant during the follow-up time period, or breast-feeding women

6. Presence of active malignancy

7. Requires bone growth stimulation in the lumbar spine

8. Active local or systemic infection

9. Spondylolisthesis greater than Grade 1 (25% translation)

10. Currently smoking or using nicotine products, including e-cigarette products (e.g., vaping) (Use within 30 days of screening date is considered 'current')

11. 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

12. 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

13. Body Mass Index > 35

14. Insulin-dependent diabetes mellitus

15. Osteopenia or osteoporosis of the spine, DEXA T score of ≤ -1.0

16. 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)

17. Participation in another investigational study within 30 days prior to surgery for investigational devices, or within the last three months for investigational drugs;

18. Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 (Diagnostic and Statistical Manual) code

19. 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

20. 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

21. Currently a prisoner

22. Involved in active litigation relating to his/her spinal condition or workers compensation claimants.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Locate Bio Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Orthopaedics NorthEast

Fort Wayne, Indiana, United States

Site Status: RECRUITING

Newcastle Private Hospital

Newcastle, New South Wales, Australia

Site Status: RECRUITING

Macquarie University

Sydney, New South Wales, Australia

Site Status: RECRUITING

Countries

United States; Australia

Central Contacts

Robyn Cochrane

Role: CONTACT

rcochrane@locatebio.com

+44 (0)115 784 0041

Facility Contacts

Study Coordinator

Role: primary

tpawlik@orthone.com

260-408-2643

Julie Charlton

Role: primary

julie.charlton@healthscope.com.au

+61 2 4941 8718

Macquarie CTU

Role: primary

clinicaltrials@mq.edu.au

+61 2 9812 2956

Other Identifiers

CI-001

Identifier Type: -

Identifier Source: org_study_id