LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) (RESTORE)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Degenerative Disc Disease; Lumbar Disc Disease; Spine Disease; Lumbar Spine Degeneration
• Intervention / Treatment: Device: LDGraft; Device: LDGraft; Other: Allograft Bone

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Robyn Cochrane; Phone Number: +44 (0)115 784 0041; Email: rcochrane@locatebio.com

Study Locations

• Australia
  • New South Wales
    • Newcastle, New South Wales, Australia, 2305
      • Recruiting
      • Newcastle Private Hospital
      • Contact: Julie Charlton; Phone Number: +61 2 4941 8718; Email: julie.charlton@healthscope.com.au
      • Principal Investigator: Mitchell Hansen, BSc MBBS PhD
• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Recruiting
      • Orthopaedics NorthEast
      • Contact: Study Coordinator; Phone Number: 260-408-2643; Email: tpawlik@orthone.com
      • Principal Investigator: Micah Smith, MD
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • Recruiting
      • Pinehurst Surgical Clinic
      • Principal Investigator: Daniel Williams, MD
      • Contact: Nicole Goolsby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LDGraft 0.5mg/cc	Device: LDGraft; LDGraft 0.5mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws); Device: LDGraft; LDGraft 1.0mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)
Experimental: LDGraft 1.0mg/cc	Device: LDGraft; LDGraft 0.5mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws); Device: LDGraft; LDGraft 1.0mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)
Active Comparator: Control Allograft Bone	Other: Allograft Bone; Allograft bone (100% human tissue product) applied within intervertebral cage with placement of anterior fixation (plate and screws)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Fusion	Radiographic fusion defined as evidence of bridging bone by CT scan	12 months and 24 months
Secondary Surgical Intervention	No index level secondary surgical intervention	12 months and 24 months
Oswestry Disability Index (ODI) Score	At least 15-point improvement in Oswestry Disability Index (ODI) compared to baseline	12 months and 24 months
Neurological Condition	No new or worsening persistent lumbar spine neurological condition compared to baseline	12 months and 24 months
Serious Device-Related Adverse Events	No serious device-related adverse events	12 months and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Outcomes	Radiographic outcomes including bridging bone, radiolucency, device condition, migration, subsidence, angular motion, and translational motion	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	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	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	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	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	6 weeks, 3 months, 6 months, 12 months and 24 months
Oswestry Disability Index (ODI) Change	Mean change in ODI over time intervals	6 weeks, 3 months, 6 months, 12 months and 24 months

Collaborators and Investigators

• Sponsor: Locate Bio Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Intervertebral Disc Degeneration; Spinal Diseases; Intervertebral disc disease
• Other Study ID Numbers: CI-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No