LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

Degenerative Disc Disease Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06462729
• Other study ID #: CI-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 2024
• Est. completion date: July 2027

Study information

• Verified date: June 2024
• Source: Locate Bio Ltd
• Contact: Robyn Cochrane
• Phone: +44 (0)115 784 0041
• Email: rcochrane[@]locatebio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Lumbar Disc Disease
• Lumbar Spine Degeneration
• Spinal Diseases
• Spine Disease

Intervention

Device:
• LDGraft
LDGraft 0.5mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)
• LDGraft
LDGraft 1.0mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)

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

Locations

Country	Name	City	State
Australia	Newcastle Private Hospital	Newcastle	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Locate Bio Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Fusion	Radiographic fusion defined as evidence of bridging bone by CT scan	12 months and 24 months
Primary	Secondary Surgical Intervention	No index level secondary surgical intervention	12 months and 24 months
Primary	Oswestry Disability Index (ODI) Score	At least 15-point improvement in Oswestry Disability Index (ODI) compared to baseline	12 months and 24 months
Primary	Neurological Condition	No new or worsening persistent lumbar spine neurological condition compared to baseline	12 months and 24 months
Primary	Serious Device-Related Adverse Events	No serious device-related adverse events	12 months and 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Oswestry Disability Index (ODI) Change	Mean change in ODI over time intervals	6 weeks, 3 months, 6 months, 12 months and 24 months