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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06462729




Registration number
NCT06462729
Ethics application status
Date submitted
12/06/2024
Date registered
17/06/2024

Titles & IDs
Public title
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
Scientific title
A Randomized Study of LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
Secondary ID [1] 0 0
CI-001
Universal Trial Number (UTN)
Trial acronym
RESTORE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative Disc Disease 0 0
Lumbar Disc Disease 0 0
Spine Disease 0 0
Lumbar Spine Degeneration 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - LDGraft
Treatment: Devices - LDGraft
Other interventions - Allograft Bone

Experimental: LDGraft 0.5mg/cc -

Experimental: LDGraft 1.0mg/cc -

Active comparator: Control Allograft Bone -


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

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

Other interventions: Allograft Bone
Allograft bone (100% human tissue product) applied within intervertebral cage with placement of anterior fixation (plate and screws)
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Fusion
Timepoint [1] 0 0
12 months and 24 months
Primary outcome [2] 0 0
Secondary Surgical Intervention
Timepoint [2] 0 0
12 months and 24 months
Primary outcome [3] 0 0
Oswestry Disability Index (ODI) Score
Timepoint [3] 0 0
12 months and 24 months
Primary outcome [4] 0 0
Neurological Condition
Timepoint [4] 0 0
12 months and 24 months
Primary outcome [5] 0 0
Serious Device-Related Adverse Events
Timepoint [5] 0 0
12 months and 24 months
Secondary outcome [1] 0 0
Radiographic Outcomes
Timepoint [1] 0 0
6 weeks, 3 months, 6 months, 12 months and 24 months
Secondary outcome [2] 0 0
Visual Analog Score (VAS) Back
Timepoint [2] 0 0
6 weeks, 3 months, 6 months, 12 months and 24 months
Secondary outcome [3] 0 0
Visual Analog Score (VAS) Change Back
Timepoint [3] 0 0
6 weeks, 3 months, 6 months, 12 months and 24 months
Secondary outcome [4] 0 0
Visual Analog Score (VAS) Leg
Timepoint [4] 0 0
6 weeks, 3 months, 6 months, 12 months and 24 months
Secondary outcome [5] 0 0
Visual Analog Score (VAS) Change Leg
Timepoint [5] 0 0
6 weeks, 3 months, 6 months, 12 months and 24 months
Secondary outcome [6] 0 0
Oswestry Disability Index (ODI) Score
Timepoint [6] 0 0
6 weeks, 3 months, 6 months, 12 months and 24 months
Secondary outcome [7] 0 0
Oswestry Disability Index (ODI) Change
Timepoint [7] 0 0
6 weeks, 3 months, 6 months, 12 months and 24 months

Eligibility
Key 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
Minimum age
22 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Newcastle Private Hospital - Newcastle
Recruitment hospital [2] 0 0
Macquarie University - Sydney
Recruitment postcode(s) [1] 0 0
2305 - Newcastle
Recruitment postcode(s) [2] 0 0
2109 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Locate Bio Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Robyn Cochrane
Address 0 0
Country 0 0
Phone 0 0
+44 (0)115 784 0041
Fax 0 0
Email 0 0
rcochrane@locatebio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06462729