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New treatment option for Degenerative Disc Disease
Official title LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
ClinicalTrials.gov ID: NCT06462729
What this study is testing
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 80
You may be able to join 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...
- instability (as defined by ≥3mm translation or ≥5° angulation);
- osteophyte formation of facet joints or vertebral endplates;
You likely can't join if
- Previous lumbar spine instrumentation (i.e., anterior disc replacement, interspinous device) or a previous interbody fusion procedure in the lumbar...
- 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...
- Pregnant, planning to become pregnant during the follow-up time period, or breast-feeding women
- Presence of active malignancy
See the full eligibility criteria
- 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
- 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...
- 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...
- 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 how well it works 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fort Wayne, Indiana, United States
- Pinehurst, North Carolina, United States
- Newcastle, New South Wales, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Wayne, Indiana, United States; Pinehurst, North Carolina, United States; Newcastle, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.