P-15L Bone Graft Lumbar Fusion Clinical Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Back Pain, Neurology, Orthopedic |
| Therapuetic Areas: | Musculoskeletal, Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 22 - 75 |
| Updated: | 8/24/2018 |
| Start Date: | August 1, 2018 |
| End Date: | December 31, 2019 |
| Contact: | Surabhi Bhatt, BS |
| Email: | surabhi.bhatt@nm.org |
| Phone: | 312-472-6024 |
An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
Study Design: Prospective, single-blinded, multi-center, randomized, controlled, pivotal
study Study Objective: To evaluate if P-15L is not inferior in effectiveness and safety to
local autologous bone (and allograft as extender where necessary) when applied in
instrumented TLIF in subjects with Degenerative disc disease (DDD)
Study Endpoints:
Primary endpoint: Month 24 Composite Clinical Success (CCS):
- Achievement of fusion (Evidence of continuous trabecular bridging bone in the
intervertebral space)
- At least 15-point improvement in Oswestry Disability Index (ODI)
- No new or worsening, persistent neurological deficit
- No subsequent surgical intervention at the index level
Once fusion is radiographically confirmed, it will be assumed that fusion has occurred at all
subsequent time points without the need to reconfirm fusion status at later time points.
Multiplicity Controlled Secondary endpoint:
• Visit at which fusion is confirmed.
Other Secondary endpoints:
- Visual Analog Scale (VAS) pain scores, changes over time, and achievement of a 20 mm
improvement (Back, left leg, right leg);
- Physical Function and Mental Health Composite Scores (Short Form Health Survey SF-12 and
changes over time).
study Study Objective: To evaluate if P-15L is not inferior in effectiveness and safety to
local autologous bone (and allograft as extender where necessary) when applied in
instrumented TLIF in subjects with Degenerative disc disease (DDD)
Study Endpoints:
Primary endpoint: Month 24 Composite Clinical Success (CCS):
- Achievement of fusion (Evidence of continuous trabecular bridging bone in the
intervertebral space)
- At least 15-point improvement in Oswestry Disability Index (ODI)
- No new or worsening, persistent neurological deficit
- No subsequent surgical intervention at the index level
Once fusion is radiographically confirmed, it will be assumed that fusion has occurred at all
subsequent time points without the need to reconfirm fusion status at later time points.
Multiplicity Controlled Secondary endpoint:
• Visit at which fusion is confirmed.
Other Secondary endpoints:
- Visual Analog Scale (VAS) pain scores, changes over time, and achievement of a 20 mm
improvement (Back, left leg, right leg);
- Physical Function and Mental Health Composite Scores (Short Form Health Survey SF-12 and
changes over time).
Cerapedics currently markets a peptide-enhanced bone graft product, i-FACTOR putty, for use
in cervical spine degenerative disk disease. i-FACTOR putty is a composite bone substitute
material consisting of the P-15 peptide adsorbed onto anorganic bone mineral and suspended in
an inert biocompatible hydrogel carrier. P-15 is a synthetic, 15-amino acid peptide that
mimics the cellbinding domain of Type I collagen and is able to signal a mechanical and
biochemical communication pathway that ultimately results in new bone formation. The P-15
peptide enhances cell migration and induces osteoblast cell proliferation and
differentiation. P-15 is specific to anchoring-dependent connective tissue mesenchymal cells,
including osteogenic cells,and therefore does not induce bone formation in the absence of
these cells. The receptor mediated anchorage of osteoblasts by P-15 initiates a number of
signal transduction pathways that lead to the synthesis of growth factors, cytokines, and
bone morphogenetic proteins.
A prospective, randomized, controlled, multi-center clinical trial in cervical spinal fusion
demonstrated the safety and efficacy of i-FACTOR putty compared to standard-of-care autograft
(clinicaltrials.gov NCT00310440.) The results demonstrated that i-FACTOR putty was
statistically non-inferior to autograft for fusion success, improvement in Neck Disability
Index (NDI) scores, neurological success and number of adverse events, at both the 1 and 2
year time point. The i-FACTOR putty was demonstrated to be statistically superior to
autograft, at both 1 year and 2-years, for "overall success" which measures the patients that
were successful in all of the test modalities.
Cerapedics is developing a new bone graft product formulation to enhance our product
portfolio, specifically a P15-based bone graft that is appropriate for lumbar spinal fusion,
called P-15L. The new formulation comprises two new materials as compared to the original
i-FACTOR putty. The first is the use of porcine-derived anorganic bone mineral (ABM) as the
anorganic bone matrix. The second modification is the use of bovine collagen as the inert
carrier for the anorganic bone granules. The introduction of collagen as the inert carrier
will allow the P-15L to be used in a TLIF surgical indication since the collagen component
provides material integrity for the putty in the implant site.
in cervical spine degenerative disk disease. i-FACTOR putty is a composite bone substitute
material consisting of the P-15 peptide adsorbed onto anorganic bone mineral and suspended in
an inert biocompatible hydrogel carrier. P-15 is a synthetic, 15-amino acid peptide that
mimics the cellbinding domain of Type I collagen and is able to signal a mechanical and
biochemical communication pathway that ultimately results in new bone formation. The P-15
peptide enhances cell migration and induces osteoblast cell proliferation and
differentiation. P-15 is specific to anchoring-dependent connective tissue mesenchymal cells,
including osteogenic cells,and therefore does not induce bone formation in the absence of
these cells. The receptor mediated anchorage of osteoblasts by P-15 initiates a number of
signal transduction pathways that lead to the synthesis of growth factors, cytokines, and
bone morphogenetic proteins.
A prospective, randomized, controlled, multi-center clinical trial in cervical spinal fusion
demonstrated the safety and efficacy of i-FACTOR putty compared to standard-of-care autograft
(clinicaltrials.gov NCT00310440.) The results demonstrated that i-FACTOR putty was
statistically non-inferior to autograft for fusion success, improvement in Neck Disability
Index (NDI) scores, neurological success and number of adverse events, at both the 1 and 2
year time point. The i-FACTOR putty was demonstrated to be statistically superior to
autograft, at both 1 year and 2-years, for "overall success" which measures the patients that
were successful in all of the test modalities.
Cerapedics is developing a new bone graft product formulation to enhance our product
portfolio, specifically a P15-based bone graft that is appropriate for lumbar spinal fusion,
called P-15L. The new formulation comprises two new materials as compared to the original
i-FACTOR putty. The first is the use of porcine-derived anorganic bone mineral (ABM) as the
anorganic bone matrix. The second modification is the use of bovine collagen as the inert
carrier for the anorganic bone granules. The introduction of collagen as the inert carrier
will allow the P-15L to be used in a TLIF surgical indication since the collagen component
provides material integrity for the putty in the implant site.
Inclusion Criteria:
- Skeletally mature adults between 22 and 75 years old (inclusive);
- Back pain with radicular symptoms as evidenced by leg pain, confirmed by history and
physical exam
- Radiographically determined discogenic origin of the pain demonstrating at least one
of the following characteristics: Degenerated/dark disc on MRI, instability
(angulation ≥ 5° and/or translation ≥ 3mm on flexion/extension radiographs),
osteophyte formation, ligamentous thickening, decreased disc height compared to
adjacent levels on radiographic film, CT, or MRI, and disc herniation on CT or MRI
- Oswestry Low Back Pain Disability Questionnaire score of ≥ 35
- Involved disc(s) between L2 and S1
- Planned lumbar fusion at a single level only
- Failed to gain adequate relief from at least 6 months of adequate non-operative
treatment;
- Able and willing to give consent to participate in study;
- Willing and able to participate in the study follow-up according to the protocol;
- Willing and able to comply with postoperative management program;
Exclusion Criteria:
- Systemic infection such as AIDS, HIV, and active hepatitis;
- Autoimmune disease
- Significant metabolic disease that in the surgeon's opinion might compromise bone
growth such as osteoporosis, osteopenia, or osteomalacia
- Taking medication for the prevention of osteoporosis or other medications that may
interfere with fusion (e.g. steroids, or has received drugs that interfere with bone
metabolism within 2 weeks of surgery)
- Circulatory, cardiac, or pulmonary problems that could cause excessive surgical risk
- Active malignancy
- Nondiscogenic source of symptoms (e.g. tumor, etc.)
- Multiple level symptomatic degenerative disc disease
- Previous spinal instrumentation or a previous interbody fusion procedure at the
involved level Isthmic Spondylolisthesis
- Spondylolisthesis ≥ grade 2 if present
- Active local or systemic infection
- Known allergy to components within P-15L bone graft including bovine collagen
- PEEK, or materials in supplemental fixation systems
- Pregnant or planning to become pregnant in the next 2 years
- More than one level to be operated
- Has a history of substance abuse (e.g. recreational drugs, alcohol)
- Is a prisoner
- Is currently involved in a study of another investigational product for similar
purpose
- Has a disease process that would preclude accurate evaluation (e.g. neuromuscular
disease, significant psychiatric disease);
- Has active or recent (within the past 2 years) Worker's compensation litigation.
- Any condition that would interfere with the subject's ability to comply with the study
related requirements.
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