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P-15L Bone Graft Lumbar Fusion Clinical Trial

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ClinicalTrials.gov Identifier: NCT03502057
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
CeraPedics, Inc
Information provided by (Responsible Party):
Wellington Hsu, Northwestern University

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Radiculopathy Lumbar Back Pain With Radiation Device: P-15L Device: Control Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: Investigational group

Treated by instrumented transforaminal lumbar interbody fusion (TLIF).

Fusion will include placement of any static PEEK cage, FDA cleared for TLIF with the central cavity filled in with P-15L; in addition, the interdiscal space around the cage is to be filled to the greatest extent possible.

Bilateral posterior pedicle screw fixation is required.

The procedure will not include decortication and/or grafting in the posterolateral gutters.

Device: P-15L
P-15L is a composite bone graft material consisting of multiple components - a synthetic peptide (P-15) adsorbed onto calcium phosphate particles, which are suspended in a collagen carrier. The P-15L Bone Graft is indicated for intervertebral body fusion of the spine in skeletally mature patients. The P-15L Bone Graft is intended to be used in conjunction with a PEEK TLIF Fusion Device and posterior pedicle screw fixation cleared by the FDA for use in the lumbosacral spine.The system is to be used in patients who have had at least six months of non-operative treatment.The P-15L Bone Graft is intended for use at one level in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Placebo Comparator: Control group

Treated via TLIF.

Fusion will include placement of a static FDA cleared Transforaminal lumbar interbody fusion (TLIF) Polyetheretherketone (PEEK) cage with the central cavity filled with local autologous bone harvested from millings and osteophytes.

The remainder of the interdiscal space should be filled around the cage to the greatest extent possible.

Device: Control
Local autologous bone (mixed with an American Association of Tissue Banks (AATB) accredited cancellous allograft chip substitute when insufficient volumes of autograft are available)




Primary Outcome Measures :
  1. Achievement of fusion (Evidence of continuous trabecular bridging bone in the intervertebral space) through lumbar CT [ Time Frame: 24 months post-op ]
    Lumbar spine CT

  2. At least 15-point improvement in Oswestry Disability Index (ODI) [ Time Frame: 24 months post-op ]
    Questionnaire used to quantify disability for low back pain

  3. No subsequent surgical intervention at the index level through comprehensive examinations of revision [ Time Frame: 24 months post-op ]
    Revision rates

  4. No subsequent surgical intervention at the index level through comprehensive examinations of removal [ Time Frame: 24 months post-op ]
    Removal rates

  5. No subsequent surgical intervention at the index level through comprehensive examinations of re operation [ Time Frame: 24 months post-op ]
    Re-operation rates

  6. No subsequent surgical intervention at the index level through comprehensive examinations of supplemental fixation rates [ Time Frame: 24 months post-op ]
    Supplemental fixation rates

  7. No new or worsening, persistent neurological deficit through a clinical exam involving Knee and ankle reflex testing [ Time Frame: Neurodynamic tests to check the mechanical movement of the neurological tissues as well as their sensitivity to mechanical stress or compression. ]
    Neurodynamic tests to check the mechanical movement of the neurological tissues as well as their sensitivity to mechanical stress or compression.

  8. No new or worsening, persistent neurological deficit through a clinical exam involving Straight-leg raise test [ Time Frame: 24 months post-op ]
    Neurodynamic tests to check the mechanical movement of the neurological tissues as well as their sensitivity to mechanical stress or compression.

  9. No new or worsening, persistent neurological deficit through a clinical exam involving Sensory and motor function assessment. [ Time Frame: Neurodynamic tests to check the mechanical movement of the neurological tissues as well as their sensitivity to mechanical stress or compression. ]
    Neurodynamic tests to check the mechanical movement of the neurological tissues as well as their sensitivity to mechanical stress or compression.


Secondary Outcome Measures :
  1. Visit at which fusion is confirmed through lumbar spine CT and radiographs [ Time Frame: 24 months post-op ]
    Lumbar spine CT and radiographs

  2. Visit at which fusion is confirmed through lumbar spine radiographs [ Time Frame: 24 months post-op ]
    Lumbar spine radiographs

  3. Visual Analog Scale (VAS) pain scores (0-10 scale, 0 = no pain, 10 = worst pain imaginable), changes over time, and achievement of a 20mm improvement (Back, left leg, right leg) [ Time Frame: Pre-op, 6 weeks post-op, 3 months post-op, 6 months post-op, 12 months post-op, 24 months post-op, 36 months post-op, 48 months post-op, 60 months post-op, 72 months post-op ]
    Uni-dimensional measure of pain intensity from 0 to 10

  4. Physical Function Scores (12-Item Short Form Health Survey (SF-12) and changes over time); a higher SF-12 score is better. [ Time Frame: Pre-op, 6 months post-op, 12 months post-op, 24 months post-op, 36 months post-op, 48 months post-op, 60 months post-op, 72 months post-op ]
    Physical Function calculated through SF-12

  5. Mental Health Composite Scores (12-Item Short Form Health Survey (SF-12) and changes over time); a higher SF-12 score is better. [ Time Frame: Pre-op, 6 months post-op, 12 months post-op, 24 months post-op, 36 months post-op, 48 months post-op, 60 months post-op, 72 months post-op ]
    Mental Health Score calculated through SF-12



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502057


Contacts
Contact: Surabhi Bhatt, BS 312-472-6024 surabhi.bhatt@nm.org
Contact: Elijah Ogunkoya, BS 312-695-0332 elijah.ogunkoya@nm.org

Locations
United States, Illinois
Northwestern Medicine Department of Orthopaedic Surgery Recruiting
Chicago, Illinois, United States, 60611
Contact: Blair Faber    312-695-3248    BFaber@nm.org   
Contact: Lisa Rios    312-472-6095    lrios@nm.org   
Northwestern Medicine, Department of Orthopaedic Surgery Recruiting
Chicago, Illinois, United States, 60611
Contact: Surabhi Bhatt    312-472-6024    surabhi-bhatt@northwestern.edu   
Sponsors and Collaborators
Northwestern University
CeraPedics, Inc

Responsible Party: Wellington Hsu, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03502057     History of Changes
Other Study ID Numbers: STU00207016
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Back Pain
Intervertebral Disc Degeneration
Radiculopathy
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases