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Pilot Study to Assess Safety/Prelimary Effectiveness of Prefix in Subjects With Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery

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ClinicalTrials.gov Identifier: NCT00798239
Recruitment Status : Unknown
Verified March 2012 by BioSurface Engineering Technologies, Inc.
Recruitment status was:  Active, not recruiting
First Posted : November 26, 2008
Last Update Posted : March 9, 2012
Sponsor:
Information provided by (Responsible Party):
BioSurface Engineering Technologies, Inc

Brief Summary:
This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from L2-S1.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Spondylolisthesis Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules Other: Iliac crest autograft Phase 1 Phase 2

Detailed Description:
Not available

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective, Parallel Group, Randomized, Pilot Study Evaluating Safety and Preliminary Effectiveness Of Prefix Compared To Iliac Crest Bone In Subjects With DDD Undergoing Transforaminal Lumbar Interbody Fusion
Study Start Date : November 2008
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
The control arm is Iliac Crest Autograft
Other: Iliac crest autograft
autograft

Experimental: Prefix 150
Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules
Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules
150 micorgrams/cc BVF
Other Name: AMPLEX

Experimental: Prefix 750
Prefix (AMPLEX) B2A Enhanced Ceramic Granules
Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules
750 micrograms/cc BVF
Other Name: AMPLEX




Primary Outcome Measures :
  1. Removal/revision or supplemental fixation of the graft material requiring reoperation at the index level, Safety (adverse events), Fusion "success" based on X-rays, Change from baseline in neurological exam scores and ODI scores [ Time Frame: 12 months post surgery ]

Secondary Outcome Measures :
  1. Volume of blood loss/transfused blood during surgery, Blinded independent assessment of fusion by CT and other radiographic assessments, Change from baseline in pain scores using VAS and change from baseline in SF-36 v2™ total and subscale scores [ Time Frame: 12 months post surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of DDD requiring single level fusion (L2-S1) with up to Grade I Spondylolisthesis
  • Have a preoperative screening qualifying VAS and ODI scores
  • Be a skeletally mature male or a non-pregnant, non-lactating female, age 18 -70 inclusive
  • Have not been sufficiently responsive to at least 6 months of non-operative treatment prior to study enrollment

Exclusion Criteria:

  • Are female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following the surgery
  • A history of previous surgery in the lumbar spine with or without attempted fusion
  • Grade II or greater spondylolisthesis
  • More than 0 degrees of kyphosis at the operated disc space
  • Evidence of scoliosis in the lumbar region of more than 10 degrees
  • Collapsed disc space with bridging osteophytes
  • A systemic or local infection at the site of surgery
  • An acute fracture of the spine at the time of enrollment in the study
  • An active history of systemic malignancy
  • A medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study
  • A known hypersensitivity to any of the components of the product or a known titanium allergy or a known allergy to polyetheretherketone (PEEK)
  • A history of any autoimmune disease, such as, systemic lupus erythematosus, Addison's disease, Crohn's disease, or rheumatoid arthritis
  • A history of any severe allergy or anaphylaxis, or a history of hypersensitivity to protein pharmaceuticals, or have had any previous exposure to a protein pharmaceutical
  • Are receiving treatment (before or during surgery) with a drug (e.g., steroids, methotrexate, etc.) that interferes with bone metabolism or are being treated with a bone growth stimulator
  • A medical condition requiring radiation, chemotherapy or immunosuppression, or a medical condition requiring systemic corticosteroids
  • Are covered under workmen's compensation insurance or prisoners
  • Are transient or have been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an in-subject substance abuse program
  • Have participated in clinical studies within 3 months of enrollment
  • Have a body mass index (BMI) greater than 35
  • Use tobacco products (also includes, e.g. nicotine patch or nicotine gum), or have smoked cigarettes within 6 weeks preceding enrollment
  • Known to require additional surgery to the lumbar spinal region within the next 6 months
  • Have symptomatic multilevel degenerative disease requiring possible instrumented fusion of more than one vertebral level
  • Have previously been treated with, or exposed to, therapeutic levels of Bone Morphogenetic Proteins (BMPs), i.e., synthetic or recombinant
  • Have a documented medical history or radiographic evidence of a metabolic bone disease (e.g., osteoporosis or osteopenia) or other condition which would negatively impact the bone healing process (e.g. history of Paget's disease, osteomalacia, or other osteodystrophy) or preclude the subject from receiving pedicle screw fixation
  • Are involved in or planning to engage in litigation related to back and/or leg pain
  • Require chronic SQ or IV heparin therapies
  • Have an Osteoporosis Risk Assessment Instrument (ORAI) score > to 9 points and, if so, will require a qualifying DEXA scan T score

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): NCT00798239


Locations
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Canada, Alberta
Confidential
Calgary, Alberta, Canada, T2N 2T9
Canada, Nova Scotia
Confidential
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Confidential
Ottawa, Ontario, Canada, K1Y 4E9
Confidential
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Confidential
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
BioSurface Engineering Technologies, Inc
Investigators
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Study Director: Brent Atkinson, PhD BioSurface Engineering Technologies, Inc

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Responsible Party: BioSurface Engineering Technologies, Inc
ClinicalTrials.gov Identifier: NCT00798239     History of Changes
Other Study ID Numbers: PFX-101
First Posted: November 26, 2008    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012

Keywords provided by BioSurface Engineering Technologies, Inc:
DDD
Spondylolisthesis
Spine Fusion
Lumbar Spine
Bone Graft

Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis