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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by BioSurface Engineering Technologies, Inc.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
BioSurface Engineering Technologies, Inc
ClinicalTrials.gov Identifier:
NCT00798902
First received: November 24, 2008
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by BioSurface Engineering Technologies, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 22
Study Start Date: November 2008
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
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 micrograms/cc BVF
Other Name: AMPLEX

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798902

Locations
United States, Colorado
Confidential
Durango, Colorado, United States, 81301
United States, District of Columbia
Confidential
Washington, District of Columbia, United States, 20037
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Confidential
Jefferson City, Missouri, United States, 65101
United States, New York
Confidential
Johnson City, New York, United States, 13790
United States, Texas
Confidential
Tyler, Texas, United States, 75701
Sponsors and Collaborators
BioSurface Engineering Technologies, Inc
Investigators
Study Director: David M Hooper, PhD BioSurface Engineering Technologies, Inc
  More Information

No publications provided

Responsible Party: BioSurface Engineering Technologies, Inc
ClinicalTrials.gov Identifier: NCT00798902     History of Changes
Other Study ID Numbers: PFX-100
Study First Received: November 24, 2008
Last Updated: March 7, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 29, 2014