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

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

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.

Study Overview

• Status: Unknown
• Conditions: Degenerative Disc Disease; Spondylolisthesis
• Intervention / Treatment: Other: Iliac crest autograft; Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules; Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Confidential
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Confidential
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Confidential
    • Toronto, Ontario, Canada, M4N 3M5
      • Confidential
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Confidential

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: AMPLEX; Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules; 750 micrograms/cc BVF; Other Names: AMPLEX
Experimental: Prefix 750; Prefix (AMPLEX) B2A Enhanced Ceramic Granules	Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules; 150 micorgrams/cc BVF; Other Names: AMPLEX; Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules; 750 micrograms/cc BVF; Other Names: AMPLEX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	12 months post surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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	12 months post surgery

Collaborators and Investigators

• Sponsor: BioSurface Engineering Technologies, Inc
• Investigators: Study Director: Brent Atkinson, PhD, BioSurface Engineering Technologies, Inc

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Anticipated): May 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: November 24, 2008
• First Submitted That Met QC Criteria: November 25, 2008
• First Posted (Estimate): November 26, 2008

Study Record Updates

• Last Update Posted (Estimate): March 9, 2012
• Last Update Submitted That Met QC Criteria: March 7, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: DDD; Spondylolisthesis; Spine Fusion; Lumbar Spine; Bone Graft
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spondylolisthesis
• Other Study ID Numbers: PFX-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No