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

Degenerative Disc Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00798902
• Other study ID #: PFX-100
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: November 24, 2008
• Last updated: March 7, 2012
• Start date: November 2008
• Est. completion date: October 2012

Study information

• Verified date: March 2012
• Source: BioSurface Engineering Technologies, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spondylolisthesis

Intervention

Device:
• Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules
150 micrograms/cc BVF

Other:
• Iliac crest autograft
autograft

Locations

Country	Name	City	State
United States	Confidential	Durango	Colorado
United States	Confidential	Jefferson City	Missouri
United States	Confidential	Johnson City	New York
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Confidential	Tyler	Texas
United States	Confidential	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
BioSurface Engineering Technologies, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes