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

BioSurface Engineering Technologies

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Degenerative Disc Disease

Spondylolisthesis

Treatments

Other: Iliac crest autograft

Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules

Study type

Interventional

Funder types

Industry

Identifiers

NCT00798902

PFX-100

Details and patient eligibility

About

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.

Enrollment

22 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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