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

Study Overview
=================
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.

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

Conditions
-----------------
Degenerative Disc Disease, Spondylolisthesis

Intervention / Treatment
-----------------
* Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules
* Other: Iliac crest autograft
* Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>The control arm is Iliac Crest Autograft | Other: Iliac crest autograft<br>* autograft<br>|
| Experimental: Prefix 150<br>Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules | Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules<br>* 150 micorgrams/cc BVF<br>* Other names: AMPLEX;|
| Experimental: Prefix 750<br>Prefix (AMPLEX) B2A Enhanced Ceramic Granules | Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules<br>* 750 micrograms/cc BVF<br>* Other names: AMPLEX;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DDD, Spondylolisthesis, Spine Fusion, Lumbar Spine, Bone Graft