Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion

Exclusion Criteria

• •symptomatic at more than one level
• •previous fusion surgery at any lumbar level with or without instrumentation.
• •any other bone grafting product other than study product and local autograft bone. e.g. rhBMP2, (recombinant human bone morphogenetic protein 2).
• •patients requiring any other interbody fusion device other than an allograft spacer (Bigfoot™, Crossfuse® Advantage). e.g. no PEEK IBF
• •more than 50% spondylolisthesis (Myerding grade III or more)
• •lumbar scoliosis greater than 11 degrees
• •osteoporosis\* (T-score of -2.5 or lower), osteomalacia, Paget's disease or --metabolic bone disease.
• •spinal tumors
• •active arachnoiditis
• •fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
• •impaired calcium metabolism
• •active infection or surgical site infection
• •rheumatoid arthritis or other autoimmune disease that affects bone healing (at the surgeon's discretion)
• •chronic steroid use except for chronic inhalers (used steroids for one month within the last 6 months) or any medical condition that requires treatment with drugs known to interfere with bone healing
• •use of glucocorticoids \> 10 mg/day
• •systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis
• •morbid obesity defined as body mass index (BMI) \>45 or a weight more than 100 lbs. over ideal body weight
• •uncontrolled diabetes documented with an Hbg A1C \>9 or insulin dependent diabetics
• •smokers unless approved by Sponsor, including electronic cigarettes and vaporizers
• •within the past two (2) years, psychosocial disorders that would preclude accurate evaluation or has a history of substance abuse any history or active cancer
• •pregnancy, or interested in becoming pregnant while participating in the study
• •participation in another investigational study within 30 days