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

This is an interventional treatment trial for Spondylosis Read More

Inclusion Criteria:

• is at least 18 - 75 years of age and skeletally mature
• must have symptomatic spondylosis, spondylolisthesis grade I or II, or degenerative disc disease (DDD) at one level from L2-S1 requiring a fusion
• must be a candidate to use an allograft spacer
• must be a candidate for bilateral pedicle screw placement
• must have completed a minimum of six weeks (+/- two to four weeks of bracing) of unsuccessful conservative, non-operative care
• must have discogenic back pain with or without leg pain DDD must be confirmed by MRI or CT scans followed by discography (if necessary)
• must score at least 40 % on the Oswestry Disability Index
• must score 4 or more on a 10 cm Visual Analog Scale for back pain or leg pain
• must be able to comply with the protocol's follow-up schedule
• must understand and sign the informed consent documenT

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