A Prospective, Randomized, Intra-Patient Controlled, Multi-Center Clinical Investigation Evaluating OSTEOAMP SELECT Fibers Versus Infuse Bone Graft as Autograft Substitute in Lumbar Fusion Procedures
The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar interbody fusion (LIF) by means of an intra-patient control model.
• Skeletally mature male or female patient, at least 21 years of age and no more than 80 years of age, inclusive, at the time of surgery;
• Has symptomatic degenerative disc disease (DDD) of the lumbosacral spine in two levels (L2 to S1). Lumbar DDD is defined as discogenic back pain with or without radicular symptoms confirmed by patient history and radiographic studies
• Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including instability up to and including Grade 1 spondylolisthesis at the involved level(s)
• Requires fusion (i.e., symptomatic) at 2 adjacent or non-adjacent levels from L2 to S1;
• Non-responsive to non-operative treatment (e.g., bed rest, physical therapy, medication,spinal injection, manipulation, and/or TENS) for at least 6 months;
• Willing and able to comply with the study protocol (including post-operative clinical and radiographic evaluations and required rehabilitation plan) and able to understand and sign the Informed Consent.