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.
The current study will collect clinical evidence for OSTEOAMP SELECT in spinal fusion procedures. In particular, the study will explore the use of OSTEOAMP SELECT as part of a lumbar interbody fusion (LIF) procedure of two lumbar motion segments between L2 to S1 in patients suffering from symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or mild degenerative scoliosis. Effectiveness will be based on the lumbar interbody fusion rate at the index levels assessed by a treatment-blinded independent reviewer at 12 months and 24 months. Safety will be evaluated by documenting the number and nature of all (serious) adverse events that may in any way be related to the surgical procedure or product. The complication rate will be compared to the rate in control populations from literature.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
OSTEOAMP SELECT Fibers (derived from human bone allograft) rehydrated with bone marrow aspirate (BMA) and combined with local autogenous graft for use in lumbar interbody fusion of the lumbar spine.
The Infuse Bone Graft/Medtronic Interbody Fusion Device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, known as dibotermin alfa) placed on an absorbable collagen sponge (ACS). rhBMP-2 is the active agent in the Infuse Bone Graft component. The ACS is a soft, white, pliable, absorbent implantable matrix for rhBMP-2.
Yale University
New Haven, Connecticut, United States
RECRUITINGKansas Joint and Spine Specialists
Wichita, Kansas, United States
RECRUITINGFusion Status
Radiographic fusion as defined by the Image Review Charter and assessed by an independent core laboratory.
Time frame: 12 Months
Fusion Status
Radiographic fusion as defined by the Image Review Charter and assessed by an independent core laboratory.
Time frame: 24 Months
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Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States
Spine Institute of Louisiana
Shreveport, Louisiana, United States
ACTIVE_NOT_RECRUITINGNew England Baptist Hospital
Boston, Massachusetts, United States
RECRUITINGTennessee Orthopaedic Alliance
Nashville, Tennessee, United States
RECRUITINGAustin Neurosurgeons
Austin, Texas, United States
RECRUITINGOrthoVirginia
Richmond, Virginia, United States
RECRUITINGWest Virginia University
Morgantown, West Virginia, United States
RECRUITING