This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in an ALIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells in conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately 15,000 cases worldwide.
This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive ALIF surgery at one or two levels. These subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus during their ALIF operation. Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion. This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and BMP.
Study Type
OBSERVATIONAL
Enrollment
51
biologic
University of California at San Francisco
San Francisco, California, United States
OrthoIndy, Indiana Orthopedic Hospital
Indianapolis, Indiana, United States
Indiana Spine Group, St. Joseph's Hospital
Kokomo, Indiana, United States
Twin Cities Orthopaedics, University of Minnesota Medical Center
Edina, Minnesota, United States
To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ALIF subjects.
Time frame: from pre-op to 24-months follow-up
To evaluate the rate of complications for Osteocel Plus and compare to published and/or retrospective data for autograft or bone morphogenetic protein (BMP).
Time frame: from pre-op to 24-month follow-up
To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain).
Time frame: from pre-op to 24-months post-op
To evaluate and compare each outcome with respect to surgical time and blood loss.
Time frame: pre-op to 24-month follow-up
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Ortho Montana
Billings, Montana, United States
Cleveland Clinic
Cleveland, Ohio, United States
Central Texas Spine Institute, Northwest Hills Surgical Hospital
Austin, Texas, United States