Osteocel® Plus in Posterior Lumbar Interbody Fusion (PLIF)
This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in a PLIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells attached to 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 20,000 cases worldwide.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Osteocel® Plus in Posterior Lumbar Interbody Fusion (PLIF): Evaluation of Radiographic and Patient Outcomes|
- To evaluate the fusion rates of Osteocel Plus in one or two level(s) for PLIF subjects. [ Time Frame: from pre-op to 24-month follow-up ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain). [ Time Frame: from pre-op to 24-month follow-up ] [ Designated as safety issue: Yes ]
- To evaluate and compare each outcome with respect to surgical time and blood loss. [ Time Frame: from pre-op to 24-month follow-up ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2009|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Biological: Osteocel Plus
This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive PLIF 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 PLIF 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.