Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-29 @ 11:51 PM
Study NCT ID:
NCT00948532
Status:
COMPLETED
Last Update Posted:
2025-12-24
First Post:
2009-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)
Sponsor:
NuVasive
Organization:
Study Overview
Official Title:
Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®): Evaluation of Radiographic and Patient Outcomes
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective, non-randomized multi-center study to compare the use of Osteocel® Plus in subjects who receive XLIF® (eXtreme Lateral Interbody Fusion) 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 XLIF 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 Bone Morphogenetic Protein (BMP).
Detailed Description:
Osteocel Plus is an allograft cellular bone matrix containing native mesenchymal stem cells (MSCs) which is intended to mimic the biologic performance of autograft without the morbidity associated with the autograft harvest. Mesenchymal stem cells, like those found in Osteocel Plus, are naturally occurring in the body and can differentiate into a variety of tissue types, depending on the local environment. Once implanted, MSCs can differentiate into osteoblasts, which produce new bone matrix. MSCs also naturally secrete bone-inducing growth factors that signal the patient's endogenous cells to migrate and participate in the bone formation process. Osteocel Plus is different from other orthobiologic products such as DBM and allograft cancellous bone because it contains living stem cells, which provide osteogenic potential. The cells include mesenchymal stem cells from an adult human donor; they are not from an embryonic source.
This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel in an XLIF 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 study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel in an XLIF 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: