Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)

• The proportion of subjects with radiographically apparent fusion. [ Time Frame: 6-months, 12-months and 24-months ] [ Designated as safety issue: No ]
  

• The evaluation of angular displacement on flexion/extension films. [ Time Frame: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month ] [ Designated as safety issue: No ]
  
• The evaluation of bridging bone on CT. [ Time Frame: 6-month, 12-month ] [ Designated as safety issue: No ]
  
• Preservation of interbody height over time. [ Time Frame: All post-operative follow-up visits: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month ] [ Designated as safety issue: No ]
  
• The rate of complications attributable to the use of Osteocel Plus requiring intervention. [ Time Frame: All study follow-up visits: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month ] [ Designated as safety issue: No ]
  
• The change in subject self-reported pain ratings (VAS scores). [ Time Frame: from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months) ] [ Designated as safety issue: No ]
  
• The change in Oswestry Disability Index scores. [ Time Frame: from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months) ] [ Designated as safety issue: No ]
  

Biological: biologic, Osteocel Plus
Osteocel® Plus
Other Name: Osteocel® Plus

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.