Lumbar spine fusion outcomes using a cellular bone allograft with lineage-committed bone-forming cells in 96 patients

Abstract

Background Instrumented posterior lumbar fusion (IPLF) with and without transforaminal interbody fusion (TLIF) is a common treatment for low back pain when conservative interventions have failed. Certain patient comorbidities and lifestyle risk factors, such as obesity and smoking, are known to negatively affect these procedures. An advanced cellular bone allograft (CBA) with viable osteogenic cells (V-CBA) has demonstrated high fusion rates, but the rates for patients with severe and/or multiple comorbidities remain understudied. The purpose of this study was to assess fusion outcomes in patients undergoing IPLF/TLIF using V-CBA with baseline comorbidities and lifestyle risk factors known to negatively affect bone fusion. Methods This was a retrospective study of de-identified data from consecutive patients at an academic medical center who underwent IPLF procedures with or without TLIF, and with V-CBA. Baseline patient and procedure characteristics were assessed. Radiological outcomes included fusion rates per the Lenke scale. Patient-reported clinical outcomes were evaluated via the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) for back and leg pain. Operating room (OR) times and intraoperative blood loss rates were also assessed. Results Data from 96 patients were assessed with a total of 222 levels treated overall (mean: 2.3 levels) and a median follow-up time of 16 months (range: 6 to 45 months). Successful fusion (Lenke A or B) was reported for 88 of 96 patients (91.7%) overall, including in all IPLF-only patients. Of 22 patients with diabetes in the IPLF+TLIF group, fusion was reported in 20 patients (90.9%). In IPLF+TLIF patients currently using tobacco (n = 19), fusion was reported in 16 patients (84.3%), while in those with a history of tobacco use (n = 53), fusion was observed in 48 patients (90.6%). Successful fusion was reported in all 6 patients overall with previous pseudarthrosis at the same level. Mean postoperative ODI and VAS scores were significantly reduced versus preoperative ratings. Conclusion The results of this study suggest that V-CBA consistently yields successful fusion and significant decreases in patient-reported ODI and VAS, despite patient comorbidities and lifestyle risk factors that are known to negatively affect such bony healing.

Twelve-Month Results from a Prospective Clinical Study Evaluating the Efficacy and Safety of Cellular Bone Allograft in Subjects Undergoing Lumbar Spinal Fusion

“…Multilevel posterolateral fusion with ViviGen demonstrated a fusion rate of 98.7% (graded via radiographs only) [ 21 ]. A subsequent study conducted by Elgafy et al showed a fusion rate of 91.7% using ViviGen when graded by radiographs and CT [ 20 ]. Ammerman et.…”

“…Despite the widespread use of CBA in lumbar and cervical spinal fusion surgery, there is limited clinical evidence detailing associated patient outcomes [ 18 , 19 , 20 , 21 ]. The current study further investigates the safety and efficacy of CBA.…”

Characterization of an advanced viable bone allograft with preserved native bone-forming cells

“…Hall, et al (2019) reported a 98% successful fusion rate using VBA in instrumented posterior lumbar fusion (IPLF) procedures, in which 59.3% of the patients (89 of 150 patients) had undergone treatment for 4 or more levels. More recently, Elgafy, et al (2021) reported successful fusion in 91.7% of patients undergoing multilevel IPLF and who possessed multiple comorbidities and/or lifestyle risk factors. By comparison, rates of pseudarthrosis in similar procedures using varying graft materials, including autograft or DBM, are reported from 7% to as high as 48% (Cammisa Jr et al 2004;Lee et al 2009;Sengupta et al 2006).…”

Twenty-four-month interim results from a prospective clinical trial evaluating the performance and safety of a cellular bone allograft in patients undergoing lumbar spinal fusion

“…Lumbar fusion success with autologous bone graft alone have reported fusion rates of 65-93% [20][21][22][23][24] . Autologous iliac crest bone graft (ICBG) is considered the gold standard for spinal fusion 13) . However, ICBG also comes with complications, such as donor site pain, infection and prolonged recovery.…”

“…Although there is extensive use of CBAs in lumbar and cervical spinal fusion surgery, there is limited clinical literature supporting associated clinical outcomes [12][13][14][15][16] .…”