Existing clinical evidence on the use of cellular bone matrix grafts in spinal fusion: updated systematic review of the literature

Abstract

OBJECTIVE Spinal fusion surgery is increasingly common; however, pseudarthrosis remains a common complication affecting as much as 15% of some patient populations. Currently, no clear consensus on the best bone graft materials to use exists. Recent advances have led to the development of cell-infused cellular bone matrices (CBMs), which contain living components such as mesenchymal stem cells (MSCs). Relatively few clinical outcome studies on the use of these grafts exist, although the number of such studies has increased in the last 5 years. In this study, the authors aimed to summarize and critically evaluate the existing clinical evidence on commercially available CBMs in spinal fusion and reported clinical outcomes. METHODS The authors performed a systematic search of the MEDLINE and PubMed electronic databases for peer-reviewed, English-language original articles (1970–2020) in which the articles’ authors studied the clinical outcomes of CBMs in spinal fusion. The US National Library of Medicine electronic clinical trials database (www.ClinicalTrials.gov) was also searched for relevant ongoing clinical trials. RESULTS Twelve published studies of 6 different CBM products met inclusion criteria: 5 studies of Osteocel Plus/Osteocel (n = 354 unique patients), 3 of Trinity Evolution (n = 114), 2 of ViviGen (n = 171), 1 of map3 (n = 41), and 1 of VIA Graft (n = 75). All studies reported high radiographic fusion success rates (range 87%–100%) using these CBMs. However, this literature was overwhelmingly limited to single-center, noncomparative studies. Seven studies disclosed industry funding or conflicts of interest (COIs). There are 4 known trials of ViviGen (3 trials) and Bio4 (1 trial) that are ongoing. CONCLUSIONS CBMs are a promising technology with the potential of improving outcome after spinal fusion. However, while the number of studies conducted in humans has tripled since 2014, there is still insufficient evidence in the literature to recommend for or against CBMs relative to cheaper alternative materials. Comparative, multicenter trials and outcome registries free from industry COIs are indicated.

12-Month clinical and radiographic outcomes of ViBone viable bone matrix in patients undergoing cervical and lumbar spinal fusion surgery

“…A review of initial spinal fusion clinical studies concluded that VBM grafts were safe for use in bone grafting since there were no adverse events associated with their use [ 22 ]. More recently, two systematic reviews concluded that use of VBMs for spinal fusion led to high fusion and low complication rates [ 23 , 24 ]. Specifically, 12-month fusion rates reported from using various VBMs in those studies ranged from 88–100% in cervical and 91–99% in lumbar patients, while per-level fusion ranged from 87–93% in cervical and 68–99% in lumbar segments [ 23 , 24 ].…”

“…More recently, two systematic reviews concluded that use of VBMs for spinal fusion led to high fusion and low complication rates [ 23 , 24 ]. Specifically, 12-month fusion rates reported from using various VBMs in those studies ranged from 88–100% in cervical and 91–99% in lumbar patients, while per-level fusion ranged from 87–93% in cervical and 68–99% in lumbar segments [ 23 , 24 ]. These findings align well with the results outlined in our study at 12-month evaluation for per-patient (88.1% cervical and 97.6% lumbar) and per-level fusion (98.5% cervical, 100% lumbar), with clinically meaningful improvements in pain and disability scores.…”

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

“…Musante et al reported 90% fusion success rates in patients undergoing PLF, with no significant difference in fusion rates among patients with and without risk factors to fusion [ 34 ]. In addition, Vivigen CBA (Depuy-Synthes, Raynham, MA, USA) has demonstrated high spinal fusion rates in multiple studies [ 35 ]. Multilevel posterolateral fusion with ViviGen demonstrated a fusion rate of 98.7% (graded via radiographs only) [ 21 ].…”

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

“…Vivigen (DepuySynthes, Raynham MA), have shown spinal fusion rates at 90% 27) . In a study of multilevel fusion in a posterolateral construct with CBA, the fusion rate was reported as 98.7% 15) .…”