Twelve-Month Results from a Prospective Clinical Study Evaluating the Efficacy and Safety of Cellular Bone Allograft in Subjects Undergoing Lumbar Spinal Fusion
Abstract:Background: While autologous bone grafts remain the gold standard for spinal fusion procedures, harvesting autologous bone is associated with significant complications, including donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allograft (CBA) presents an alternative to autologous bone harvesting, with a favorable efficacy and safety profile. The current study further investigates CBA as an adjunct to lumbar spinal fusion procedures. Methods: A prospective, multicent… Show more
“…Seven studies evaluated the cervical spine, 17-19,21,22,24,27 and eleven evaluated outcomes of the lumbar spine. 14-16,20,23,25,26,28-31 One study did not longitudinally follow patients but provided a case series of patients presenting with complications of a specific lot of FiberCel cellular bone matrix. 9 Figure 1.PRISMA Flowchart.…”
Study Design Systematic Review. Objective To review the literature for complications and outcomes after the implantation of cellular bone matrix (CBM) during spine fusion. Methods The PubMed database was queried from inception to January 31, 2023 for any articles that discussed the role of and identified a specific CBM in spinal fusion procedures. Adverse events, reoperations, methods, and fusion rates were collected from all studies and reported. Results Six hundred articles were identified, of which 19 were included that reported outcomes of 7 different CBM products. Seven studies evaluated lumbar fusion, 11 evaluated cervical fusion, and 1 study reported adverse events of a single CBM product. Only 4 studies were comparative studies while others were limited to case series. Fusion rates ranged from 68% to 98.7% in the lumbar spine and 87% to 100% in the cervical spine, although criteria for radiographic fusion was variable. While 7 studies reported no adverse events, there was no strict consensus on what constituted a complication. One study reported catastrophic disseminated tuberculosis from donor contaminated CBM. The authors of 14 studies had conflicts of interest with either the manufacturer or distributor for their analyzed CBM. Conclusions Current evidence regarding the use of cellular bone matrix as an osteobiologic during spine surgery is weak and limited to low-grade non-comparative studies subject to industry funding. While reported fusion rates are high, the risk of severe complications should not be overlooked. Further large clinical trials are required to elucidate whether the CBMs offer any benefits that outweigh the risks.
“…Seven studies evaluated the cervical spine, 17-19,21,22,24,27 and eleven evaluated outcomes of the lumbar spine. 14-16,20,23,25,26,28-31 One study did not longitudinally follow patients but provided a case series of patients presenting with complications of a specific lot of FiberCel cellular bone matrix. 9 Figure 1.PRISMA Flowchart.…”
Study Design Systematic Review. Objective To review the literature for complications and outcomes after the implantation of cellular bone matrix (CBM) during spine fusion. Methods The PubMed database was queried from inception to January 31, 2023 for any articles that discussed the role of and identified a specific CBM in spinal fusion procedures. Adverse events, reoperations, methods, and fusion rates were collected from all studies and reported. Results Six hundred articles were identified, of which 19 were included that reported outcomes of 7 different CBM products. Seven studies evaluated lumbar fusion, 11 evaluated cervical fusion, and 1 study reported adverse events of a single CBM product. Only 4 studies were comparative studies while others were limited to case series. Fusion rates ranged from 68% to 98.7% in the lumbar spine and 87% to 100% in the cervical spine, although criteria for radiographic fusion was variable. While 7 studies reported no adverse events, there was no strict consensus on what constituted a complication. One study reported catastrophic disseminated tuberculosis from donor contaminated CBM. The authors of 14 studies had conflicts of interest with either the manufacturer or distributor for their analyzed CBM. Conclusions Current evidence regarding the use of cellular bone matrix as an osteobiologic during spine surgery is weak and limited to low-grade non-comparative studies subject to industry funding. While reported fusion rates are high, the risk of severe complications should not be overlooked. Further large clinical trials are required to elucidate whether the CBMs offer any benefits that outweigh the risks.
“…When comparing our fusion rates with published literature, our fusion rates are similar. Wind et al 14 reported a series of 201 patients undergoing lumbar spinal fusion through various surgical approaches with Trinity Elite, with an overall fusion rate of 90.5% as assessed radiographically by review of dynamic radiographs and CT scans. Of this sample, only 13 patients were treated with posterolateral lumbar fusion, in which they reported a fusion rate of 92.3%; the remainder of the patients relied on interbody fusion rather than posterolateral fusion.…”
Section: Discussionmentioning
confidence: 99%
“…Trinity Elite, developed by Orthofix Medical Inc, is one such cellular-based autograft (CBA) consisting of viable cancellous bone with demineralized cortical bone and osteogenic cells. Trinity in patients undergoing foot and ankle arthrodesis with comorbidities provide comparable or greater fusion rates than autograft, 7 , 8 and both animal model 6 , 9 and limited clinical studies have shown that it can be safely used for fusions involving the cervical 10 , 11 and lumbar 12 13 14 spine. However, limited evidence exists directly comparing fusion rates with Trinity with other bone graft alternatives.…”
Introduction:
Cellular-based autograft (CBA) is being used in posterolateral lumbar arthrodesis as a fusion supplementation alternative.
Objective:
To assess radiographic fusion in patients undergoing posterolateral lumbar fusion with unilateral Trinity CBA compared with contralateral local bone autograft as an internal control.
Methods:
A single surgeon's practice database was interrogated for consecutive patients undergoing primary posterolateral lumbar fusion with Trinity from 2018 to 2021. Patients had Trinity applied unilaterally, with local bone autograft applied contralaterally. Fusion was assessed postoperatively by using CT after 9 months. Demographics and patient-reported outcome measures were collected preoperatively and up to 12 months postoperatively.
Results:
Thirty-nine patients were included. There were 81 attempted fusion levels. Overall fusion rate, defined as bony bridging on at least one side of a given level for all levels fused, was 85.2% of patients. No statistically significant difference was observed in fusion rates between CBA versus local bone (79.0% versus 76.54% of levels attempted, respectively, P = 0.3527). Oswestry Disability Index improved by 3 months (P = 0.0152) and was maintained. Two patients required revision for symptomatic nonunion.
Conclusions:
Similar radiographic fusion rates were achieved with Trinity and local bone. Trinity is a viable alternative to local bone in posterolateral lumbar fusion.
“…[13][14][15] Collectively, these features provide all the grafting elements necessary for a successful bone/joint fusion. 16 Studies have shown the clinical advantage of CBAs in lumbar and cervical surgical procedures while eliminating the risk associated with autograft harvesting. 16,17 However, there is currently limited information on the efficacy and safety of CBA with foot/ankle arthrodesis, especially in pa-tients with risk for non-union.…”
Section: Introductionmentioning
confidence: 99%
“…16 Studies have shown the clinical advantage of CBAs in lumbar and cervical surgical procedures while eliminating the risk associated with autograft harvesting. 16,17 However, there is currently limited information on the efficacy and safety of CBA with foot/ankle arthrodesis, especially in pa-tients with risk for non-union. This study aims to evaluate the rate of fusion and complications in patients who underwent foot/ankle arthrodesis procedures using a CBA.…”
Morbidity associated with autograft harvest has led to the need for alternative bone grafts during fusion surgical procedures. The purpose of this study is to evaluate the efficacy of a cellular bone allograft (CBA) in patients who underwent foot/ankle fusion surgery. Retrospective data of patients who underwent foot/ankle arthrodesis using a CBA between XXXX and XXXX were collected from a single site. Patients were at least 18 years of age at the time of surgery and had ankle/foot surgery with Trinity ELITE CBA as the primary or only bone graft. Patients’ radiographic union was assessed at three (3) months, six (6) months, nine (9) months, and twelve (12) months. Twenty-two (22) patients and 29 joints were evaluated. The mean age and BMI of the cohort were 54±9yrs and 30.5±6kg/m2, respectively. The surgical indications were degenerative joint diseases, trauma, and arthritis. All patients except one had at least one risk factor for non-union. At 12 months, 21 of the 22 patients (95%) attained successful fusion with an average time of 6 months. In addition, there was a 100% fusion among patients with prior failed fusion, nicotine use, diabetes, neuropathy, and osteoporosis. There was no significant difference in time to fusion between patients with non-union risk factor(s) ≤ 1 and ≥ 2 (p=0.71). No complication or adverse event was reported following the surgery. The use of CBA resulted in high fusion among patients with the risk of non-union. CBA is a viable bone graft substitute for autograft in foot/ankle arthrodesis procedures.
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