High Fusion Rates Using Trinity Elite Cellular Bone Allograft in High-Risk Patients

Introduction: Solid fusion is critical for successful spine and foot and ankle arthrodesis. Risk factors including smoking, obesity, diabetes, osteoporosis, and multilevel surgery elevate the risk of non-union. Cellular bone allografts (CBAs) have emerged as alternatives to autograft, but outcomes in high-risk populations remain insufficiently characterized. Methods: This review examines a cellular bone allograft (TE-CBA) in spine and foot and ankle fusion procedures, with a particular emphasis on outcomes in patients with risk factors for non-union. Clinical endpoints included fusion success, patient-reported outcomes, complication rates, and the influence of patient risk profiles. Only studies that included high-risk populations were analyzed. The included studies were primarily Level IV evidence (prospective/retrospective with comparisons to previously published outcomes). Results: In the lumbar spine, TE-CBA achieved a 90.5% fusion rate at 12 months and 95.3% at 24 months, with significant improvements in pain and function, even among high-risk patients. In ACDF procedures up to four levels, TE-CBA achieved a 97.4% fusion rate at 12 months, including 100% in one-, two-, and four-level procedures. In foot and ankle arthrodesis, 95.5% of patients achieved fusion within 12 months, with an average time to union of 6 months across patients with major risk factors. Studies employed strict fusion criteria, including combined motion analysis and CT-confirmed bridging bone. Conclusion: TE-CBA demonstrated consistently high fusion success across anatomical sites in cohorts that included patients at high risk for non-union. Further controlled trials and mechanistic studies are needed to elucidate how CBAs might mitigate biologically impaired bone healing environments.