Clinical Outcomes Following Use of a Next-Generation Cellular Bone Matrix in High-Risk Patients Undergoing...

Background Arthrodesis is a standard intervention for musculoskeletal pain, yet non-union remains a significant challenge. Systemic comorbidities such as smoking, diabetes, and obesity can lead to biological deficiencies in the signaling proteins required for bone healing at the surgical site. This study evaluates the clinical safety and efficacy of a next-generation cellular bone matrix (CBM) designed to preserve high concentrations of endogenous growth factors and viable cells that may help address potential biological deficits in at-risk populations. Methods Data were pooled from two single-center retrospective studies. The analysis included 35 high-risk participants (mean age 61.4 years with an average of 2.6 risk factors per participant) undergoing either spinal (n=18) or foot and ankle arthrodesis (n=17). Risk factors included advanced age, tobacco use, diabetes, obesity, hypertension, and revision surgery, among others. Primary efficacy was defined as radiographic fusion at standard follow-up time points. Rates of major complications and unplanned revisions were examined for safety. Results Despite these high-risk profiles, radiographic union rates were high in both cohorts. In the spine group, 100% fusion was achieved for all interbody (n=33/33) and posterolateral (n=95/95) levels by 12 months, with a median time to fusion of 6.0 months. Notably, the time to fusion was not significantly impacted by construct length in this small, exploratory subgroup comparison. In the foot and ankle cohort, 100% radiographic fusion was achieved by 24 weeks, with a median time to fusion of 6.0 weeks. There were no statistically significant differences in healing times between forefoot/midfoot and hindfoot/ankle subgroups, though these subgroups were also small and likely underpowered. Across both cohorts, the rate of non-union and graft-related adverse events was 0% (n=0). Conclusions In this small retrospective study, use of the next-generation CBM was associated with favorable fusion rates and no reported graft-related complications in a high-risk patient population. These findings are consistent with the hypothesis that a concentrated source of native growth factors and viable cells may support fusion even in biologically compromised environments. However, future powered studies, including a control group and larger patient population, are needed to confirm our preliminary findings and determine causation.