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Abstract Background The current report investigates fusion rates and patient-reported outcomes following lumbar spinal surgery using cellular bone allograft (CBA) in patients with risk factors for non-union. Methods A prospective, open label study was conducted in subjects undergoing lumbar spinal fusion with CBA (NCT 02969616) to assess fusion success rates and patient-reported outcomes in subjects with risk factors for non-union. Subjects were categorized into low-risk (≤ 1 risk factors) and high-risk (> 1 risk factors) groups. Radiographic fusion status was evaluated by an independent review of dynamic radiographs and CT scans. Patient-reported outcome measures included quality of life (EQ-5D), Oswestry Disability Index (ODI) and Visual Analog Scales (VAS) for back and leg pain. Adverse event reporting was conducted throughout 24-months of follow-up. Results A total of 274 subjects were enrolled: 140 subjects (51.1%) were categorized into the high-risk group (> 1 risk factor) and 134 subjects (48.9%) into the low-risk group (≤ 1 risk factors). The overall mean age at screening was 58.8 years (SD 12.5) with a higher distribution of females (63.1%) than males (36.9%). No statistical difference in fusion rates were observed between the low-risk (90.0%) and high-risk (93.9%) groups (p > 0.05). A statistically significant improvement in patient-reported outcomes (EQ-5D, ODI and VAS) was observed at all time points (p

Abstract Background Autologous bone grafts are the gold standard for spinal fusion; however, harvesting autologous bone can result in donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allografts (CBAs) are a viable alternative that avoids the need for bone harvesting and may increase fusion success alone or when used as an adjunct material. The present study examined the efficacy and safety of CBA when used as an adjunct graft material to lumbar arthrodesis. Methods A prospective, single-arm, multicenter clinical trial (NCT 02969616) was conducted in adult subjects (> 18 years of age) undergoing lumbar spinal fusion with CBA graft (CBA used as primary (≥ 50% by volume), with augmentation up to 50%). Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcomes were assessed with the Oswestry Disability Index (ODI), and Visual Analog Scales (VAS) score for back and leg pain. Adverse events were assessed through the 24-month follow-up period. The presented data represents an analysis of available subjects (n = 86) who completed 24 months of postoperative follow-up at the time the data was locked for analysis. Results Postoperative 24-month fusion success was achieved in 95.3% of subjects (n = 82/86) undergoing lumbar spinal surgery. Clinical outcomes showed statistically significant improvements in ODI (46.3% improvement), VAS-Back pain (75.5% improvement), and VAS-Leg pain (85.5% improvement) (p

Abstract Background Patient-reported outcomes are commonly used to assess patient symptoms. The effect of specific hip pathology on relationships between perceived and objectively measured symptoms remains unclear. The purpose of this study was to evaluate differences of function and pain in patients with FAIS and DDH, to assess the correlation between perceived and objective function, and to determine the influence of pain on measures of function. Methods This prospective cross-sectional study included 35 pre-operative patients (60% female) with femoroacetabular impingement syndrome (FAIS) and 37 pre-operative patients (92% female) with developmental dysplasia of the hip (DDH). Objectively measured function (6-min walk [6MWT], single leg hop [SLHT], Biodex sway [BST], hip abduction strength [HABST], and STAR excursion balance reach [STAR] tests), patient-reported function (UCLA Activity, Hip Outcome Score [HOS], Short Form 12 [SF-12], and Hip Disability and Osteoarthritis Outcome Score [HOOS]), and patient-reported pain (HOOS Pain, visual analogue scale (VAS), and a pain location scale) were collected during a pre-surgical clinic visit. Between-group comparisons of patient scores were performed using Wilcoxon Rank-Sum tests. Within-group correlations were analyzed using Spearman’s rank correlation coefficients. Statistical correlation strength was defined as low (r = ± 0.1–0.3), moderate (r = ± 0.3–0.5) and strong (r > ± 0.5). Results Patients with DDH reported greater pain and lower function compared to patients with FAIS. 6MWT distance was moderately-to-strongly correlated with a number of patient-reported measures of function (FAIS: r = 0.37 to 0.62, DDH: r = 0.36 to 0.55). Additionally, in patients with DDH, SLHT distance was well correlated with patient reported function (r = 0.37 to 0.60). Correlations between patient-reported pain and objectively measured function were sparse in both patient groups. In patients with FAIS, only 6MWT distance and HOOS Pain (r = -0.53) were significantly correlated. In patients with DDH, 6MWT distance was significantly correlated with VAS Average (r = -0.52) and Best (r = -0.53) pain. Conclusion Pain is greater and function is lower in patients with DDH compared to patients with FAIS. Moreover, the relationship between pain and function differs between patient groups. Understanding these differences is valuable for informing treatment decisions. We recommend these insights be incorporated within the clinical continuum of care, particularly during evaluation and selection of surgical and therapeutic interventions.