Introduction and Objective: To address the broadest patient population in T1D, there is a clear need for a minimally invasive graft that can support both immune tolerance and islet function subcutaneously. We sought to determine if using a 3D bioprinting technique termed FRESH to fabricate islet scaffolds from extracellular matrix (ECM) proteins could combine the engraftment benefits of ECM-based approaches with the precision, reproducibility, and retrievability of engineered systems to facilitate islet scaffold engraftment subcutaneously. Methods: Human cadaveric islet scaffolds contained a core islet compartment (2000 IEQ/scaffold) FRESH printed from 30 mg/mL fibrin surrounded by an outer layer of 12 mg/mL collagen type I. Human islet scaffolds were implanted subcutaneously into diabetic SCID Beige mice, while control mice received an equal number of islets via subcutaneous injection. Results: Diabetic SCID Beige mice that received FRESH printed islet scaffolds subcutaneously were normoglycemic in ~3 weeks, whereas all islet injection controls remained diabetic (Fig. 1, A and B). At day 92, two mice which received scaffolds underwent IPGTT and displayed a return to normoglycemia (C) while post-IPGTT serum analysis detected human C-peptide (D). Conclusion: FRESH printing scaffolds from ECM proteins promotes the engraftment of high-density islet scaffolds in the subcutaneous space to restore normoglycemia. A. Hudson: Employee; FluidForm Bio. P. Bradley: Employee; Fluidform Bio. S. Finkel: Employee; FluidForm Bio. K.M. Russ: Employee; FluidForm Bio. F. Dogan: Employee; Fluidform Bio. H. Ennajdaoui: None. M.P. Graffeo: Employee; FluidForm Bio. A.W. Feinberg: None.
Abstract Background Foot and ankle arthrodesis procedures are frequently performed in concert with the utilization of bone grafts. However, the availability of autologous bone is often limited, inaccessible, or not suitable, thus there is a need for bone graft substitutes with equally effective clinical outcomes. A next generation integrative bone matrix (IBM) has been developed that has intrinsic osteogenic, osteoconductive, and osteoinductive characteristics, and is a promising solution to mitigate complications such as nonunion and reduce the need for autologous bone graft harvest. Methods The charts of twenty subjects undergoing foot and ankle fusion procedures with INFLUX™ SPARC, a novel IBM, were retrospectively reviewed to determine initial clinical safety and efficacy of this next generation bone graft. Endpoints included the presence of complications or surgical reintervention, fusion rates as determined by standardized radiographic films, and patient-reported outcome measures at various time points up to 24 weeks. Results No major complications or surgical reinterventions were observed in this study. Complete radiographic fusion was achieved in all subjects by 24 weeks, with a mean overall fusion time of 8.5 ± 4.8 weeks. Subjective pain, function, and quality of life outcomes showed consistent improvements throughout the follow-up period, and all subjects (100%) achieved the minimum clinically significant mean improvements for all measures by week 24. Conclusions This study supports the use of this new IBM as a promising alternative to autologous bone grafting, offering high fusion success rates, low complications, and clinically meaningful improvements in patient-reported outcomes, particularly in higher-risk patient populations. Future investigations are needed to confirm these findings in larger and longer-term studies, and to explore the broader applications of this innovative bone graft.
Background: Severe glenohumeral osteoarthritis (GHOA) with posterior glenoid erosion remains challenging to address for shoulder surgeons. Whereas anatomic total shoulder arthroplasty (TSA) has historically been the treatment of choice, reverse shoulder arthroplasty (RSA) offers an alternative option. Limited evidence exists directly comparing these 2 treatments in a similar patient population. The purpose of this study was to compare the clinical outcomes of patients with GHOA and Walch type B2 and B3 glenoid morphologies treated with TSA vs. RSA.Methods: We performed a multicenter retrospective cohort study of patients with GHOA who were treated with primary shoulder arthroplasty and had a minimum follow-up period of 2 years. Preoperative computed tomography was used to determine type B2 and B3 glenoid morphology as described by the modified Walch classification. Three-dimensional perioperative planning software was used to characterize glenoid retroversion and humeral subluxation. Patients were categorized based on type of arthroplasty (TSA or RSA) and were matched 1:1 by sex, Walch classification, and age. Patient-reported outcome measures, active range of motion, presence and severity of glenoid loosening, and complications were compared. The percentage of patients who reached previously established clinically significant thresholds of the minimal clinically important difference and substantial clinical benefit for the American Shoulder and Elbow Surgeons score was also comparatively assessed.Results: In total, 202 patients (101 per group) with GHOA and type B2 or B3 glenoids were included in the 1:1 matched analysis. The mean length of follow-up (& PLUSMN; standard deviation) was 39 & PLUSMN; 18.7 months. The cohorts were well matched, with no differences in sex, age, American Society of Anesthesiologists score, body mass index, preoperative glenoid morphology (Walch classification), glenoid retroversion, or posterior subluxation (P > .05). RSA was associated with a lower postoperative visual analog scale pain score (0.5 in RSA group vs. 1.2 in TSA group, P = .036); however, no other no other significant differences in patient-reported significant differences in patient-reported outcome measures were found. Most patients in both groups (95.0% in TSA group vs. 98.0% in RSA group, P = .436) reached the minimal clinically important difference, and 82% of TSA patients and 90% of RSA patients reached the substantial clinical benefit value (P = .292). No significant differences in the overall complication rate (P = .781) and active range of motion were found, with the exception of internal rotation (scored on a numeric scale) being worse in the RSA group (2.7 preoperatively and 5.2 postoperatively in RSA group vs. 3.9 and 6.5, respectively, in TSA group; P < .001). Baseplate loosening occurred in 2 RSA cases, and 29 TSA cases had glenoid radiolucencies (P < .001), with 3 grossly loose glenoid components.Conclusion: Primary RSA results in short-term outcomes largely comparable to those of TSA in patients with Walch type B2 or B3 glenoid morphology. Both TSA and RSA provide substantial clinical benefit to patients with significant posterior glenoid wear.Level of evidence: Level III; Retrospective Cohort Comparison; Treatment Study & COPY; 2023 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved.
Background:Patients with workers' compensation (WC) insurance claims are often shown to experience inferior patient-reported outcomes (PROs) after an orthopaedic surgical intervention compared with patients without WC claims. Purpose:To compare the postoperative PROs of patients with WC claims (WC patients) versus those without WC claims (non-WC patients) after proximal hamstring repair (PHR). Study Design:Cohort study; Level of evidence, 3. Methods:WC patients who underwent PHR between November 2011 and to September 2020 were propensity score matched at a 1:2 ratio to non-WC patients according to age, sex, and body mass index. Comorbidity data were collected as well as minimum 1-year postoperative PRO scores for the Lower Extremity Functional Scale (LEFS), the Hip Outcome Score (HOS), and the 12-Item Short From Health Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS). The type of work was characterized according to national WC insurance guidelines as light (maximum 20 lbs [9.1 kg]), medium (maximum 50 lbs [22.7 kg]), or heavy (≥50 lbs) [>/=22.7 kg]. Results:A total of 30 patients (10 WC and 20 non-WC) were included. The work type and baseline demographic characteristics of patients did not differ between groups. There were no significant between-group differences in postoperative PRO scores as measured by the LEFS (P = .488), HOS (P = .233), or SF-12 PCS (P = .521). However, the WC cohort showed inferior SF-12 MCS scores compared with the non-WC group (49.28 ± 9.97 vs 54.26 ± 9.69, respectively; P = .032). The WC status was also associated with an increased time needed for patients to return to full-duty work capacity (21 ± 9 vs 9 ± 8 weeks; P = .005). Conclusion:Our findings suggest that WC and non-WC patients who undergo PHR have comparable outcomes. Differences in SF-12 MCS scores and return to work time for full-duty capacity warrant further investigation.
