Efficacy and safety of recombinant human bone morphogenetic protein-2 (rhBMP-2) combined with autologous bone for the treatment of long bone nonunion: A report of a prospective case series.

INTRODUCTION: Recombinant human Bone morphogenetic proteins have been used for the treatment of nonunions with promising results. We have been investigating both experimentally and clinically the efficacy of the rhBMP-2 with the macro / micro-porous hydroxyapatite carrier granules on the potency on the reconstruction of long bone defect. The purpose of this study was to prospectively evaluate the efficacy and safety of this specific rhBMP-2 with HA carrier granules mixed with autologous cancellous bone in patients with nonunion and bone defect resulted from the fracture related infection. MATERIALS AND METHODS: This was a retrospective review of a prospective cohort at a university hospital. Patients diagnosed with nonunion under the definition of the United States Food and Drug Administration with bone defect after long bone fractures were enrolled from January 2020 to February 2021. We included patients with atrophic and oligotrophic nonunion, and hypertrophic nonunion with malalignment that needed to be corrected. The other patient group was consisted of segmental bone defect resulted from FRI. The maximum amount of rhBMP-2 allowed in this clinical study was 6 mg and was added to autologous bone at a 1:1 ratio. Autologous bone was added to the mixture if the volume of mixed graft was insufficient to fill the bone defect. Patients were followed 3, 6, and 12 months post-operatively. Each visit, a radiograph was taken for assessment. Visual analog scale (VAS), questionnaire for quality of life (SF-12 physical component summary [PCS], mental component summary [MCS]), and weight-bearing status were collected for functional outcome assessment. Drug safety was assessed by examining BMP-2 antibodies. RESULTS: Of the 24 enrolled patients (mean age: 57 years), 15 (62.5 %), 2 (8.33 %), and 7 (29.17 %) presented atrophic nonunion, hypertrophic nonunion with deformity, and bone defect after fracture related infection, respectively. Thirteen patients had nonunion in the femur, 9 in the tibia, and 1 in the humerus and radius. The average amount of harvested autologous bone was 9.25 g and 4.96 mg of rhBMP-2. All 24 patients achieved union after 1-year follow up. The union rate was 95.83 % and 100 % at 6 and 12 months postoperatively, respectively. Preoperative SF-12 PCS (mean: 34.71) improved at 6 and 12 months postoperatively, respectively. Preoperative SF-12 MCS (mean: 42.89) improved 12 months postoperatively (49.13, p = 0.0338). Change of VAS was statistically significant 3 months postoperatively (p = 0.0012). No adverse effects or development of BMP-2 antibodies were observed. CONCLUSION: BMP-2 combined with autogenous bone resulted in excellent radiographical and functional outcomes in a relatively small prospective series of patients with nonunion and bone defect, without adverse effects. Further investigations are necessary to support our finding and optimize treatment strategies in nonunion patients.

Biomechanical Comparison of Fixation Methods for Posterior Wall Fractures of the Acetabulum: Conventional Reconstruction Plate vs. Spring Plate vs. Variable Angle Locking Compression Plate.

Background and Objectives: Acetabular fractures, though infrequent, present considerable challenges in treatment due to their association with high-energy trauma and poor prognoses. Posterior wall fractures, the most common type among them, typically have a more favorable prognosis compared to other types. Anatomical reduction and stable fixation of the posterior wall are crucial for optimal treatment outcomes. This study aimed to biomechanically compare three commonly used fixation methods for posterior wall fractures of the acetabulum-a conventional reconstruction plate, a spring plate, and a 2.7 mm variable angle locking compression plate (VA-LCP). Materials and Methods: The study utilized 6 fresh-frozen cadavers, yielding 12 hemipelvises free from prior trauma or surgery. Three fixation methods were compared using a simple acetabulum posterior wall fracture model. Fixation was performed by an orthopedic specialist, with prebending of plates to minimize errors. Hemipelvises were subjected to quasi-static and cyclic loading tests, measuring fracture gap, stiffness, and displacement under load. Results: It showed no significant differences in fracture gap among the three fixation methods under cyclic loading conditions simulating walking. However, the conventional reconstruction plate exhibited a greater stiffness compared to the spring and variable angle plates. Fatigue analysis revealed no significant differences among the plates, indicating a similar stability throughout cyclic loading. Despite differences in stiffness, all three fixation methods demonstrated adequate stability under loading conditions. Conclusions: While the conventional reconstruction plate demonstrated a superior stiffness, all three fixation methods provided sufficient stability under cyclic loading conditions similar to walking. This suggests that postoperative limitations are unlikely with any of the three methods, provided excessive activities are avoided. Furthermore, the variable angle plate-like the spring plate-offers an appropriate stability for fragment-specific fixation, supporting its use in surgical applications. These findings contribute to understanding the biomechanical performance of different fixation methods for acetabular fractures, facilitating improved surgical outcomes in challenging cases.

Far cortical locking constructs for fixation of distal femur fractures in an Asian population: A prospective observational study.

BACKGROUND: The stiffness of locked plates suppresses healing process, prompting the introduction of far cortical locking to address this issue. This study aimed to demonstrate the clinical efficacy of far cortical locking constructs in treating distal femoral fractures in an Asian population. METHODS: This multicenter prospective observational study was conducted at four university hospitals between February 2018 and February 2021. Demographic data, the presence of metaphyseal comminution, and surgical fixation details were recorded. Clinical outcomes, including single-leg standing, EQ-5D, and EQ-VAS scores, and radiologic outcomes, including the RUST score of each cortex, were evaluated and compared according to the presence of metaphyseal comminution. RESULTS: There were 37 patients (14 men and 23 women) with a mean age of 67.3 ± 11.8 years. Twenty-two patients had metaphyseal comminution (59%), and 15 presented simple fractures in metaphyseal areas. Four patients (13%) could stand on one leg >10s at 6 weeks, and 24 patients (92%) at 1 year. EQ-5D increased from 0.022 ± 0.388 to 0.692 ± 0.347, and the mean EQ-VAS 51.1 ± 13.1 to 74.1 ± 24.1 between discharge (n = 37) and post-operative 1 year (n = 33), respectively. RUST score presented increment for time, from 6.2 ± 1.8 at 6 week to 11.6 ± 1.1 at 1 year. Radiological healing demonstrated rapid increase from week 6 (16/28, 43%) to month 3 (27/31, 87%), with no obvious increase was observed in 6 months (23/26, 89%) or 12 months (25/28, 89%). Simple metaphyseal fractures presented significantly higher RUST scores at 6 weeks and 3 months, but there was no difference in RUST scores at 6 months or 1 year according to metaphyseal comminution. CONCLUSIONS: Plate constructs with far cortical locking screws provided safe and effective fixation for distal femoral fractures, with consistent radiological and clinical results, regardless of metaphyseal comminution.

Induced membrane technique with plate fixation has a lower complication rate than bone transport over a plate for segmental tibial defects larger than 5 cm.

INTRODUCTION: The treatment of segmental tibial bone defects remains a surgical challenge. While Bone Transport (BT) and Induced Membrane Technique (IMT) are effective strategies for regenerating bone, there are few comparative studies between them. This investigation undertakes a comparative analysis of BT and IMT for large segmental tibial defects stabilised through plate fixation. MATERIALS AND METHODS: Patients with segmental tibial defects exceeding 5 cm were prospectively enrolled from 2008 to 2021 in a single institution, with a minimum follow-up duration of two years. All patients underwent either BT or IMT with plate fixation of the tibia. Procedural success, primary union as well as bone and functional outcome scores were compared. Complications, including non-unions, joint contractures and deep infections requiring surgical intervention, were also compared. RESULTS: 41 patients were recruited in total. 28 patients underwent Bone Transport Over a Plate (BTOP), while 13 patients underwent IMT with Plate fixation (IMTP). The procedural success rate trended higher in IMTP compared to BTOP (100% vs. 85.7%). The primary union rate also trended higher in IMTP compared to BTOP (92.3% vs. 79.2%). BTOP and IMTP achieved similar rates of satisfactory bone outcome scores (78.6% vs. 84.6%) and functional outcome scores (75% vs. 76.5%). There was no statistical difference between procedural success, primary union, bone and functional outcome scores. The complication rate in BTOP was 78.6% (22 of 28), including five docking site or regenerate non-unions, eight deep infections and nine joint contractures. IMTP had a 38.5% (5 of 13) complication rate, including one non-union, two deep infections and two joint contractures. The complication rate was 2.04 times higher in BTOP compared to IMTP (p = 0.0117). CONCLUSIONS: BTOP and IMTP are both equally effective techniques for regenerating bone in large tibial bone defects. However, IMTP may be a safer procedure than BTOP, with a lower probability of requiring additional procedures to address complications.