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The Masquelet technique for the treatment of large bone defects is a two‐stage procedure based on an induced membrane. The size of a scaffold is reported to be a critical factor for bone healing response. We therefore aimed to investigate the influence of the granule size of a bone graft substitute on bone marrow derived mononuclear cells (BMC) supported bone healing in combination with the induced membrane. We compared three different sizes of Herafill® granules (Heraeus Medical GmbH, Wehrheim) with or without BMC in vivo in a rat femoral critical size defect. A 10 mm defect was made in 126 rats and a membrane induced by a PMMA‐spacer. After 3 weeks, the spacer was taken out and membrane filled with different granule sizes. After 8 weeks femurs were taken for radiological, biomechanical, histological, and immunohistochemical analysis. Further, whole blood of the rat was incubated with granules and expression of 29 peptide mediators was assessed. Smallest granules showed significantly improved bone healing compared to larger granules, which however did not lead to an increased biomechanical stability in the defect zone. Small granules lead to an increased accumulation of macrophages in situ which could be assigned to the inflammatory subtype M1 by majority. Increased release of chemotactic respectively proangiogenic active factors in vitro compared to syngenic bone and beta‐TCP was observed. Granule size of the bone graft substitute Herafill® has significant impact on bone healing of a critical size defect in combination with Masquelet's technique in terms of bone formation and inflammatory.
Introduction: In patients with severe pelvic ring injuries, exsanguination still is the leading cause of death in the early post-injury phase. While mechanical pelvic ring stabilization and pre-peritoneal pelvic packing are mainly addressing venous bleeding, angio-embolization aims to control arterial bleeding. The goal of the present study was to evaluate the rate of postoperative angio-embolization after mechanical pelvic ring injury stabilization and pre-peritoneal pelvic packing. Bleeding sources detected in the angiography and the patient's outcome were investigated. Patients and Methods: Retrospective observational cohort study at a single academic level I trauma center, reviewing all patients with pelvic ring injuries admitted from 01/2010 to 12/2019. Patients with emergent mechanical pelvic ring stabilization (supraacetabular external fixator and/or pelvic C-clamp) and direct pre-peritoneal pelvic packing were further analyzed. Patients that underwent postoperative angio-embolization were compared with those that did not. All postoperative angio-embolizations were evaluated with regards to bleeding sources and type of embolization. Results: During the study period, a total of 39 patients required immediate mechanical pelvic stabilization and direct pre-peritoneal pelvic packing. Of these, 12 patients (30.8%) underwent a postoperative angio-embolization. The following vessels were identified as bleeding sources: superior gluteal artery (n = 6), obturator artery (n = 2), internal pudendal artery (n = 2), unnamed branches of the internal iliac artery (n = 3). A selective embolization was successful in 11 patients; in 1 patient, an unilateral complete occlusion of the internal iliac artery was performed to control the bleeding. Mean time from hospital admission to the surgical procedure was 52.8 ± 14.7 min and the mean time from admission to angio-embolization was 189.1 ± 55.5 min. The in-hospital mortality rate of patients with angio-embolization was 25.0% (n = 3). Of these, 2 patients died due to multiple organ failure and 1 patient due to severe head injury. Conclusion: Secondary angio-embolization after external pelvic fixation and pre-peritoneal pelvic packing was effective in controlling ongoing bleeding. The most frequently detected bleeding vessel was the superior gluteal artery, which is difficult to surgically address, further highlighting the importance of angio-embolization in the management algorithm.
BACKGROUND: Local implantation of ex vivo concentrated, washed and filtrated human bone marrow-derived mononuclear cells (BMC) seeded onto β-tricalciumphosphate (TCP) significantly enhanced bone healing in a preclinical segmental defect model. Based on these results, we evaluated in a first clinical phase-I trial safety and feasibility of augmentation with preoperatively isolated autologous BMC seeded onto β-TCP in combination with angle stable plate fixation for the therapy of proximal humeral fractures as a potential alternative to autologous bone graft from the iliac crest.
METHODS: 10 patients were enrolled to assess whether cell therapy with 1.3 × 106 autologous BMC/ml/ml β-TCP, collected on the day preceding the definitive surgery, is safe and feasible when seeded onto β-TCP in patients with a proximal humeral fracture. 5 follow-up visits for clinical and radiological controls up to 12 weeks were performed.
RESULTS: β-tricalciumphosphate fortification with BMC was feasible and safe; specifically, neither morbidity at the harvest site nor at the surgical wound site were observed. Neither local nor systemic inflammation was noted. All fractures healed within the observation time without secondary dislocation. Three adverse events were reported: one case each of abdominal wall shingles, tendon loosening and initial screw perforation, none of which presumed related to the IND.
CONCLUSIONS: Cell therapy with autologous BMC for bone regeneration appeared to be safe and feasible with no drug-related adverse reactions being described to date. The impression of efficacy was given, although the study was not powered nor controlled to detect such. A clinical trial phase-II will be forthcoming in order to formally test the clinical benefit of BMC-laden β-TCP for PHF patients. Trial registration The study was registered in the European Clinical Trial Register as EudraCT No. 2012-004037-17. Date of registration 30th of August 2012. Informed consent was signed from all patients enrolled.
Purpose: Fractures of the humerus account for 5%–8% of all fractures. Nonunion is found with an incidence of up to 15%, depending on the location of the fracture. In case of a manifest nonunion the surgeon faces a challenging problem and has to conceive a therapy based on the underlying pathology. The aim of this study was to describe our treatment concepts for this entity and present our results of the last five years.
Methods: Twenty-six patients were treated for nonunion of the humerus between January 2013 and December 2017. Their charts were reviewed retrospectively and demographic data, pathology, surgical treatment and outcome were assessed.
Results: The most frequent location for a nonunion was the humeral shaft, with the most common trauma mechanism being multiple falls. Most often atrophic nonunion (n = 14), followed by hypertrophic and infection-caused nonunion (each n = 4), were found. Our treatment concept could be applied in 19 patients, of which in 90% of those who were available for follow-up consolidation could be achieved.
Conclusion: Humeral nonunion is a heterogeneous entity that has to be analyzed precisely and be treated correspondingly. We therefore present a treatment concept based on the underlying pathology.
Purpose: The Masquelet technique for the treatment of large bone defects is a two-stage procedure based on an induced membrane. Compared to mature periosteum, the induced membrane differs significantly. However, both play a crucial role in bone regeneration. As part of a histological and radiological post-evaluation of an earlier project, we analyzed the influence of the granule size of the bone void filler Herafill® on development of periosteum regrowth in a critical size defect.
Methods: We compared three different sizes of Herafill® granules (Heraeus Medical GmbH, Wehrheim) in vivo in a rat femoral critical size defect (10 mm) treated with the induced membrane technique. After 8 weeks healing time, femurs were harvested and taken for histological and radiological analysis.
Results: A significantly increased regrowth of periosteum into the defect was found when small granules were used. Large granules showed significantly increased occurrence of bone capping. Small granules lead to significant increase in callus formation in the vicinity to the membrane.
Conclusion: The size of Herafill® granules has significant impact on the development of periosteal-like structures around the defect using Masquelet’s induced membrane technique. Small granules show significantly increased regrowth of periosteum and improved bone formation adjacent to the induced membrane.
Early vascularization is a prerequisite for successful bone healing and endothelial progenitor cells (EPC), seeded on appropriate biomaterials, can improve vascularization. The type of biomaterial influences EPC function with bioglass evoking a vascularizing response. In this study the influence of a composite biomaterial based on polylactic acid (PLA) and either 20 or 40% bioglass, BG20 and BG40, respectively, on the differentiation and survival of EPCs in vitro was investigated. Subsequently, the effect of the composite material on early vascularization in a rat calvarial critical size defect model with or without EPCs was evaluated. Human EPCs were cultured with β-TCP, PLA, BG20 or BG40, and seeding efficacy, cell viability, cell morphology and apoptosis were analysed in vitro. BG40 released the most calcium, and improved endothelial differentiation and vitality best. This effect was mimicked by adding an equivalent amount of calcium to the medium and was diminished in the presence of the calcium chelator, EGTA. To analyze the effect of BG40 and EPCs in vivo, a 6-mm diameter critical size calvarial defect was created in rats (n = 12). Controls (n = 6) received BG40 and the treatment group (n = 6) received BG40 seeded with 5×105 rat EPCs. Vascularization after 1 week was significantly improved when EPCs were seeded onto BG40, compared to implanting BG40 alone. This indicates that Ca2+ release improves EPC differentiation and is useful for enhanced early vascularization in critical size bone defects.
Treatment of large bone defects is one of the great challenges in contemporary orthopedic and traumatic surgery. Grafts are necessary to support bone healing. A well-established allograft is demineralized bone matrix (DBM) prepared from donated human bone tissue. In this study, a fibrous demineralized bone matrix (f-DBM) with a high surface-to-volume ratio has been analyzed for toxicity and immunogenicity. f-DBM was transplanted to a 5-mm, plate-stabilized, femoral critical-size-bone-defect in Sprague-Dawley (SD)-rats. Healthy animals were used as controls. After two months histology, hematological analyses, immunogenicity as well as serum biochemistry were performed. Evaluation of free radical release and hematological and biochemical analyses showed no significant differences between the control group and recipients of f-DBM. Histologically, there was no evidence of damage to liver and kidney and good bone healing was observed in the f-DBM group. Reactivity against human HLA class I and class II antigens was detected with mostly low fluorescence values both in the serum of untreated and treated animals, reflecting rather a background reaction. Taken together, these results provide evidence for no systemic toxicity and the first proof of no basic immunogenic reaction to bone allograft and no sensitization of the recipient.
Regeneration of large bone defects is a major objective in trauma surgery. Bone marrow mononuclear cell (BMC)-supported bone healing was shown to be efficient after immobilization on a scaffold. We hypothesized that fibrous demineralized bone matrix (DBM) in various forms with BMCs is superior to granular DBM. A total of 65 male SD rats were assigned to five treatment groups: syngenic cancellous bone (SCB), fibrous demineralized bone matrix (f-DBM), fibrous demineralized bone matrix densely packed (f-DBM 120%), DBM granules (GDBM) and DBM granules 5% calcium phosphate (GDBM5%Ca2+). BMCs from donor rats were combined with different scaffolds and placed into 5 mm femoral bone defects. After 8 weeks, bone mineral density (BMD), biomechanical stability and histology were assessed. Similar biomechanical properties of f-DBM and SCB defects were observed. Similar bone and cartilage formation was found in all groups, but a significantly bigger residual defect size was found in GDBM. High bone healing scores were found in f-DBM (25) and SCB (25). The application of DBM in fiber form combined with the application of BMCs shows promising results comparable to the gold standard, syngenic cancellous bone. Denser packing of fibers or higher amount of calcium phosphate has no positive effect.
Falls from a height are a common cause of polytrauma care in Level I Trauma Centers worldwide. The expected injury consequences depend on the height of the fall and the associated acceleration, as well as the condition of the ground. In addition, we further hypothesize a correlation between the cause of the fall, the age of the patient, and the patient’s outcome. A total of 178 trauma patients without age restriction who were treated in our hospital after a fall >3 m within a 5-year period were retrospectively analyzed. The primary objective was a clinically and radiologically quantifiable increase in the severity of injuries after falls from different relevant heights (>3 m, >6 m, and >9 m). The cause of the fall, either accidental or suicidal; age and duration of intensive care unit stay, including duration of ventilation; and total hospital stay were analyzed. Additionally, the frequency of urgent operations, such as, external fixation of fractures or hemi-craniectomies, laboratory parameters; and clinical outcomes were also among the secondary objectives. Sustaining a thoracic trauma or pelvis fractures increases significantly with height, and vital parameters are significantly compromised. We also found significant differences in urgent pre- and in-hospital emergency interventions, as well as organ complications and outcome parameters depending on the fall’s height.