Long bone uninfected non-union: grafting techniques.

Long bone non-unions represent a serious clinical and socioeconomical problem due to the prolonged episodes, frequent sequelae, and variable treatment effectiveness. Bone grafts, classically involving the autologous iliac crest graft as the 'gold standard' bone graft, enhance bone regeneration and fracture healing incorporating osteoconductive and/or osteoinductive/osteogenic capacity to the non-union under treatment. Structural alternatives to autologous bone grafts include allografts and bone substitutes, expanding the available stock but loosing biological properties associated with cells in the graft. Biological alternatives to autologous bone grafts include bone marrow concentration from iliac crest aspiration, bone marrow aspiration from reaming of the diaphyseal medullary canal in the long bones, and isolated, expanded mesenchymal stem cells under investigation. When the combination with natural and synthetic bone substitutes allows for larger volumes of structural grafts, the enhancement of the biological regenerative properties through the incorporation of cells and their secretoma permits to foresee new bone grafting solutions and techniques.

Preventing Atrophic Long-Bone Nonunion: Retrospective Analysis at a Level I Trauma Center.

Background: Among the risk factors for nonunion are unchangeable patient factors such as the type of injury and comorbidities, and factors that can be influenced by the surgeon such as fracture treatment and the postoperative course. While there are numerous studies analyzing unchangeable factors, there is poor evidence for factors that can be affected by the physician. This raises the need to fill the existing knowledge gaps and lay the foundations for future prevention and in-depth treatment strategies. Therefore, the goal of this study was to illuminate knowledge about nonunion in general and uncover the possible reasons for their development; Methods: This was a retrospective analysis of 327 patients from 2015 to 2020 from a level I trauma center in Germany. Information about patient characteristics, comorbidities, alcohol and nicotine abuse, fracture classification, type of osteosynthesis, etc., was collected. Matched pair analysis was performed, and statistical testing performed specifically for atrophic long-bone nonunion; Results: The type of osteosynthesis significantly affected the development of nonunion, with plate osteosynthesis being a predictor for nonunion. The use of wire cerclage did not affect the development of nonunion, nor did the use of NSAIDs, smoking, alcohol, osteoporosis and BMI; Conclusion: Knowledge about predictors for nonunion and strategies to avoid them can benefit the medical care of patients, possibly preventing the development of nonunion.

E-scooter accidents-epidemiology and injury patterns: 3-year results from a level 1 trauma center in Germany.

INTRODUCTION: Since the introduction of e-scooters in Germany in 2019, they are becoming more and more popular and associated injuries have increased significantly. The aim of this study was to assess the injury patterns after e-scooter accidents. MATERIALS AND METHODS: From May 2019 to October 2022, all consecutive patients who presented at our emergency department (ED) following e-scooter accidents were included in our study and retrospectively analyzed. RESULTS: A total of 271 patients were included in our study. The mean age was 33 years. 38% of the patients were female and 62% were male. Most common injuries were traumatic brain injuries in 38% of the patients together with fractures affecting the upper limb (17%). An operative treatment was necessary in 40 patients. Most of the patients presented at night and about 30% were under the influence of alcohol. CONCLUSIONS: Our study shows one of the largest cohort of patients suffering e-scooter accidents in Europe. Compulsory helmet use, stricter alcohol controls and locking periods could contribute significantly to safety.

Micro-Structural and Biomechanical Evaluation of Bioresorbable and Conventional Bone Cements for Augmentation of the Proximal Femoral Nail.

Osteoporotic proximal femur fractures are on the rise due to demographic change. The most dominant surgical treatment option for per/subtrochanteric fractures is cephalomedullary nailing. As it has been shown to increase primary stability, cement augmentation has become increasingly popular in the treatment of osteoporotic per/subtrochanteric femur fractures. The ultimate goal is to achieve stable osteosynthesis, allowing for rapid full weight-bearing to reduce possible postoperative complications. In recent years, bioresorbable bone cements have been developed and are now mainly used to fill bone voids. The aim of this study was to evaluate the biomechanical stability as well as the micro-structural behaviour of bioresorbable bone cements compared to conventional polymethylmethacrylate (PMMA)-cements in a subtrochanteric femur fracture model. Biomechanical as well as micro-computed tomography morphology analysis revealed no significant differences in both bone cements, as they showed equal mechanical stability and tight interdigitation into the spongious bone of the femoral head. Given the positive risk/benefit ratio for bioresorbable bone cements, their utilisation should be evaluated in future clinical studies, making them a promising alternative to PMMA-bone cements.

Gluteal Muscle Fatty Atrophy: An Independent Risk Factor for Surgical Treatment in Elderly Patients Diagnosed with Type-III Fragility Fractures of the Pelvis.

BACKGROUND: Gluteal muscle fatty atrophy (gMFA) might impair pelvic stability and negatively influence remobilization in patients with fragility fractures of the pelvis (FFP). This study aimed to investigate the association between gMFA and surgical indication in patients with FFP. METHODS AND MATERIALS: A retrospective analysis of 429 patients (age ≥80) diagnosed with FFP was performed. gMFA of the gluteus maximus, medius, and minimus was evaluated using a standard scoring system based on computer tomography images. RESULTS: No significant difference was found in gMFA between genders or among FFP types. The severity of gMFA did not correlate with age. The severity of gMFA in the gluteus medius was significantly greater than in the gluteus maximus, whereas the most profound gMFA was found in the gluteus minimus. gMFA was significantly more severe in patients who underwent an operation than in conservatively treated patients with type-III FFP, and an independent correlation to surgical indication was found using logistic regression. CONCLUSION: Our findings imply that gMFA is an independent factor for surgical treatment in patients with type-III FFP. Besides focusing on the fracture pattern, the further evaluation of gMFA could be a feasible parameter for decision making toward either conservative or surgical treatment of type-III FFP.

Biomechanical stability of short versus long proximal femoral nails in osteoporotic subtrochanteric A3 reverse-oblique femoral fractures: a cadaveric study.

PURPOSE: Due to the demographic change towards an older society, osteoporosis-related proximal femur fractures are steadily increasing. Intramedullary nail osteosyntheses are available in different lengths, where the field of application overlaps. The aim of this study was to investigate whether subtrochanteric fractures can also be treated stably using a short femoral intramedullary nail in cadaveric bones. METHODS: A short PFNA and a long PFNA were implanted in both seven artificial bones and osteoporotic human specimens. A standardized AO 31-A3 (reverse-oblique) fracture was placed in the specimens with a lateral fracture spur 2 cm proximal to the distal locking screw (short PFNA) and embedded. The simulated iliotibial tract was preloaded to 50 N. The force was applied at 10 mm/min up to a force of 200-800 N (artificial bones) and 200-400 N (human specimens). The dislocation of the fracture gap, the axial bone stiffness of bone construct and the force curve of the tractus iliotibialis were measured. RESULTS: There is no difference in the use of a short versus long PFNA in terms of stiffness of the overall construct and only a slight increase in dislocation in the fracture gap results with short PFNA compared to a long intramedullary nail. CONCLUSION: In summary of the available literature, the present study supports the thesis that there is no clinical difference between long versus short nails in A3 femur fractures. Furthermore, the present study defines a safe biomechanical range of fracture extension above the locking screw of the short intramedullary nail. LEVEL OF EVIDENCE: III.

Changing patterns in the epidemiology of tibial plateau fractures: a 10-year review at a level-I trauma center.

PURPOSE: Mobility patterns of western societies have been changing due to ongoing demographic change. Therefore, continuously updated epidemiological data on fracture morphology and treatment strategies are needed. METHODS: This retrospective single-center study included all tibial plateau fractures (TPF) between January 2011 and December 2020 in a level-I trauma center in Central Europe. Epidemiology, trauma mechanism and fracture morphology were analyzed. Age- and sex-specific differences regarding fracture classification (Schatzker, AO/OTA, Moore) and changes during the study period are highlighted. RESULTS: A total of 607 patients (55.2% women, 44.8% men, mean age 52.9 years (± 17.9)) were included in the study, 462 (76.1%) thereof having undergone surgical treatment. Over the decade, an increase in mean age (+ 7.4 years; p = 0.10), incidence (+ 68%; p < 0.05) and low-energy trauma was observed, with the highest peak in elderly women. Within classifications, AO/OTA 41-B3 (24.9%), Schatzker II (26.8%) and Moore V (46.6%) fractures were the most common. CONCLUSION: Incidence (+ 68%), mean age and fractures with signs of knee dislocation of tibial plateau fracture increased over the last decade and low-energy trauma mechanism are more frequent. As the increase in incidence is mainly seen in older women, the comorbidities and need for immediate postoperative full weight-bearing have to be considered in treatment strategies.

High rate of complications after corrective midfoot/subtalar arthrodesis and Achilles tendon lengthening in Charcot arthropathy type Sanders 2 and 3.

PURPOSE: Corrective midfoot resection arthrodesis is the standard treatment of Charcot arthropathy type Sanders 2 and 3 with severe dislocation. In order to critically evaluate the effect of surgical correction, a retrospective analysis of our patient cohort was performed. Hereby, special emphasis was set on the analysis of the pre- and post-operative equinus position of the hindfoot. METHODS: Retrospectively, all patients (n = 82) after midfoot resection arthrodesis in Charcot type Sanders 2 or 3 were included. Complications were recorded, and the mean complication-free interval was calculated. Additionally, the calcaneal pitch as well as Meary's angle were measured pre- and post-operatively and in case of complications. RESULTS: Overall complication rate was 89%. Revision surgery was necessary in 46% of all patients. The mean complication-free interval was 285 days (0-1560 days). Calcaneal pitch and Meary's angle significantly improved after operation but returned to pre-operative values after onset of complications. Achilles tendon lengthening showed no significant effects on the mean complication-free interval. CONCLUSION: Operative treatment of Charcot arthropathy remains a surgical challenge with high complication rates. Surgical correction of equinus position has been highlighted for successful treatment but was not able to prevent complications in this study, which is demonstrated by the recurrent decrease of the calcaneal pitch in cases of reoperation. Therefore, as a conclusion of our results, our treatment algorithm changed towards primarily addressing the equinus malpositioning of the hindfoot by corrective arthrodesis of the hindfoot.

Biomechanical comparison of screw vs. cerclage refixation in orthogeriatric lesser trochanteric fractures: a cadaveric study.

PURPOSE: Osteoporosis-related proximal femur fractures continue to increase significantly due to demographic change. This study was designed to evaluate the biomechanical stability of two different fixation methods (cerclage vs. screw) for refixation of a trochanter minor fragment in the pertrochanteric fractures in cadaveric bones. METHODS: Artificial bones (n = 14) and human bones (n = 16) were treated with a DHS and the trochanter minor fragment was reduced by cerclage wiring or direct screw fixation. After preloading the simulated iliopsoas with 10 N, a tensile test was performed, ending with either a 70% loss of strength or avulsion of the fragment. The mean values of the avulsion force and the surface strain were recorded. RESULTS: All tensile tests showed no significant differences between refixation using a direct screw or wire cerclage, for both artificial bones and human specimens. Absolute values showed higher avulsion forces after direct screw fixation than refixation with a wire cerclage. The surface tension of specimens treated with direct screw fixation was lower than that of specimens treated with wire cerclage. An opposite effect was seen in artificial bones. Both effects were not statistically significant. CONCLUSION: Based on the equal stability after lag screw placement compared to cerclage wiring, we promote the placement of a lag screw into the lesser trochanter fragment in pertrochanteric femur fractures when using a dynamic hip screw. LEVEL OF EVIDENCE: Level III.

Intraoperative alignment correlates well with long standing radiographs - The X-ray grid method in complex knee surgery.

OBJECTIVE: While long standing radiographs (LSR) represent the gold standard for preoperative alignment assessment and planning of lower limb deformity corrections, there is no consensus about the intraoperative alignment assesments (IAC) due to various limitations of the common methods. The present study introduces a radiolucent X-ray grid with integrated radiopaque lines explicitly designed for fluoroscopic IAC and evaluates its reliability in comparsion to the LSR. METHODS: Patients with posttaumatic and congenital lower limb deformity surgery and preoperative LSR as well as fluoroscopic IAC utilizing the X-ray grid were retrospectively included to the study. The mechanical axis deviation (MAD) in percentage of the maximum tibial width from the medial to the lateral in comparison between the image pairs was set as primary outcome parameter. Multiple rater and measurements determined intra- and interobserver reliabilit of both imaging methods. In addition, the effects of age, gender, body mass index (BMI), etiology, joint line convergence angle (JLCA), and extent varus or valgus deformity were analysed. RESULTS: A total of 84 patients were finally included. The mean absolute difference of MAD between the two techniques was 7.2 ± 0.8%. MAD between the LSR and IAC correlated at a high level (R = 0.96, p <0.001). The agreement decreased with increasing extent of deformity (p <0.01) and with higher deviation of JLCA between LSR and IAC (p <0.01). Intra- and interobserver concordance correlation coefficient (CCC) for MAD measurements were 0.99 for both imaging techniques. CONCLUSION: Fluoroscopy combined with the X-ray grid method is a valid tool for intraoperative assessment of lower limb alignment in deformity correction surgery, and the correlation between LSR and IAC is better than in other similar techniques described in the literature. However, in case of severe coronal alignment deformity and highly divergent JLCA, the agreement between both imaging techniques decreases significantly.

Evidence-Based Surgical Treatment Algorithm for Unstable Syndesmotic Injuries.

BACKGROUND: Surgical treatment of unstable syndesmotic injuries is not trivial, and there are no generally accepted treatment guidelines. The most common controversies regarding surgical treatment are related to screw fixation versus dynamic fixation, the use of reduction clamps, open versus closed reduction, and the role of the posterior malleolus and of the anterior inferior tibiofibular ligament (AITFL). Our aim was to draw important conclusions from the pertinent literature concerning surgical treatment of unstable syndesmotic injuries, to transform these conclusions into surgical principles supported by the literature, and finally to fuse these principles into an evidence-based surgical treatment algorithm. METHODS: PubMed, Embase, Google Scholar, The Cochrane Database of Systematic Reviews, and the reference lists of systematic reviews of relevant studies dealing with the surgical treatment of unstable syndesmotic injuries were searched independently by two reviewers using specific terms and limits. Surgical principles supported by the literature were fused into an evidence-based surgical treatment algorithm. RESULTS: A total of 171 articles were included for further considerations. Among them, 47 articles concerned syndesmotic screw fixation and 41 flexible dynamic fixations of the syndesmosis. Twenty-five studies compared screw fixation with dynamic fixations, and seven out of these comparisons were randomized controlled trials. Nineteen articles addressed the posterior malleolus, 14 the role of the AITFL, and eight the use of reduction clamps. Anatomic reduction is crucial to prevent posttraumatic osteoarthritis. Therefore, flexible dynamic stabilization techniques should be preferred whenever possible. An unstable AITFL should be repaired and augmented, as it represents an important stabilizer of external rotation of the distal fibula. CONCLUSIONS: The current literature provides sufficient arguments for the development of an evidence-based surgical treatment algorithm for unstable syndesmotic injuries.

Peripelvic Morel-Lavallée lesion following high-energy spine trauma: Case report and review of treatment options.

The Morel-Lavallée lesion (MLL) is an internal degloving injury typically associated with high-energy trauma and is suspected to be underdiagnosed in a majority of cases. Here, we illustrate the typical clinical and radiological characteristics of an extensive peripelvic MLL in a 50-year-old patient presenting to our trauma outpatient clinic with peripelvic pain, bruising and swelling six weeks after severe spine trauma caused by a high-energy car accident. Using this case study as an example, current therapeutic approaches are discussed. Therapeutic decisions should be based on clinical symptoms, lesion size, severity, age and co-morbidities. Extensive, symptomatic and chronic lesions should be addressed with early débridement, irrigation and drainage in order to prevent complications like infection or soft tissue necrosis.

Geriatric patients with dementia show increased mortality and lack of functional recovery after hip fracture treated with hemiprosthesis.

PURPOSE: Operative timing, perioperative management and postoperative rehabilitation are rising challenges in orthopedic geriatric trauma. The aim of this study was to determine the outcome of patients with dementia or with a high number of comorbidities treated with hemiprosthesis after hip fracture. Literature regarding patients with high comorbidities is scarce, leaving nothing but endoprosthetic treatment for even the sickest, immobile patients. METHODS: A retrospective chart review of 326 patients (mean age 81 ± 9 years; 230 women and 96 men) with hip fractures treated between 2012 and 2017 with a hemiprosthesis was performed. Primary outcome measures were surgical and nonsurgical complication rates, best achievable mobilisation during the hospital stay and mortality. RESULTS: Patients with dementia had 20-fold increased risk to be bedridden after surgery and ninefold increased risk of dying (p < 0.005). Furthermore, they needed significantly more revision surgeries because of surgical complications. Patients classified ASA IV and V had significantly lower postoperative mobilization levels with only 10% able to walk with crutches and 53% bedridden. They also had significantly more non-surgical complications while dementia had no effect on non-surgical complication rate. CONCLUSION: Patients classified ASA IV and V or suffering dementia show poor outcome after hip fracture treated with hemiprosthesis. Multidisciplinary approaches including surgeons, geriatricians, physiotherapists and psychiatrists are needed to improve the outcome of these patients. Especially in a subgroup of patients, where no mobilization is expected, alternative treatment options may be considered.

Jumper's fracture of the sacrum: a novel and reproducible way for successful reduction and fixation.

PURPOSE: Surgical treatment of jumper's fractures is a highly demanding situation for the surgeon due to its rareness and frequent association with severe concomitant injuries. There is no current consensus regarding a standard treatment approach, thus reducing quality of care. Our objectives were to describe, apply and assess a novel surgical technic. METHODS: The presented research is an observational retrospective study of patients who underwent the described novel surgical intervention in a level 1 trauma center. We conducted analyses of the patient cohort using patient-related outcome measures at least 1 year after surgery, as well as investigating pain, quality of life and the clinical effectiveness of the procedure. RESULTS: A total of 24 patients (17 male and 7 female) with an average age 47 ± 16.3 years were included. ISS scores ranged from 9 to 66 with a mean ISS of 40 ± 15. Clinical scores exist of 15 out of 24 patients (62.5%). The mean VAS score was 53.7 ± 12.9. The mean EQ-5D index was 0.68 ± 0.22. Significant negative correlation existed between the ISS value and the EQ-5D index (r = - 0.704; p < 0.005) and EQ-5D VAS (r = - 0.809; p < 0.001). Anatomical reduction was achieved in all patients (n = 24). Radiological follow-up was performed in 58%. CONCLUSION: We present one of the largest studies with operatively treated jumper's fractures of the sacrum. The technique is capable of reproducibly restoring the physiological anatomy of the patient and allows pain-adapted mobilization.

Complement Factor C5a Inhibits Apoptosis of Neutrophils-A Mechanism in Polytrauma?

Life-threatening polytrauma results in early activation of the complement and apoptotic system, as well as leukocytes, ultimately leading to the clearance of damaged cells. However, little is known about interactions between the complement and apoptotic systems in PMN (polymorphonuclear neutrophils) after multiple injuries. PMN from polytrauma patients and healthy volunteers were obtained and assessed for apoptotic events along the post-traumatic time course. In vitro studies simulated complement activation by the exposure of PMN to C3a or C5a and addressed both the intrinsic and extrinsic apoptotic pathway. Specific blockade of the C5a-receptor 1 (C5aR1) on PMN was evaluated for efficacy to reverse complement-driven alterations. PMN from polytrauma patients exhibited significantly reduced apoptotic rates up to 10 days post trauma compared to healthy controls. Polytrauma-induced resistance was associated with significantly reduced Fas-ligand (FasL) and Fas-receptor (FasR) on PMN and in contrast, significantly enhanced FasL and FasR in serum. Simulation of systemic complement activation revealed for C5a, but not for C3a, a dose-dependent abrogation of PMN apoptosis in both intrinsic and extrinsic pathways. Furthermore, specific blockade of the C5aR1 reversed C5a-induced PMN resistance to apoptosis. The data suggest an important regulatory and putative mechanistic and therapeutic role of the C5a/C5aR1 interaction on PMN apoptosis after polytrauma.

Inferior Outcome after Unstable Trochanteric Fracture Patterns Compared to Stable Fractures in the Elderly.

BACKGROUND: Various risk factors affecting outcome of elderly patients after proximal femur fracture have been identified. The present study aims to evaluate the impact of the fracture pattern in trochanteric fractures on postoperative mobility and complications. METHODS: Ninety-two patients with a mean age of 84 years were included. According to the revised AO/OTA classification, fractures were divided into stable (AO 31A1) and unstable (AO 31A2/3) patterns. A follow-up examination was performed 12 months after cephalomedullary fixation to assess outcome parameters for mobility/activities of daily living (Parker Mobility Score (PMS)/Barthel Index (BI)) and complications (increase in requirement of care, hospital readmission, mortality rate). RESULTS: At follow-up, patients with unstable trochanteric fracture patterns presented with lower PMS and BI compared to stable fractures (p < 0.05). Further, higher requirement of care and higher readmission rates compared to stable patterns were observed. CONCLUSION: Unstable trochanteric fractures presented inferior outcome compared to simple fracture patterns. This might be explained by the increasing surgical trauma in unstable fractures as well as by the mechanical impact of the lesser trochanter, which provides medial femoral support and is of functional relevance. Subsequent studies should assess if treatment strategies adapted to the specific fracture pattern (refixation of lesser trochanter) influence outcome in unstable trochanteric fractures.

Hemorrhagic shock induces renal complement activation.

PURPOSE: Complement is activated in hemorrhagic shock and protective effects by specific complement inhibition were shown. However, it remains unclear if complement activation contributes to the local tissue damage and organ failure. Zonulin is known to activate complement and affect organ failure. Therefore, local and systemic complement activation during hemorrhagic shock and its consequences on zonulin were examined. METHODS: Porcine hemorrhagic shock (n = 9) was initiated with mean arterial blood pressure maintained constant for 4 h before retransfusion. Before, 4 h after hemorrhage and 12 and 22 h after resuscitation, central and renal blood samples were drawn. Analysis included HMGB-1, C3a, and zonulin (blood and kidney homogenisates) as well as terminal complement complex (TCC) and CH50 (blood). Organ samples were taken for histological and immunohistochemical analyses (C3c). RESULTS: HMGB-1 was significantly elevated in plasma 4 h after hemorrhagic shock and in homogenized kidneys. TCC after 12 h was significantly elevated centrally, while renal levels were not altered. In contrast, CH50 showed diminished renal values, while normal central levels were observed. Local complement activation was observed with enhanced C3c deposition in kidneys. Zonulin showed significantly diminished levels at 12 and 22 h after hemorrhagic shock (central and renal) and significantly correlated with levels of CH50 and neutrophil gelatinase-associated lipocalin (NGAL). CONCLUSION: The more pronounced complement activation centrally might indicate consumption of complement products in kidney tissue, which is underlined by C3c staining. Together with diminished levels of zonulin in both systemic and local samples, results could indicate the involvement of complement as well as zonulin in acute kidney failure.

Early efficacy evaluation of mesenchymal stromal cells (MSC) combined to biomaterials to treat long bone non-unions.

BACKGROUND AND STUDY AIM: Advanced therapy medicinal products (ATMP) frequently lack of clinical data on efficacy to substantiate a future clinical use. This study aims to evaluate the efficacy to heal long bone delayed unions and non-unions, as secondary objective of the EudraCT 2011-005441-13 clinical trial, through clinical and radiological bone consolidation at 3, 6 and 12 months of follow-up, with subgroup analysis of affected bone, gender, tobacco use, and time since the original fracture. PATIENTS AND METHODS: Twenty-eight patients were recruited and surgically treated with autologous bone marrow derived mesenchymal stromal cells expanded under Good Manufacturing Practices, combined to bioceramics in the surgical room before implantation. Mean age was 39 ± 13 years, 57% were males, and mean Body Mass Index 27 ± 7. Thirteen (46%) were active smokers. There were 11 femoral, 4 humeral, and 13 tibial non-unions. Initial fracture occurred at a mean ± SD of 27.9 ± 31.2 months before recruitment. Efficacy results were expressed by clinical consolidation (no or mild pain if values under 30 in VAS scale), and by radiological consolidation with a REBORNE score over 11/16 points (value of or above 0.6875). Means were statistically compared and mixed models for repeated measurements estimated the mean and confidence intervals (95%) of the REBORNE Bone Healing scale. Clinical and radiological consolidation were analyzed in the subgroups with Spearman correlation tests (adjusted by Bonferroni). RESULTS: Clinical consolidation was earlier confirmed, while radiological consolidation at 3 months was 25.0% (7/28 cases), at 6 months 67.8% (19/28 cases), and at 12 months, 92.8% (26/28 cases including the drop-out extrapolation of two failures). Bone biopsies confirmed bone formation surrounding the bioceramic granules. All locations showed similar consolidation, although this was delayed in tibial non-unions. No significant gender difference was found in 12-month consolidation (95% confidence). Higher consolidation scale values were seen in non-smoking patients at 6 (p = 0.012, t-test) and 12 months (p = 0.011, t-test). Longer time elapsed after the initial fracture did not preclude the occurrence of consolidation. CONCLUSION: Bone consolidation was efficaciously obtained with the studied expanded hBM-MSCs combined to biomaterials, by clinical and radiological evaluation, and confirmed by bone biopsies, with lower consolidation scores in smokers.

Feasibility and safety of treating non-unions in tibia, femur and humerus with autologous, expanded, bone marrow-derived mesenchymal stromal cells associated with biphasic calcium phosphate biomaterials in a multicentric, non-comparative trial.

BACKGROUND: ORTHO-1 is a European, multicentric, first in human clinical trial to prove safety and feasibility after surgical implantation of commercially available biphasic calcium phosphate bioceramic granules associated during surgery with autologous mesenchymal stromal cells expanded from bone marrow (BM-hMSC) under good manufacturing practices, in patients with long bone pseudarthrosis. METHODS: Twenty-eight patients with femur, tibia or humerus diaphyseal or metaphyso-diaphyseal non-unions were recruited and surgically treated in France, Germany, Italy and Spain with 100 or 200 million BM-hMSC/mL associated with 5-10 cc of bioceramic granules. Patients were followed up during one year. The investigational advanced therapy medicinal product (ATMP) was expanded under the same protocol in all four countries, and approved by each National Competent Authority. FINDINGS: With safety as primary end-point, no severe adverse event was reported as related to the BM-hMSC. With feasibility as secondary end-point, the participating production centres manufactured the BM-hMSC as planned. The ATMP combined to the bioceramic was surgically delivered to the non-unions, and 26/28 treated patients were found radiologically healed at one year (3 out of 4 cortices with bone bridging). INTERPRETATION: Safety and feasibility were clinically proven for surgical implantation of expanded autologous BM-hMSC with bioceramic. FUNDING: EU-FP7-HEALTH-2009, REBORNE Project (GA: 241876).

[Complications after intramedullary stabilization of clavicle fractures]. / Komplikationen nach intramedullärer Stabilisierung von Klavikulafrakturen.

BACKGROUND: Operative treatment of clavicle fractures by intramedullary nailing with titanium elastic nailing (TEN) has been established as an alternative to plate osteosynthesis for many years. The main complication after TEN osteosynthesis is nail migration. The goal of this study was evaluation of predictors for medial nail migration and comparison with plate osteosynthesis. MATERIAL AND METHODS: A retrospective analysis of electronic patient charts, surgical protocols and radiographs of all operatively treated clavicle shaft fractures between 2010-2014 (n = 141) was performed. When evaluating the patient charts and the surgical protocols special attention was paid to the fracture type, the duration of the operation, the need for an open reduction and the onset of complications as well as the duration until implant removal. Radiographs were analyzed concerning the implant location and an implant migration. RESULTS: Surgery time (39 vs. 83 min) as well as the time to implant removal (226 vs. 495 days) were significantly reduced (p = 0.00), while complication (39% vs. 21.4%) as well as reoperation rates (15% vs. 7.1%; p = 0.033) were increased in TEN compared to plate osteosynthesis. The main complication was medial nail migration. The following predictors regarding medial migration could be identified: open or closed reduction (p = 0.021), multifragmentary fractures (p = 0.049), oblique fractures (p = 0.08) and TEN thickness (33% at 2 mm, 0% at 3 mm). DISCUSSION: Advantages of TEN are a shorter surgery time as well as a shorter duration until implant removal. The TEN osteosynthesis led to a significantly increased complication rate, with nail migration representing the major reason. When predictors for medial TEN migration are considered, type B and C fractures can also be sufficiently treated by a large diameter TEN.