Next step trauma and orthopaedic surgery: integration of augmented reality for reduction and nail implantation of tibial fractures.

INTRODUCTION: There is a tremendous scope of hardware and software development going on in augmented reality (AR), also in trauma and orthopaedic surgery. However, there are only a few systems available for intra-operative 3D imaging and guidance, most of them rely on peri- and intra-operative X-ray imaging. Especially in complex situations such as pelvic surgery or multifragmentary multilevel fractures, intra-operative 3D imaging and implant tracking systems have proven to be of great advantage for the outcome of the surgery and can help reduce X-ray exposure, at least for the surgical team (Ochs et al. in Injury 41:1297 1305, 2010). Yet, the current systems do not provide the ability to have a dynamic live view from the perspective of the surgeon. Our study describes a prototype AR-based system for live tracking which does not rely on X-rays. MATERIALS AND METHODS: A protype live-view intra-operative guidance system using an AR head-mounted device (HMD) was developed and tested on the implantation of a medullary nail in a tibia fracture model. Software algorithms that allow live view and tracking of the implant, fracture fragments and soft tissue without the intra-operative use of X-rays were derived. RESULTS: The implantation of a medullar tibia nail is possible while only relying on AR-guidance and live view without the intra-operative use of X-rays. CONCLUSIONS: The current paper describes a feasibility study with a prototype of an intra-operative dynamic live tracking and imaging system that does not require intra-operative use of X-rays and dynamically adjust to the perspective of the surgeons due to an AR HMD. To our knowledge, the current literature does not describe any similar systems. This could be the next step in surgical imaging and education and a promising way to improve patient care.

10-year follow-up of the Columbus knee prostheses system in a prospective multicenter study.

INTRODUCTION: As endpoint of a prospective multicenter 10-year documentation using the Columbus system, this evaluation carried out results of clinical scores (Knee Society Score and Oxford Knee Score), an evaluation of radiological imaging, survival rates and a collection of complication statistics. MATERIALS AND METHODS: There was a multicenter prospective recruitment of consecutive patients with the indication for total knee replacement (TKR). Preoperatively and 10 years after implantation, clinical scores, range of motion and radiological imaging was performed. During this period, a detailed documentation of complications was made. RESULTS: A total of 210 patients were recruited in 5 centers. 140 patients were available for endpoint examination 10 years after surgery. A survival rate of 96.6% (CI 95%) for the implanted Columbus prostheses after 10 years was demonstrated. Cumulative KSS showed an improvement of 75.3 (± 38.1) points and was highly significant (p < 0.0001, t test). The average functional improvement in the Oxford score was 20.6 (± 9.5) points and was also highly significant (p < 0.0001). The ROM improved from 106.5° (± 20.5) preoperatively to 116.0° (± 11.5) (p < 0.0001, t test). There were no implant-related complications as well as no new complication documented between 5- and 10-year follow-up. CONCLUSIONS: The endpoint analysis after an observation period of 10 years provided good clinical and radiographic results. In particular, an excellent survival rate of 96.6% after 10 years was demonstrated. The data published in this study are the first to be available in a prospective multicenter study on this system, which leads to a high level of clinical significance.

Changing epidemiology of lower extremity fractures in adults over a 15-year period - a National Hospital Discharge Registry study.

BACKGROUND: Demographic changes led to an increasingly ageing population in Germany and thus to possible changes in the frequency of fractures. The primary aim of this study was to report changes in fracture rates of the lower extremities in Germany in 2002 compared to 2017 and to evaluate those changes. METHODS: Inpatient data from the German National Hospital Discharge Registry (ICD10) for 2002 and 2017 were evaluated. Changes in total counts and incidence rates were analysed for fractures in the following locations: femoral neck, pertrochanteric, subtrochanteric, distal femur, femoral shaft, proximal and distal tibia, tibial shaft, medial and lateral malleolus, and other parts of the lower leg (including bi- and trimalleolar fractures), calcaneus, talus, other tarsal bones, metatarsal bones, greater toe, lesser toe, other fractures of foot or unspecific fractures of foot and toe. Patients were classed into age groups by sex: 15-24, 25-34,35-44, 45-54, 55-64, 65-74, 75-84, 85-90 and >  90 years. RESULTS: The total count for lower extremity fractures in men and women increased slightly by 4.5% from 305,764 in 2002 to 319,422 in 2017. Hip and femur fractures increased by 23.5% from 150,565 in 2002 to 185,979 in 2017. The number of these fractures among men increased by 46% and among women by 15.3%. The total count of lower leg fractures decreased by 15.4% from 131,162 in 2002 to 110,924 in 2017. Especially, younger age groups showed a decline for all tibial segments and ankle fractures. For both sexes, the number of lower leg fractures in those 75 years or older increased in all lower leg fracture locations. Most femur and lower leg fractures occurred in women. The incidence of fractures rose sharply from 2002 to 2017, especially for older cohorts. CONCLUSION: The total numbers of lower extremity fractures increased slightly in 2017 compared to 2002 - especially hip and femur fractures among men. The incidence of almost all lower extremity fracture types among older people increased during this time. Women were particularly affected. Therefore, focused prevention programmes should be considered including an extended fracture spectrum in the elderly.

Cement augmentation of the proximal humerus internal locking system in elderly patients: a multicenter randomized controlled trial.

INTRODUCTION: Cement augmentation of the proximal humerus internal locking system (PHILOS) screws might reduce complication rates in osteoporotic bones. This study compared the risk of mechanical failure during the first year after PHILOS™ treatment of proximal humerus fractures (PHF) without (control group) and with (augmented group) screw augmentation. Secondary objectives were to report shoulder functions, quality of life (QoL), adverse events (AEs), and reoperation rates. MATERIALS AND METHODS: This multicenter randomized trial enrolled patients aged ≥ 65 years with displaced/unstable PHF from eight European centers. Randomization was performed during surgery through sealed opaque envelopes. Mechanical failures were assessed by two independent reviewers via radiographs, shoulder function by Quick DASH, SPADI, and Constant Murley scores, and QoL by EQ-5D. Follow-ups were planned at postoperative 6 weeks, 3, 6, and 12 months. RESULTS: The preliminary analysis of 6-week radiographs of the first 59 enrolled patients suggested a mechanical failure rate lower than expected and the difference between groups was too small to be detected by the planned sample size of 144. The trial was prematurely terminated after 67 patients had been enrolled: 34 (27 eligible) in the control group and 33 (29 eligible) in the augmented group. Follow-ups were performed as planned. Nine patients had mechanical failures and the failure rates (95% CI) were: augmented group, 16.1% (5.5; 33.7); control group, 14.8% (4.2; 33.7); the relative risk (95% CI) for the augmented group was 1.09 (0.32; 3.65) compared to the control group (p = 1.000). No statistically significant differences in shoulder function, QoL, and AEs were observed between study groups at 1 year. Nine patients (15.8%) underwent a revision. CONCLUSIONS: Due to premature termination, the study was underpowered. A larger study will be necessary to determine if cement augmentation lowers the risk of mechanical failure rate.

Outcome Analysis of Distal Radius Fracture with Orthosis Versus Cast Immobilization after Palmar Plate Osteosynthesis: A Randomized Controlled Study.

Although the benefits of hand orthoses were shown in previous studies, they have not been able to establish themselves in clinical routines. With a focus on patient satisfaction, this study aimed to evaluate the latest generation of hand orthoses after palmar plate osteosynthesis for isolated distal radius fractures in comparison with circular plaster casts. 50 patients (16% dropout rate) were randomly assigned to an orthotic group (immobilization by orthosis, OG) or a control group (immobilization by a plaster cast, CG). Intra-articular fractures were present in 74% of the cases, and unstable AO C3 fractures in 26%. Questionnaires on patient satisfaction, documentation of the time required, clinical scores (DASH, SF-36), range of motion, grip measurements and radiographs were used for evaluation. The OG proved to be equivalent to the plaster treatment in terms of patient satisfaction, and stability of the reduction, as well as clinical scores DASH and SF-36. The OG was even superior in terms of personal hygiene (p = 0.011), handling (p = 0.008) and better adaptability (p = 0.013). Significantly less time was required to apply the orthosis (p < 0.001). In addition to the good results achieved so far, the study showed that the latest generation of orthoses has several advantages over plaster cast therapy, and could therefore become established in everyday clinical practice.

[Failure Prevention and Management of Complications after Proximal Femoral Fractures]. / Fehlervermeidung und Komplikationsmanagement nach proximaler Femurfraktur.

BACKGROUND: Proximal femoral fractures belong to the most common fractures, especially of the elderly. There is a high load of cases and most of them have to be treated surgically. With 20% and above, the rate of complications is very high. On the one hand these are due to limited biological healing competence as well as to surgical pitfalls. METHODS: Based on the literature and our own clinical experience we want to demonstrate a standard surgical treatment of proximal femoral fractures, draw attention to the most frequent complications and provide an overview of salvage procedures. CONCLUSIONS: Because of the aging population and increasing morbidity, trauma surgery will become even more difficult. Excellent training and knowledge about the patient are becoming more important to avoid manifold complications. Once present, these complications need a detailed analysis and further diagnostics to determine which salvage procedure should be preferred. Due to the fact that there are so many different complications and procedures, evidenced based studies with large numbers cannot be found in literature.

Adverse Events in the Treatment of Periprosthetic Fractures Around the Knee - a Clinical and Radiological Outcome Analysis. / Komplikationen in der Behandlung periprothetischer Frakturen bei einliegender Knietotalendoprothese ­ eine klinisch-radiologische Outcome-Analyse.

BACKGROUND: The incidence of periprosthetic fractures associated with total knee arthroplasty (PpFxK) has been reported to be 0.3 - 5.5%. 40% of all cases are related to revision TKA. The most common localisation is the distal femur. Classification is performed according to Rorabeck (RB). RB I - II fractures are usually treated with locked plating and retrograde intramedullary nailing, whereas RB III fractures are an indication for revision arthroplasty using a hinged endoprosthesis. PpFxK of the patella can be classified according to Goldberg and PpFxK of the proximal tibia can be grouped as in Felix. Interprosthetic fractures can be regarded as a special type of PpFx. Due to the increasing numbers of TKA being performed, increasing numbers of adverse events in arthroplasty can be expected. Adverse events in the treatment of PpFxK occur in up to 41% of patients according to the literature and revision is needed in approximately 29% of all cases. Risk factors are age, osteoporosis, infection, malalignment, osteolysis/loosening of the implant and status post revision. PATIENTS: A clinical and radiographic follow-up was performed with 50 patients (14 men, 36 women) treated for PpFxK of the femur, tibia and patella between 2011 and 2015 at the department of arthroplasty at a level 1 trauma center in Europe. RESULTS: The follow-up of all patients was 68%, with an average of 19.1 ± 14.6 (1 - 49) months between PpFxK and clinical follow-up. 16% of the patients were allocated for further treatment or revision surgery from other hospitals. The patients' median age was 78.0 ± 8.8 (55 - 94) years. Most patients were affected by several orthopaedic and internal medical comorbidities. PpFxK classified as RB II were the most common fractures (60%, n = 30). PpFxK usually occurred 5.0 ± 4.8 (0 - 20) years after index TKA (primary or revision TKA), mostly in patients with CR-retaining endoprosthesis, whereas PpFxK according to Felix occurred significantly earlier and mostly in hinged TKAs. Patients achieved on average a mean Oxford Knee Score of 31.1 ± 9.9 (14 - 46) points. The functional Knee Society Score (KSS) was 52.6 ± 24.4 (20 - 100) and the mean KSS was 58.7 ± 26.8 (0 - 99) points (n = 25). Radiographic evaluation of the RB I - II patients showed frontal and sagittal malalignment in 20.6% of all cases after reduction and plate fixation. The overall rate of surgical adverse events was 50%; 44% of all RB patients needed revision surgery. Adverse events comprised non-union, failure of osteosynthesis, infection, wound healing disorders and re-fractures in the RB II and the Felix subgroup. CONCLUSION: PpFxK are severe injuries and are associated with a high rate of adverse events related to treatment. Patients often have a complex background and a history of revision surgery or periprosthetic joint infection. The treatment of PpFxK should therefore take place at a centre with expertise in traumatology as well as in revision arthroplasty. Preoperative infection diagnostic testing as well as adequate imaging (X-rays and CT) are essential. We furthermore advise early evaluation of revision arthroplasty, especially in elderly patients suffering from PpFxK with insufficient bone quality around the TKA and closeness between fracture and TKA. In the case of plate fixation, it is important to give attention to correct reduction - to prevent non-union, loosening of the implant and failure of the osteosynthesis - as well as to consider double plating.

Cement augmentation of the Proximal Femoral Nail Antirotation (PFNA) - A multicentre randomized controlled trial.

INTRODUCTION: New implant designs like the Proximal Femoral Nail Antirotation (PFNA) were developed to reduce failure rates in unstable pertrochanteric fractures in the elderly. Standardized implant augmentation with up to 6 mL of polymethylmethacrylate (PMMA) cement has been introduced to enhance implant anchorage by increasing the implant-bone interface in osteoporotic bone conditions. Biomechanically, loads to failure were significantly higher with augmentation. The primary objective of this study was to compare the mobility of patients with closed unstable trochanteric fractures treated by PFNA either with or without cement augmentation. PATIENTS AND METHODS: A prospective multicentre, randomized, patient-blinded trial was conducted with ambulatory patients aged 75 or older who sustained a closed, unstable trochanteric fracture. Surgical fixation had to be performed within 72 h after admission. Outcomes were evaluated at baseline, during surgery, 3 to 14 days after surgery, 3 months, 6 months, and 12 months after surgery. To evaluate the primary objective, patients' walking speed was assessed by the Timed Up and Go (TUG) test. Secondary objectives included the analysis of implant migration assessed on radiographs, quality of life measured by the Barthel Index, mobility measured by the Parker Mobility Score, and complications. RESULTS: Of 253 randomized patients, 223 patients were eligible: 105 patients were allocated to the PFNA Augmentation group and 118 to PFNA group. At 3 to 14 days after surgery, there was no statistical significant difference in mean walking speed between the treatment groups. For the secondary objectives, also no statistical significant differences were found. However, no patient in the PFNA Augmentation group had a reoperation due to mechanical failure or symptomatic implant migration compared to 6 patients in the PFNA group. CONCLUSIONS: Augmentation of the PFNA blade did not improve patients' walking ability compared to the use of a non-augmented PFNA but might have the potential to prevent reoperations by strengthening the osteosynthesis construct.

Therapeutic efficacy of intranasally delivered mesenchymal stem cells in a rat model of Parkinson disease.

Safe and effective cell delivery remains one of the main challenges in cell-based therapy of neurodegenerative disorders. Graft survival, sufficient enrichment of therapeutic cells in the brain, and avoidance of their distribution throughout the peripheral organs are greatly influenced by the method of delivery. Here we demonstrate for the first time noninvasive intranasal (IN) delivery of mesenchymal stem cells (MSCs) to the brains of unilaterally 6-hydroxydopamine (6-OHDA)-lesioned rats. IN application (INA) of MSCs resulted in the appearance of cells in the olfactory bulb, cortex, hippocampus, striatum, cerebellum, brainstem, and spinal cord. Out of 1 × 106 MSCs applied intranasally, 24% survived for at least 4.5 months in the brains of 6-OHDA rats as assessed by quantification of enhanced green fluorescent protein (EGFP) DNA. Quantification of proliferating cell nuclear antigen-positive EGFP-MSCs showed that 3% of applied MSCs were proliferative 4.5 months after application. INA of MSCs increased the tyrosine hydroxylase level in the lesioned ipsilateral striatum and substantia nigra, and completely eliminated the 6-OHDA-induced increase in terminal deoxynucleotidyl transferase (TdT)-mediated 2'-deoxyuridine, 5'-triphosphate (dUTP)-biotin nick end labeling (TUNEL) staining of these areas. INA of EGFP-labeled MSCs prevented any decrease in the dopamine level in the lesioned hemisphere, whereas the lesioned side of the control animals revealed significantly lower levels of dopamine 4.5 months after 6-OHDA treatment. Behavioral analyses revealed significant and substantial improvement of motor function of the Parkinsonian forepaw to up to 68% of the normal value 40-110 days after INA of 1 × 106 cells. MSC-INA decreased the concentrations of inflammatory cytokines-interleukin-1ß (IL-1ß), IL-2, -6, -12, tumor necrosis factor (TNF), interferon-γ (IFN-γ, and granulocyte-macrophage colony-stimulating factor (GM-CSF)-in the lesioned side to their levels in the intact hemisphere. IN administration provides a highly promising noninvasive alternative to the traumatic surgical procedure of transplantation and allows targeted delivery of cells to the brain with the option of chronic application.

Intranasal delivery of cells to the brain.

The safety and efficacy of cell-based therapies for neurodegenerative diseases depends on the mode of cell administration. We hypothesized that intranasally administered cells could bypass the blood-brain barrier by migrating from the nasal mucosa through the cribriform plate along the olfactory neural pathway into the brain and cerebrospinal fluid (CSF). This would minimize or eliminate the distribution of cellular grafts to peripheral organs and will help to dispense with neurosurgical cell implantation. Here we demonstrate transnasal delivery of cells to the brain following intranasal application of fluorescently labeled rat mesenchymal stem cells (MSC) or human glioma cells to naive mice and rats. After cells crossed the cribriform plate, two migration routes were identified: (1) migration into the olfactory bulb and to other parts of the brain; (2) entry into the CSF with movement along the surface of the cortex followed by entrance into the brain parenchyma. The delivery of cells was enhanced by hyaluronidase treatment applied intranasally 30 min prior to the application of cells. Intranasal delivery provides a new non-invasive method for cell delivery to the CNS.