[Influence of the general data protection regulation on data quality in registry data collection : Selection bias due to data protection requirements and the impact on key indicators for measuring the quality of care in a level 1 trauma center]. / Einfluss der Datenschutz-Grundverordnung auf die Datenqualität bei der Erhebung von Registerdaten : Selektionsbias aufgrund datenschutzrechtlicher Anforderungen und dessen Auswirkungen auf Kennzahlen zur Messung der Versorgungsqualität am Beispiel eines überregionalen Traumazentrums.

BACKGROUND: Due to the new general data protection regulations (GDPR), the requirements for correct patient information on the documentation of pseudonymized data in a registry have increased enormously. In particular, written consent applies to the TraumaRegister DGU® as it is not always possible to get written permission from severely injured patients in acute situations. Therefore, the study aimed to investigate the influence of undocumented cases due to a lack of clarification on the standardized mortality rate (SMR). MATERIAL AND METHODS: In 2019, 274 patients meeting the criteria of the baseline dataset were retrospectively recorded. In the remaining 197 patients, the RISC II score could be calculated in all cases. In addition, due to state-specific law, all deceased patients were documented in our trauma center. RESULTS: In this study with 197 primary care patients (72% male), 147 (74,6%) were informed and gave permission or died and were subsequently documented. The predicted mortality, actual mortality and SMR were 18.5%, 19.0% and 1.03, respectively. For patients who were not informed (n = 50), the predicted mortality, actual mortality, and SMR were 7.0%, 0% and 0. When these cases are included, the SMR is significantly more favorable at 0.93. CONCLUSION: Due to the lack of written consent from surviving patients, only about 75% of all patients at Leipzig University Hospital could be documented for the TraumaRegister DGU®. On the other hand, since the local legal situation permits registry documentation of deceased patients, this has a detrimental effect on the standardized mortality rate (SMR), which is about 10% higher in our collective than it actually is.

Intraoperative 3D imaging in intraarticular tibial plateau fractures - Does it help to improve the patients' outcomes?

BACKGROUND: In tibial plateau fractures (TPF) the restoration of an anatomical joint surface as well as an exact subchondral screw position for postoperative stability is crucial for the outcome. The aim of this study was to determine whether the additional use of an intraoperative 3D imaging intensifier (3D) might help to improve the outcome of complex TPF. METHODS: We performed a retrospective case-control study of a level 1 trauma center. Patients with AO/OTA 41 B3 and C-TPF operated on using a 3D imaging intensifier between November 2015 and December 2018 (3D group) were included. The outcomes of this patients were compared to patients operated without 3D imaging between January 2005 to December 2014 (2D group). The comparison of the groups was performed by matched pair analysis. The functional outcome of both groups was measured by KOOS and Lysholm Score after a follow-up period of at least 12 months. Operation time, infections and postoperative revisions were registered. RESULTS: In total, 18 patients were included in the 3D group (mean age: 51.0± 16.4 years; 12 females) and an equal number of matching partners from the 2D group (mean age: 50.3± 15.2 years; 11 females) were found (p=0.82; p=0.79). We found 9x B3, 2x C1, 1x C2, 6x C3 fractures according to AO/OTA for each group (p=1.00) with comparable ASA score (p=0.27). The mean operation time was 127.9± 45.9 min and 116.1± 45.7 min for the 3D and 2D group (p=0.28). The mean follow-up time was 20.9± 10.7 months for the 3D and 55.5± 34.7 months for the 2D group (p< 0.001). For the 3D group a mean Lysholm overall score of 67.4± 26.8 and KOOS overall score of 72.6± 23.5 could be assessed. In contrast, a mean Lysholm overall score of 62.0± 21.4 and KOOS overall score of 65.8± 21.6 could be measured in the 2D group (p=0.39; p=0.31). Thereby, functional outcome of the 3D group showed a significant higher KOOS Sport/Rec sub score of 54.7± 35.0 in comparison to the 2D group with 26.7± 31.6 (p= 0.01). Postoperative revisions had to be performed in 27.8% of cases in both groups (p=1.00). Due to the 3D imaging an intraoperative revision was performed in 33.3% (6/18). CONCLUSION: In our study we could show that re-reduction of the fracture or implant re-positioning were performed in relevant numbers based on the 3D imaging. This was associated with a midterm clinical benefit in regard to better KOOS Sport/Rec scores. TRIAL REGISTRATION: AZ 488 /20-ek.

[Challenges of primary hip arthroplasty with high hip dislocation]. / Herausforderungen der primären Hüftendoprothetik bei hoher Hüftluxation.

BACKGROUND: Endoprosthetic care of high hip dislocation is a surgical challenge. The hip anatomy is greatly altered in these patients, including a rather flat and small acetabulum with impaired bone quality and a relevant chance of a bony defect of the acetabular roof. Additionally, the front coverage and in some cases even the dorsal coverage of the hip are missing. The proximal femur is characterized with an increased antetorsion, a coxa valga position and an enlarged greater trochanter. The medullary cavity is narrowed, the offset is reduced, and the absolut leg length can be enlarged. Further anatomic variations can have been caused by previous surgeries. AIM OF THE TREATMENT: The goal of the endoprosthetic care is the re-creation of a hip with an anatomic center of rotation, an anatomic offset and equal leg length. TREATMENT: This can be achieved by a medial shift of the acetabular cup. An acetabular osteotomy including central cancellous bone graft or a bony graft to reinforce the acetabular roof might be necessary. In cases in which an anatomic acetabular cup placement is not possible, a more cranial placement can be done. Further strategies that are essential in several cases are shortening or re-orientation osteotomies of the femur, reaming of the medullary cavity and correct implant selection. Additionally, thorough soft tissue management is of main importance. Generally, the surgery should be well prepared preoperatively.

[Patella fractures in knee arthroplasty]. / Patellafrakturen in der Knieendoprothetik.

Periprosthetic patella fractures occur both with and without retropatellar joint replacement. A non-operative treatment yields satisfactory results with low morbidity. It can be applied in minimally displaced fractures that have an intact retropatellar component and an intact extensor mechanism, combined with an initial immobilization. The surgical treatment is associated with relatively poor results and with high complication rates. There was only minor improvement of functional results, no matter which surgical technique was used. Surgical intervention is still required in fractures with a loosening of the patellar component, considerable dislocations of fragments, and damage to or rupture of the extensor mechanism. In particular, type II fractures require repair of the extensor mechanism and the fracture or patellectomy. Type III fractures require a revision or resection of the patella, a patelloplasty or total patellectomy. In addition, early or late reconstruction using allograft to restore the extensor mechanism can be taken in consideration.

[Implementation of a department of plastic surgery in a university clinic for trauma surgery]. / Implementierung einer universitären Abteilung für Plastische Chirurgie in eine Klinik für Unfallchirurgie.

BACKGROUND: Since May 2012 plastic surgery for trauma patients at the University Hospital Leipzig is provided by an autonomous department. OBJECTIVES: This study analyzed the effect of plastic surgery on the changes in diagnosis-related groups (DRG) at a clinic for trauma surgery. MATERIALS AND METHODS: Within the first 2 years 37 patients (29 male and 8 female of which 38 were inpatient cases) were admitted to the clinic for trauma surgery and additionally received plastic surgery treatment. The appropriate DRG assignment as well as associated codes and revenues were recorded and compared with and without plastic surgery. RESULTS: A total of 261 operations were performed on these patients of which 71 were performed by the department of plastic surgery. The mean revenue was 22,156.44 EUR±20,578.22 EUR with a mean cost weighting of 7.2±6.7. Excluding plastic surgery treatment the mean revenue was 19,378.44 EUR±20,688.40 EUR and the mean cost weighting was 6.3±6.7. Thus, additional proceeds by the plastic surgery treatment were 2778.00 EUR±3857.01 EUR per case. The mean increase of the cost weighting was 0.9±1.3. A change of the DRG grouping occurred in 20 out of 38 cases treated. The mean length of stay (LoS) was 40.2±26.6 days. In the first year this was 17.9±22.4 days more than the mean national LoS of the appropriate DRG and 10.9±19.3 days in the second year. This means an average cost reduction of 4774.59 EUR per case. CONCLUSION: The implementation of a department for plastic surgery increased the revenues. Additional profits should be achieved by process enhancement and not by prolonged LoS.

[Interdisciplinary management of trauma patients : Update 3 years after implementation of the S3 guidelines on treatment of patients with severe and multiple injuries]. / Interdisziplinäres Traumamanagement : Update 3 Jahre nach Implementierung der S3-Leitlinie Polytrauma/Schwerverletzten-Behandlung.

BACKGROUND: The recommendations still have to be implemented 3 years after publication of the S3 guidelines on the treatment of patients with severe and multiple injuries. AIM: This article reiterates some of the essential core statements of the S3 guidelines and also gives an overview of new scientific studies. MATERIAL AND METHODS: In a selective literature search new studies on airway management, traumatic cardiac arrest, shock classification, coagulation therapy, whole-body computed tomography, air rescue and trauma centers were identified and are discussed in the light of the S3 guideline recommendations. RESULTS: The recommendations on airway management are up to date; however, recommendations on difficult airway evaluation tools, e.g. the LEMON law, should be included. The first pass success (i.e. intubation success at the first attempt) must be considered as a quality marker in the future. Video laryngoscopy is identified as a leading airway procedure in order to reach this aim. Recently estimated learning curves for endotracheal intubation and supraglottic airway devices should be implemented in qualification statements. Life-saving emergency interventions have to be performed in the prehospital setting as they do not prolong the complete treatment period for severely injured patients up to discharge from the resuscitation room. The outcome of patients suffering from traumatic cardiac arrest is better than expected. Recently developed algorithms for trauma patients have to be implemented. The prehospital trauma life support (PHTLS) and advanced trauma life support (ATLS) shock classification does not reflect the clinical reality; therefore, lactate, lactate clearance and base deficit should be used for evaluating the shock state in the resuscitation room. Concerning coagulation therapy, tranexamic acid is easy to administer, safe and effective as an antifibrinolytic therapy and should not be restricted to the most severely injured patients. Numerous studies have shown the positive effect of whole-body computed tomography on treatment time and outcome; however, clear indications for the use of whole-body computed tomography are lacking. Further investigations supported the positive effects of air rescue on the treatment outcome of trauma patients. CONCLUSION: The recommendations on interdisciplinary trauma management contained in the S3 guidelines on the treatment of patients with severe and multiple injuries should be implemented into the clinical routine. Additionally, the knowledge gained from more recent scientific studies is necessary for anesthetists and emergency physicians to be able to adequately implement the core statements of the S3 guidelines for the treatment of patients with severe and multiple injuries.

[Is distal femoral replacement an adequate therapeutic option after complex fractures of the distal femur?]. / Ist der distale Femurersatz als extremitätenerhaltendes Verfahren nach komplexen Frakturen am distalen Femur geeignet?

BACKGROUND: Modular distal femur replacements originally were developed for reconstructing a full weight-bearing and functional extremity after resection of primary bone tumours with large bony defects located in proximity to joints. The aim of this study was to examine the use of the modular distal femur replacements for complex fractures and severe post-traumatic sequelae of the distal femur in context to comparable studies. PATIENTS AND METHODS: Fourteen patients with complex fractures or post-traumatic sequelae and extensive bone defects requiring distal femur replacement were analysed retrospectively. Median age of the patients at the time of distal femoral replacement was 77 years and median follow-up interval was 27 months. Median follow-up was 27.0 (IQB 13.5-37.5) months (range 10-49 months). RESULTS: The indication for distal femur replacement was a periprosthetic fracture in three cases. Three further periprosthetic fractures were treated with a megaendoprosthesis after failure of osteosynthesis. In eight patients a megaendoprosthesis was implanted due to complications following ostheosynthesis for distal femoral fractures. Distal femoral arthroplasty was performed as a two-stage procedure in five patients with implant-associated infections. A lateral approach was used in six patients and a medial arthrotomy was conducted in eight patients. The median Knee Society score (KSS) improved significantly from 20.0 (IQB 7.5-30.0) points preoperatively to 80.0 (IQB 62.3-89.0) points at follow-up (p < 0.001). Complications requiring surgical intervention were documented in seven of 14 patients (50 %). In two patients wound-healing disorders and superficial infections necessitated surgery. In one patient a rupture of the patellar tendon was diagnosed. This patient subsequently also sustained a periprosthetic fracture. Another patient developed early aseptic loosening of the femoral component. The most common complication was a periprosthetic fracture in four patients. Three patients died for reasons not related to distal femoral replacement. CONCLUSION: Distal femoral replacement is an important option in reconstituting a full weight-bearing and functional lower extremity after complex fractures and post-traumatic sequelae with massive bone destruction. Particularly elderly patients regain ambulatory ability in the vast majority of cases. The relatively high complication rate demands very thorough preoperative planning as well as prompt allocation of extensive surgical procedures in the case of an adverse event.

[Current concepts of patient safety: rapid response system]. / Aktuelle Konzepte der Patientensicherheit : Das "Rapid-response"-System.

The "100,000 lives campaign" initiated a wide-spread implementation of rapid response teams in the United States. A standardized rapid response system (RRS) is designed to reduce the preventable mortality of hospitalized patients who frequently have progressive signs of physiological deterioration minutes to hours before cardiac arrest. The implementation and maturation of a team-based RRS has been shown to significantly reduce the incidence of "COR zero" calls and, in some studies, the in-hospital mortality rate. An alternative model to rapid response teams has been recently proposed which is based on defined clinical triggers to initiate a "rapid response escalation". This clinical triggers program overcomes the classic limitations of a team-based system, such as the overuse of resources and the fragmentation of patient care. The present review outlines the basic RRS concept with a focus on the debate related to the "perfect" patient safety system, namely the validity of a distinct rapid response teams approach versus a trigger-based escalation modality. The implementation of a standardized RRS should also be considered in German hospitals with the aim of improving patient safety and reducing preventable in-hospital mortality.

[Transgenic swine as potential organ donors? Results of the ex-vivo hemoperfusion hDAF transgenic kidney with human blood]. / Transgene Schweine als potentielle Organspender? Ergebnisse der Ex-vivo-Hämoperfusion hDAF-transgener Nieren mit Humanblut.

Kidney xenotransplantation is not yet a realistic clinical treatment modality. However, during the last decades more than 30 kidneys from other species have been transplanted into humans; some of the kidneys sustained some function up to 60 days. Recent progress in genetic engineering has raised the possibility to create large transgenic animals which express human complement regulatory proteins (CRP). Since early complement activation is believed to be the main triggering event for xenograft destruction, complement regulation by species-specific CRP should avoid hyperacute rejection in transspecies transplantation. The perfusion of hDAF-transgenic pig kidneys with human blood was not associated with the morphological signs of hyperacute rejection when compared to non-transgenic control organs. Specific immunohistology could demonstrate that the transgene was sufficient to regulate complement activation beyond C3 despite the endothelial deposition of xenoantibodies. In the future, these organs could be further optimized and ultimately tested in a clinical pilot protocol under appropriate immunosuppression.

Analysis of TAP2 and HLA-DP gene polymorphism in psoriasis.

TAP2 is a gene, located between HLA-DP and HLA-DQ, whose products form a transporter molecule involved in endogenous antigen processing. Polymorphic residues have been described in this gene. TAP2 is of particular interest because its involvement in antigen presentation makes it a candidate for a disease susceptibility gene. In psoriasis, two clinical subtypes analogous to the situation in diabetes type I with early onset and family history and type II with later onset and without family history have been described. We have previously shown that type I but not type II psoriasis is associated with the HLA-DRB1*0701/2, -DQA1*0201, -DQB1*0303 haplotype. To investigate whether this haplotype extends to include particular TAP2 and/or DP alleles, we tested the TAP2 and HLA-DP alleles of a control group (n = 199), patients with psoriasis type I (n = 66), and patients with psoriasis type II (n = 35) by hybridization with SSOs. Our data show that there is no significant correlation between TAP2 and/or HLA-DP gene polymorphism and psoriasis type I and/or type II. We conclude that disease association in type I psoriasis is associated with the extended haplotype HLA-B57, -Cw6, -DRB1*0701/2, -DQA1*0201, -DQB1*0303.

TAP2 gene polymorphism segregates with DR-DQ in DR/DP recombinant siblings.

RING 11, a second transport-associated gene (TAP2), has been recently identified in the DR-DP interval of the human class II region. Two predominant alleles, TAP2A and TAP2B, differing by 17 amino acids at the C-terminus of the ATP-binding domain are present in the Caucasoid population at frequencies of 79% and 21%, respectively. In the rat, polymorphism of the TAP genes were found to influence peptide loading of MHC class I molecules and, in humans, it was speculated that variation in peptide loading of HLA-B27 molecules might be also linked to factors altering antigen presentation presumably encoded in the HLA region. To determine whether TAP2 gene polymorphism may be relevant to peptide loading in humans, we typed 41 HLA-ABC, DR-identical pairs for TAP2A and TAP2B by PCR-SSO hybridization or direct genomic sequencing. In eight cases, GLO-different and, in six cases, DP-different recombinant siblings were included. Allele frequencies for TAP2A and TAP2B were as previously reported (74% and 26%, respectively). In all pairs, TAP2 gene polymorphism segregated with the DR-DQ type, mapping the TAP2 gene telomeric to the recombination hot spot in the DR-DP interval of the human class II region. We conclude that, in HLA-identical siblings, TAP2 gene differences are very unlikely to occur. Thus, in HLA-identical siblings, minor histocompatibility antigenic differences cannot be attributed to variant peptide loading due to TAP2 gene polymorphism.

Selection of unrelated bone marrow donors: does the current procedure warrant complete MHC class II identity?

Bone marrow transplantation from unrelated donors is being used increasingly for the treatment of patients with leukemia and several other hematologic disorders. Selection of unrelated bone marrow donors currently relies on serological HLA identity and negative mixed lymphocyte reactions between donor/recipient pairs. As serological HLA-DP typing is not feasible, we used the HLA-DPB1 oligonucleotide typing method to investigate whether the current selection procedure can guarantee complete MHC class II identity. In 40 consecutive patients, one third (62/193) serologically HLA-A, -B, -C, -DR and -DQ identical donors were found to be MLC negative with a relative response below 5%. HLA-DPB1 oligonucleotide typing of these MLC negative donors revealed that again only one third (20/62) was also identical for DP with their presumptive recipients. In the majority of pairs a disparity in graft-versus-host direction or in host-versus-graft direction of at least one allele was seen. These data indicate that in spite of the strict MLC criteria used, the current procedure did not warrant complete MHC class II identity. This implies that oligotyping for DPB1 can improve matching and should be introduced for typing of volunteers. We speculate that DP differences may contribute to the higher incidence of graft-versus-host disease or graft rejection in unrelated transplants.

The incidence of DPB1 differences between serological and mixed lymphocyte culture matched unrelated individuals: implications for selection of bone marrow donors.

Bone marrow transplantation from unrelated donors is being used increasingly for the treatment of patients with leukaemia and other disorders of lymphohaemopoiesis. Selection of histocompatible unrelated bone marrow donors currently relies on serological HLA identity and negative mixed lymphocyte cultures (MLC) between potential donor-recipient pairs. Since serological HLA-DP typing is not feasible, we used the HLA-DPB1 oligonucleotide typing method to test whether the current selection procedure can also guarantee identity for HLA-DP. In 40 consecutive patients, one-third (62/193) of the serologically HLA-A, -B, -C, -DR and -DQ identical donors were judged as MLC negative (relative response below 5%) with the presumptive recipient. HLA-DPB1 oligonucleotide typing of the MLC negative donors revealed that only one-third of these (20/62) were also identical for DP. In the majority of the pairs, we found a DPB1 disparity. A difference in the graft-versus-host direction was seen in 25/62 cases in the host-versus-graft direction in 28/62 cases and in both directions in 29/62 cases. These data indicate that, in spite of the strict MLC criteria used, the current procedure did not guarantee complete MHC class II identity. Therefore oligotyping for DPB1 can improve matching for DP and should be introduced for typing of volunteers. We suspect that DP differences may contribute to the higher incidence of graft-versus-host disease or graft rejection in unrelated donor transplants.

Selection of unrelated bone marrow donors: does the current procedure warrant complete MHC class II identity?

Bone marrow transplantation from unrelated donors is being used increasingly for the treatment of patients with leukemia and several other hematologic disorders. Selection of unrelated bone marrow donors currently relies on serological HLA identity and negative mixed lymphocyte reactions between donor/recipient pairs. As serological HLA-DP typing is not feasible, we used the HLA-DPB1 oligonucleotide typing method to investigate whether the current selection procedure can guarantee complete MHC class II identity. In 40 consecutive patients, one third (62/193) serologically HLA-A, -B, -C, -DR and -DQ identical donors were found to be MLC-negative with a relative response below 5%. HLA-DPB1 oligonucleotide typing of these MLC-negative donors revealed that again only one third (20/62) was also identical for DP with their presumptive recipients. In the majority of pairs a disparity in graft-versus-host direction or in host-versus-graft direction of at least one allele was seen. These data indicate that, in spite of the strict MLC criteria used, the current procedure did not warrant complete MHC class II identity. This implies that oligotyping for DPB1 can improve matching and should be introduced for typing of volunteers.

HLA-DPB1 oligonucleotide typing of a southwest German Caucasian population.

HLA-DP genotyping with sequence-specific oligonucleotides can detected known sequence variations in the polymorphic segments of the DPB1 second exon. Since the allelic polymorphism of the 22 published alleles is based on recombination of sequence motifs from six variable regions, DPB1 typing depends on the reactivity pattern of many different probes rather than from typing with single allele-specific probes. By computer simulation, we have previously shown that the minimal set of probes to define the 22 different alleles and most of the heterozygous combinations is 18. Here we describe HLA-DPB1 typing results and allele frequencies in a panel of 200 unrelated Caucasians from Southwest Germany. The result confirmed the power of the new HLA-DPB1 typing method, but we failed to detect three of the previously described alleles in our panel. To accommodate with the observed 19 different alleles, the sequence and hybridization conditions of 17 oligonucleotide probes are given, which are able to differentiate all except two, resolved by group-specific amplification, of the 190 possible heterozygous phenotypes.