Does Age Influence the Outcome of Lower Limb Non-Union Treatment? A Matched Pair Analysis.

BACKGROUND: Fractures in elderly patients are common and have severe implications on a socioeconomic level, as musculoskeletal integrity and competence is crucial for independence. Changes in both composition and biology of bones during aging potentially affect fracture healing adversely. The current study sought to determine the influence of age on the outcome of non-union therapy of atrophic and hypertrophic non-unions based on the "diamond concept", as well as to evaluate the well-known risk factors impairing bone healing. PATIENTS AND METHODS: All medical records, operative notes, lab data, and radiological imaging of patients that received surgical treatment of both atrophic and hypertrophic non-unions of the femur or tibia between 1 January 2010 and 31 December 2016 were thoroughly reviewed and analyzed. Patients who participated in our standardized follow-up for at least 12 months were included into a database. Patients older than 60 years were matched with patients younger than 60 based on five established criteria. The study was approved by the local ethics committee (S-262/2017). According to our inclusion criteria, a total of 76 patients older than 60 years were eligible for analysis. Via matching, two groups were formed: study group (SG; >60 years; n = 45) and control group (CG; <60 years; n = 45). RESULTS: Twelve months subsequent to treatment, the consolidation rate was equivalent in both groups (SG: 71% vs. CG: 67%). The consolidation for all patients before matching was 73%. The clinical results for the complete collective were no pain or pain with high or medium strain for 62.5%, whereas 29.6% had pain with low strain or constant pain. 7.87% had no pain levels given. Logistic regression modeling showed no influence of age >60 years on radiological or clinical outcome, whereas a significant negative correlation was revealed between patients aged 40-49 years and radiological non-union consolidation (b = -1.145 and p = 0.048). In addition, diabetes had a negative influence on non-union therapy (b = -1.145 and p = 0.048). As expected, the clinical outcome correlated significantly with the radiological outcome (p < 0.001). CONCLUSION: Surgeons should optimize both modifiable risk factors such as diabetes mellitus, as well as surgical treatment in order to achieve the best possible outcome in elderly patients. Elderly patients benefit from osseous consolidation by enabling and maintaining musculoskeletal competence due to the close correlation between clinical and radiological outcome. Advanced age alone does not negatively influence the outcome of non-union therapy and should, therefore, not be considered a risk factor. In contrast, patients in their fifth decade suffering from lower limb non-unions should be considered as high-risk patients and treatment should be modified accordingly.

Correction to: Development and validation of an objective assessment scale for chest tube insertion under 'direct' and 'indirect' rating.

Following publication of the original article [1], the author reported that the given name and family name of all authors were swapped.

Development and validation of an objective assessment scale for chest tube insertion under 'direct' and 'indirect' rating.

BACKGROUND: There is an increasing need for objective and validated educational concepts. This holds especially true for surgical procedures like chest tube insertion (CTI). Thus, we developed an instrument for objectification of learning successes: the assessment scale based on Objective Structured Assessment of Technical Skill (OSATS) for chest tube insertion, which is evaluated in this study. Primary endpoint was the evaluation of intermethod reliability (IM). Secondary endpoints are 'indirect' interrater reliability (IR) and construct validity of the scale (CV). METHODS: Every participant (N = 59) performed a CTI on a porcine thorax. Participants received three ratings (one 'direct' on site, two 'indirect' via video rating). IM compares 'direct' with 'indirect' ratings. IR was assessed between 'indirect' ratings. CV was investigated by subgroup analysis based on prior experience in CTI for 'direct' and 'indirect' rating. RESULTS: We included 59 medical students to our study. IM showed moderate conformity ('direct' vs. 'indirect 1' ICC = 0.735, 95% CI: 0.554-0.843; 'direct' vs. 'indirect 2' ICC = 0.722, 95% CI 0.533-0.835) and good conformity between 'direct' vs. 'average indirect' rating (ICC = 0.764, 95% CI: 0.6-0.86). IR showed good conformity (ICC = 0.84, 95% CI: 0.707-0.91). CV was proven between subgroups in 'direct' (p = 0.037) and 'indirect' rating (p = 0.013). CONCLUSION: Results for IM suggest equivalence for 'direct' and 'indirect' ratings, while both IR and CV was demonstrated in both rating methods. Thus, the assessment scale seems a reliable method for rating trainees' performances 'directly' as well as 'indirectly'. It may help to objectify and facilitate the assessment of training of chest tube insertion.

Pilot evaluation of an objective structured assessment of technical skills tool for chest tube insertion.

Background: Chest tube insertion is a standard intervention for management of various injuries of the thorax. Efficient clinical training of this and similar bed-side procedures is equally demanded and improvable. Here, we propose a nouveau means of assessment and feedback using an Objective Structured Assessment of Technical Skills (OSATS) tool. The modified OSATS for chest drain insertion is evaluated in a pilot trial focusing on chest drain insertion. Methods: Participants in the pilot trial were medical students (3rd-6th year of studies, n=9), junior residents (1st-3rd post-graduate year, n=12), senior residents (4th-6th post-graduate year, n=14), and attending surgeons (n=6) from Heidelberg University. Chest drain insertions on a cadaveric porcine model were rated by experts with the modified OSATS score. Participants' performances were videotaped and subsequently rated by two remote experts (video rating). Primary aim was to assess criterion validity of the OSATS to distinguish experience levels. Results: Kruskal-Wallis test showed significant differences between means of scores between four groups stratified by previous experience in chest tube insertion (level 0: 22.1±3.2 vs. level 1: 26.8±2.8 vs. level 2: 35.4±2.2 vs. level 3: 41.0±2.0; p=0.002; p1,3=0.049, p0,3=0.005). However, if groups were stratified by formal professional level, no statistically significant distinction could be made using OSATS. Hence, the OSATS tool showed criterion validity for differentiation between experience levels. Conclusion: In the pilot study, the modified OSATS for chest tube insertion was apt to standardize expert rating and could be used to measure skill and to depict different experience levels. The OSATS will help facilitate training and assessment of chest drain insertion and could therefore improve surgical training for trauma situations. According to our data, the OSATS might be integrated into modern curricula.

Comparison of the clinical effectiveness of Bone Morphogenic Protein (BMP) -2 and -7 in the adjunct treatment of lower limb nonunions.

BACKGROUND: Substantial evidence exists demonstrating the individual effectiveness of both rhBMP-2 and -7 in the treatment of nonunions, data comparing the clinical effectiveness of adjunct rhBMP-2 and -7 remains scarce. Therefore, we examined our large single-center case series to compare the clinical effectiveness of both rhBMP-2 and -7 in non-union therapy aiming to answer: - Does a certain type of BMP have an advantageous effect on radiological outcome of applied lower limb non-union therapy? - Does application of a certain type of BMP have an advantageous effect on radiological outcome of infected lower limb nonunions? - Are there any additional risk factors associated with inferior outcome in context with an adjunct BMP treatment? HYPOTHESIS: Both BMPs have the same effect on the radiological outcome of surgically treated lower limb nonunions. PATIENTS AND METHODS: Single-center retrospective database analysis of a case series of patients with lower limb long bone nonunions receiving either a one- or two-stage (Masquelet-) procedure based on the "diamond concept" with application of rhBMP-2 or -7. The "diamond concept" summarizes core factors that need to be present to achieve bone healing. In particular, these factors relate to the optimization of the mechanical (stability) and biological environment (sufficient osteogenic and angiogenic cells, osteoconductive scaffolds and growth factors). All medical data from patients that received surgical treatment between 01/01/2010 and 31/12/2016 were assessed. In total, 356 patients were treated with BMPs and 156 patients 18 years or older with non-union of their tibia or femur having a follow-up of at least 1 year were included. Consolidation in context with type of rhBMP was compared and the influence of relevant risk factors assessed. RESULTS: Consolidation rate was significantly higher in patients treated with rhBMP-2 (rhBMP-2: 42/46 (91%) vs. rhBMP-7: 64/110 (58%); p<0.001). In particular, application of rhBMP-2 increased the likelihood of consolidation for tibial nonunions (OR 32.744; 95%CI: 2.909-368.544; p=0.005) and when used in two-stage therapy (OR 12.095; 95% CI: 2.744-53.314; p=0.001). Furthermore, regression modeling revealed a higher correlation between application of rhBMP-2 and osseous consolidation in infected nonunions (OR 61.062; 95% CI: 2.208-1688.475; p=0.015) than in aseptic nonunions (OR 4.787; 95% CI: 1.321-17.351; p=0.017). Risk factors negatively influencing the outcome of non-union treatment in context with rhBMPs were identified as active smoking (OR 0.357; 95% CI: 0.138-0.927; p=0.024), atrophic nonunion (OR 0.23; 95% CI: 0.061-0.869; p=0.030), higher BMI (OR 0.919; 95% CI: 0.846-0.998; p=0.046) and a larger defect size (OR 0.877; 95% CI: 0.784-0.98; p=0.021). DISCUSSION: Patients who received rhBMP-2 for the treatment of tibial nonunions and as part of the two-stage treatment had a significantly higher rate of healing compared to patients treated with rhBMP-7 regardless of infection. LEVEL OF EVIDENCE: III, retrospective case-control study.

Evaluation of App-Based Serious Gaming as a Training Method in Teaching Chest Tube Insertion to Medical Students: Randomized Controlled Trial.

BACKGROUND: The insertion of a chest tube should be as quick and accurate as possible to maximize the benefit and minimize possible complications for the patient. Therefore, comprehensive training and assessment before an emergency situation are essential for proficiency in chest tube insertion. Serious games have become more prevalent in surgical training because they enable students to study and train a procedure independently, and errors made have no effect on patients. However, up-to-date evidence regarding the effect of serious games on performance in procedures in emergency medicine remains scarce. OBJECTIVE: The aim of this study was to investigate the serious gaming approach in teaching medical students an emergency procedure (chest tube insertion) using the app Touch Surgery and a modified objective structural assessment of technical skills (OSATS). METHODS: In a prospective, rater-blinded, randomized controlled trial, medical students were randomized into two groups: intervention group or control group. Touch Surgery has been established as an innovative and cost-free app for mobile devices. The fully automatic software enables users to train medical procedures and afterwards self-assess their training effort. The module chest tube insertion teaches each key step in the insertion of a chest tube and enables users the meticulous application of a chest tube. In contrast, the module "Thoracocentesis" discusses a basic thoracocentesis. All students attended a lecture regarding chest tube insertion (regular curriculum) and afterwards received a Touch Surgery training lesson: intervention group used the module chest tube insertion and the control group used Thoracocentesis as control training. Participants' performance in chest tube insertion on a porcine model was rated on-site via blinded face-to-face rating and via video recordings using a modified OSATS tool. Afterwards, every participant received an individual questionnaire for self-evaluation. Here, trainees gave information about their individual training level, as well as previous experiences, gender, and hobbies. Primary end point was operative performance during chest tube insertion by direct observance. RESULTS: A total of 183 students enrolled, 116 students participated (63.4%), and 21 were excluded because of previous experiences in chest tube insertion. Students were randomized to the intervention group (49/95, 52%) and control group (46/95, 48%). The intervention group performed significantly better than the control group (Intervention group: 38.0 [I50=7.0] points; control group: 30.5 [I50=8.0] points; P<.001). The intervention group showed significantly improved economy of time and motion (P=.004), needed significantly less help (P<.001), and was more confident in handling of instruments (P<.001) than the control group. CONCLUSIONS: The results from this study show that serious games are a valid and effective tool in education of operative performance in chest tube insertion. We believe that serious games should be implemented in the surgical curriculum, as well as residency programs, in addition to traditional learning methods. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00009994; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00009994 (Archived by Webcite at http://www.webcitation.org/6ytWF1CWg).

Complications and risk management in the use of the reaming-irrigator-aspirator (RIA) system: RIA is a safe and reliable method in harvesting autologous bone graft.

BACKGROUND: Autologous bone grafting (ABG) remains the gold standard for augmentation of bone defects. The RIA system has become more prevalent, but evidence regarding risk management and complications remain scarce. This study presents the risk management and complications associated with RIA in the largest single-center case series to date. METHODS: All records, operative notes, lab data and radiographs of patients receiving a RIA procedure at Heidelberg´s University Hospital between 01/01/2010 and 31/12/2016 were reviewed. Multivariate logistic regression models adjusting for clinically relevant covariates were used to examine the respective relevance regarding the presence and absence of prolonged postoperative pain (PPP). RESULTS: A total of 341 RIA procedures on 306 patients were performed at our level-1 trauma center. The femur was the main donor site (98.53%; N = 336) whereas only in 1.47% (N = 5) the tibia was utilized. A total of 11 patients showed a relevant loss of hemoglobin requiring blood transfusion. A total of 22 patients suffered from PPP directly associated with the RIA procedure resulting in prevalence of 6.45%. The 6 major complications in our study were of diverse origin and all intraoperative complications took place in the early phase of the RIA procedure in our center (2010-2013). Our data revealed influence of sex (p = 0.0459) and age (p = 0.0596) on the criterion PPP. The favored model including sex and age resulted in an AUC of 66.2% (CI: 55.5%-76.9%). CONCLUSION: Perioperative blood loss remains a prevalent complication during RIA reaming. In addition, PPP occurs with a prevalence of 6.45%. This study showed a complication rate of 1.76%, emphasizing RIA´s overall safety and furthermore highlighting the need for vigilance in its application and prior extensive hands-on training of surgeons. Level of Evidence: II.