Dirk Stengel

Systematic review and meta-analysis of antibiotic therapy for bone and joint infections

We set out to evaluate the clinical efficacy of individual antibiotic agents for bone and joint infections in adults. Published and unpublished controlled trials reported between 1966 and 2000 were reviewed to determine if they involved random or quasi-random allocation to systemically administered antimicrobials or local antibiotic therapy for osteomyelitis and septic arthritis. Quiescence of infection after 1 year of follow-up was defined as the primary outcome measure. 22 trials containing 927 patients were eligible for final analysis. Varying proportions of the entire study population could be evaluated with respect to primary and secondary endpoints. Methodological quality was poor among most studies, and interpretability of results was further limited by small sample sizes, missing descriptions of patient populations and disease characteristics, and the frequent application of concomitant antibiotics. A trend towards improved, long-lasting infection control was observed in favour of a rifampicin-ciprofloxacin combination versus ciprofloxacin monotherapy for the treatment of staphylococcal infections related to orthopaedic devices (absolute risk difference [ARD] 28-9%; 95% CI -0.7 to 54.4%). Obviously unbalanced comparative studies showed some benefit of ticarcillin for bone infections caused by Pseudomonas species. No significant differences in therapeutic efficacy were found among trials comparing oral fluoroquinolones with intravenous beta-lactam drugs for both end-of-treatment (OR 0.8; 0.5 to 1.4) and long-term results (OR 1.3; 0.8 to 2.1). A variety of drugs was used as controls, thereby leading to inconsistent findings of drug-related side effects. Only one randomised trial was suitable to investigate the impact of polymethylmethacrylate gentamicin bead chains compared with parenteral antibiotics for skeletal infections, although this study was biased by patients receiving both combined local and systemic antibiotic therapy. Whereas intention-to-treat evaluation suggested a therapeutic advantage of systemic over local therapy, this trend diminished in the per-protocol analysis (1-year follow-up ARD -2.3;-17.5 to 10.8%). There exists little high-quality evidence on antibiotic therapy for osteomyelitis and septic arthritis. The observed heterogeneity among patient populations and medical and surgical treatment concepts preclude reliable inferences from the available data.

Tibial plateau fractures: functional outcome and incidence of osteoarthritis in 125 cases

Tibial plateau fractures occur due to a combination of axial loading and varus/valgus applied forces leading to articular depression, malalignment and an increased risk of posttraumatic osteoarthritis (OA) [14, 19]. When treating intra-articular fractures, the goal is to obtain a stable joint permitting early range of motion for cartilage nourishment and preservation [19]. Various treatment modalities have been used over the years, with mixed results. These include traction [3] or closed treatment with cast bracing [9, 16]. Surgical procedures including circular frames [1, 2, 18], percutaneous screw fixation [17], open reduction/internal fixation (ORIF) [1, 5, 6, 10, 28] and arthroplasty have also been advocated. More recent techniques such as the use of fixed angle devices [12, 20], arthroscopically-assisted reduction [8], calcium based cement augmentation [26, 29] and the use of novel grafting methods to address articular depression [4], constantly gain popularity amongst orthopaedic surgeons. Protection from weight bearing and length of immobilisation receive varied emphasis among authors [2, 11, 27]. Despite anatomical joint reconstruction, development of osteoarthritis may still occur secondary to the initial articular cartilage and meniscal injury [14, 21]. In young patients this could be detrimental as it can lead to total knee replacement (TKR) at an early age. In addition, these fractures may have significant socio-economic influence, mainly due to time taken off work. In order to assess the effect of these injuries on functional outcome and development of OA, we retrospectively reviewed a series of tibial plateau fractures treated in our institution.

Nonplatinum Topotecan Combinations Versus Topotecan Alone for Recurrent Ovarian Cancer: Results of a Phase III Study of the North-Eastern German Society of Gynecological Oncology Ovarian Cancer Study Group

PURPOSE The management of recurrent ovarian cancer remains controversial. Single-agent topotecan is an established treatment option, and preliminary evidence suggests improved tumor control by combining topotecan with etoposide or gemcitabine. PATIENTS AND METHODS Women with relapsed ovarian cancer after primary surgery and platinum-based chemotherapy were randomly assigned to topotecan monotherapy 1.25 mg/m(2)/d, topotecan 1.0 mg/m(2) plus oral etoposide 50 mg/d, or topotecan 0.5 mg/m(2)/d plus gemcitabine 800 mg/m(2) on day 1 and 600 mg/m(2) on day 8 every 3 weeks. Patients were stratified for platinum-refractory and platinum-sensitive disease according to a recurrence-free interval of less or more than 12 months, respectively. The primary end point was overall survival. Secondary end points included progression-free survival, objective response rates, toxicity, and quality of life (as measured by the European Organisation for Research and Treatment of Cancer [EORTC] 30-item Quality-of-Life Questionnaire). RESULTS The trial enrolled 502 patients with a mean age of 60.5 years (+/- 10.2 years), 208 of whom were platinum resistant. Median overall survival was 17.2 months (95% CI, 13.5 to 21.9 months) with topotecan, 17.8 months (95% CI, 13.7 to 20.0 months) with topotecan plus etoposide (log-rank P = .7647), and 15.2 months (95% CI, 11.3 to 20.9 months) with topotecan plus gemcitabine (log-rank P = .2344). Platinum-sensitive patients lived significantly longer than platinum-refractory patients (21.9 v 10.6 months). The median progression-free survival was 7.0, 7.8, and 6.3 months, respectively. Objective response rates were 27.8%, 36.1%, and 31.6%, respectively. Patients under combined treatment were at higher risk of severe thrombocytopenia. CONCLUSION Nonplatinum topotecan combinations do not provide a survival advantage over topotecan alone in women with relapsed ovarian cancer.

Blunt Liver Injuries in Polytrauma: Results from a Cohort Study with the Regular Use of Whole-body Helical Computed Tomography

The estimated prevalence of liver injury in patients with blunt multiple trauma ranges from 1% to 8%. The objective of this study was to investigate the profile of accompanying liver injury in a cohort of polytraumatized patients who had regularly undergone contrast-enhanced, whole-body helical computed tomography (CT). We enrolled consecutive patients admitted between September 1997 and January 2001 to a level I trauma center. Clinical baseline data were compiled as part of a nationwide trauma registry. Morphologic features were evaluated descriptively, whereas prognostic variables were assessed by logistic regression analysis. We identified 218 patients [149 men, mean age 35 ± 18 years, mean injury severity score (ISS) 35 ± 10], 55 of whom had sustained blunt liver trauma [25.2%, 95% confidence interval (CI) 19.6–31.5%]. The prevalence of Moore III to V lesions was 10.1%. There were 99 parenchymal contusions, 15 capsular tears, and 2 liver fractures. Surgery was required in 15 patients and was best predicted by the classification of the American Association for the Surgery of Trauma [odds ratio (OR) 3.91, 95% CI 1.59–9.61]. The mortality rate was 0.0035/person/day. Patients requiring surgical repair had fourfold increased relative odds of case fatality (OR 4.50, 95% CI 1.01–19.96). Sevenfold increased relative odds were observed if liver laceration was considered the leading injury (OR 7.17, 95% CI 1.17–43.97). The prevalence of liver lacerations among multiple-trauma patients is likely to be underestimated and must be determined by the independent application of reference standards, such as helical CT. High-grade hepatic injuries and the need for surgical repair are associated with poorer survival prognosis.

Survival trends and predictors of mortality in severe pelvic trauma: Estimates from the German Pelvic Trauma Registry Initiative

STUDY OBJECTIVE To determine longitudinal trends in mortality, and the contribution of specific injury characteristics and treatment modalities to the risk of a fatal outcome after severe and complex pelvic trauma. METHODS We studied 5048 patients with pelvic ring fractures enrolled in the German Pelvic Trauma Registry Initiative between 1991 and 1993, 1998 and 2000, and 2004 and 2006. Complete datasets were available for 5014 cases, including 508 complex injuries, defined as unstable fractures with severe peri-pelvic soft tissue and organ laceration. Multivariable mixed-effects logistic regression analysis was employed to evaluate the impact of demographic, injury- and treatment-associated variables on all-cause in-hospital mortality. RESULTS All-cause in-hospital mortality declined from 8% (39/466) in 1991 to 5% (33/638) in 2006. Controlling for age, Injury Severity Score, pelvic vessel injury, the need for emergency laparotomy, and application of a pelvic clamp, the odds ratio (OR) per annum was 0.94 (95% confidence interval [CI] 0.91-0.96). However, the risk of death did not decrease significantly in patients with complex injuries (OR 0.98, 95% CI 0.93-1.03). Raw mortality associated with this type of injury was 18% (95% CI 9-32%) in 2006. CONCLUSION In contrast to an overall decline in trauma mortality, complex pelvic ring injuries remain associated with a significant risk of death. Awareness of this potentially life-threatening condition should be increased amongst trauma care professionals, and early management protocols need to be implemented to improve the survival prognosis.

Die klinische Wertigkeit des ISO-C3D bei der Osteosynthese des Fersenbeins

ZusammenfassungIn einer prospektiven Studie mit 82 konsekutiven Patienten bei denen eine operative Versorgung einer intraartikulären Fersenbeinfraktur erfolgte, wurde ein Qualitätsvergleich zwischen konventioneller Durchleuchtung, intraoperativer Iso-C3D- und postoperativer CT-Bildgebung angestellt. Die in drei Sektoren eingeteilte Facies articularis talaris posterior (FATP) wurde von zwei unabhängigen Untersuchern auf verbliebene Gelenkstufen und fracture gaps untersucht. Analysiert wurde, ob der Operateur die ISO-C3D-Schnittbilder richtig befundete und intraoperativ Konsequenzen daraus zog. Es fanden sich keine signifikanten Unterschiede bei der Befundungssicherheit zwischen Iso-C3D- und CT-Bildgebung bezüglich verbliebener Gelenkstufen in den Sektoren I–III, sowie detektierter fracture gaps in den Sektoren I und III. Mit der konventionellen Durchleuchtung waren die Sektoren I und II überhaupt nicht zu beurteilen. In 6 Fällen (7,3%) wurde die Reposition intraoperativ nach einem Iso-C3D-Scan optimiert. Bei 10 Patienten wurden 12 Schraubenfehllagen (12,2% bzw. 14,6%) korrigiert. Die Ergebnisse zeigen, dass mit der intraoperativen Iso-C3D-Bildgebung eine hohe Befungssicherheit zu erreichen ist. Der Operateur erhält relevante Zusatzinformationen, die zu einer Änderung der OP-Strategie führen können. AbstractWe compared in a prospective study including 82 patients treated with ORIF of an intraarticular calcaneus fracture the quality of fluoroscopy, intraoperatively Iso-C3D and postoperative CT-scans. Therefore the posterior facet of the calcaneus (PFOC) was divided into three sectors. Joint steps and fracture gaps were detected by two independent investigators and statistically analysed. Another focus was to evaluate if the findings due to intraoperatively Iso-C3D assessment performed by the surgeon were correct and subsequently influenced the surgical procedure. There were no statistically differences between the Iso-C3D- and CT findings concerning joint steps or fracture gaps in PFOC sectors I–III. With fluoroscopy an assessment of the PFOC sectors I and II was not possible. In six cases (7.3%), intraoperative reduction was redone after performing an Iso-C3D scan. In ten cases, 12 malpositioned screws were replaced (12.2%/14.6%). These results suggest that intraoperative 3D Iso-C3D imaging provides a high diagnostic reliability. By careful assessment of the images the surgeons receive information which could lead to a change of the operative strategy.

[The clinical use of the ISO-C(3D) imaging system in calcaneus fracture surgery].

ZusammenfassungIn einer prospektiven Studie mit 82 konsekutiven Patienten bei denen eine operative Versorgung einer intraartikulären Fersenbeinfraktur erfolgte, wurde ein Qualitätsvergleich zwischen konventioneller Durchleuchtung, intraoperativer Iso-C3D- und postoperativer CT-Bildgebung angestellt. Die in drei Sektoren eingeteilte Facies articularis talaris posterior (FATP) wurde von zwei unabhängigen Untersuchern auf verbliebene Gelenkstufen und fracture gaps untersucht. Analysiert wurde, ob der Operateur die ISO-C3D-Schnittbilder richtig befundete und intraoperativ Konsequenzen daraus zog. Es fanden sich keine signifikanten Unterschiede bei der Befundungssicherheit zwischen Iso-C3D- und CT-Bildgebung bezüglich verbliebener Gelenkstufen in den Sektoren I–III, sowie detektierter fracture gaps in den Sektoren I und III. Mit der konventionellen Durchleuchtung waren die Sektoren I und II überhaupt nicht zu beurteilen. In 6 Fällen (7,3%) wurde die Reposition intraoperativ nach einem Iso-C3D-Scan optimiert. Bei 10 Patienten wurden 12 Schraubenfehllagen (12,2% bzw. 14,6%) korrigiert. Die Ergebnisse zeigen, dass mit der intraoperativen Iso-C3D-Bildgebung eine hohe Befungssicherheit zu erreichen ist. Der Operateur erhält relevante Zusatzinformationen, die zu einer Änderung der OP-Strategie führen können. AbstractWe compared in a prospective study including 82 patients treated with ORIF of an intraarticular calcaneus fracture the quality of fluoroscopy, intraoperatively Iso-C3D and postoperative CT-scans. Therefore the posterior facet of the calcaneus (PFOC) was divided into three sectors. Joint steps and fracture gaps were detected by two independent investigators and statistically analysed. Another focus was to evaluate if the findings due to intraoperatively Iso-C3D assessment performed by the surgeon were correct and subsequently influenced the surgical procedure. There were no statistically differences between the Iso-C3D- and CT findings concerning joint steps or fracture gaps in PFOC sectors I–III. With fluoroscopy an assessment of the PFOC sectors I and II was not possible. In six cases (7.3%), intraoperative reduction was redone after performing an Iso-C3D scan. In ten cases, 12 malpositioned screws were replaced (12.2%/14.6%). These results suggest that intraoperative 3D Iso-C3D imaging provides a high diagnostic reliability. By careful assessment of the images the surgeons receive information which could lead to a change of the operative strategy.

Topotecan Weekly Versus Conventional 5-Day Schedule in Patients With Platinum-Resistant Ovarian Cancer: A Randomized Multicenter Phase II Trial of the North-Eastern German Society of Gynecological Oncology Ovarian Cancer Study Group

PURPOSE Weekly administration of topotecan (Tw) is less toxic and widely considered a better treatment option than conventional 5-day therapy (Tc) in women with platinum-resistant recurrent ovarian cancer. We conducted a randomized phase II trial (TOWER [Topotecan Weekly Versus Conventional 5-Day Schedule in Patients With Platinum-Resistant Ovarian Cancer]) to better define the ratio between benefits and risks with either treatment approach. PATIENTS AND METHODS Patients were randomly assigned to two independent two-stage protocols of Tw (4 mg/m(2)/wk administered on days 1, 8, and 15) or Tc (1.25 mg/m(2)/d on days 1 to 5). We evaluated risk ratios (RRs) for the primary end point of clinical benefit (complete response, partial response, and stable disease), the duration of progression-free survival (PFS) and overall survival (OS), associated hazard ratios (HRs), and RRs of toxicity with 95% CIs. RESULTS In total, 194 patients were randomly assigned at 54 centers to Tw (n = 97) or Tc (n = 97). Clinical benefit was observed in 36 of 76 (47%; 95% CI, 36% to 59%) Tw and 46 of 80 (58%; 95% CI, 46% to 68%) Tc patients (RR, 1.21; 95% CI, 0.90 to 1.64; P = .205). Patients in the Tw group had a slightly shorter PFS (HR, 1.29; 95% CI, 0.96 to 1.76) but similar OS (HR, 1.04; 95% CI, 0.74 to 1.45) compared with Tc. Tw was associated with significantly lower risks of anemia (RR, 0.35; 95% CI, 0.16 to 0.79), neutropenia (RR, 0.38; 95% CI, 0.23 to 0.65), and thrombocytopenia (RR, 0.23; 95% CI, 0.09 to 0.57). CONCLUSION With regard to effectiveness in terms of response and PFS, Tc remains the standard of care in patients with platinum-resistant recurrent ovarian cancer. However, comparable OS rates and a favorable toxicity profile make Tw another viable treatment option in this setting.

Comparison of Handheld Computer-assisted and Conventional Paper Chart Documentation of Medical Records: A Randomized, Controlled Trial

BACKGROUND Daily documentation and maintenance of medical record quality is a crucial issue in orthopaedic surgery. The purpose of the present study was to determine whether the introduction of a handheld computer could improve both the quantitative and qualitative aspects of medical records. METHODS A series of consecutive patients who were admitted for the first time to a thirty-six-bed orthopaedic ward of an academic teaching hospital for a planned operation or any other treatment of an acute injury or chronic condition were randomized to daily documentation of their clinical charts on a handheld computer or on conventional paper forms. The electronic documentation consisted of a specially designed software package on a handheld computer for bedside use with structured decision trees for examination, obtaining a history, and coding. In the control arm, chart notes were compiled on standard paper forms and were subsequently entered into the hospitals information system. The number of documented ICD (International Classification of Diseases) diagnoses was the primary end point for sample size calculations. All patient charts were reread by an expert panel consisting of two surgeons and the surgical quality assurance manager. These experts assigned quality ratings to the different documentation systems by scrutinizing the extent and accuracy of the patient histories and the physical findings as assessed by daily chart notes. RESULTS Eighty patients were randomized to one of the two documentation arms, and seventy-eight (forty-seven men and thirty-one women) of them were eligible for final analysis. Documentation with the handheld computer increased the median number of diagnoses per patients from four to nine (p < 0.0001), but it produced some overcoding for false or redundant items. Documentation quality ratings improved significantly with the introduction of the handheld device (p < 0.01) with respect to the correct assessment of a patients progress and translation into ICD diagnoses. Various learning curve effects were observed with different operators. Study physicians assigned slightly better practicability ratings to the handheld device. CONCLUSIONS The preliminary data from this study suggest that handheld computers may improve the quality of hospital charts in orthopaedic surgery. LEVEL OF EVIDENCE Therapeutic study, Level I-1a (randomized controlled trial [significant difference]). See Instructions to Authors for a complete description of levels of evidence.

Retrograde fixation of distal femoral fractures: results using a new nail system.

Objectives To investigate the management and outcome of distal femur fractures treated with retrograde nailing. Design Prospective. Setting Unfallkrankenhaus Berlin, level I trauma center. Patients A consecutive series of 47 patients with 48 fractures of the distal femur (37 fractures AO type A and 11 fractures type C) operated on between May 1999 and June 2000. Outcome Measures Outcome was assessed by using standard radiographic criteria of time to union, incidence of infection, malunion, and knee function (Leung score). Results After an average time of 33 months (range 12–37 months), 44 patients were reexamined. Three patients were lost to follow-up. The average age was 44 years (range 17–92 years). Of patients, 19 sustained polytrauma, and 10 had associated soft tissue damage. A total of 34 patients underwent primary definitive osteosynthesis within 12 hours after trauma. All fractures healed after an average of 12.6 weeks (range 9–17 weeks). Seven complications were noted—three related to severity of injury (one deep venous thrombosis, two leg length shortenings of 1.5 cm and 2.5 cm) and four related to the operation (insufficient counterboring of the nail in two patients, one malreduction, one iatrogenic fracture of femur shaft). There was no relevant difference between type A and type C fractures in functional, clinical, or radiographic outcomes. Conclusions Retrograde nailing is recommended as an alternative method to plate osteosynthesis in stabilizing distal femoral fractures, particularly in type C fractures.