Sabine Goldhahn

Patient benefit from endoscopically assisted fixation of condylar neck fractures--a randomized controlled trial.

PURPOSE Owing to the risk of facial nerve damage and the creation of visible scars, surgical treatment of condylar mandible fractures using an extraoral approach remains controversial. The transoral endoscopically assisted approach of condylar fractures has been reported to avoid these complications. A prospective, randomized controlled, multicenter trial was performed to quantify the patient benefit after open reduction and internal fixation of condylar mandible fractures using endoscopically assisted treatment compared with surgical treatment without endoscopic assistance. PATIENTS AND METHODS Patients with dislocated uni-/bilateral condylar neck fractures were randomized to receive either nonendoscopic open reduction and internal fixation using an extraoral (submandibular, preauricular, retromandibular) approach or a transoral endoscopic procedure. The primary functional outcome measure was investigated using the asymmetric Helkimo dysfunction score at 8 to 12 weeks and 1 year after surgery. RESULTS A total of 74 patients were recruited between 2003 and 2006; the nonendoscopic extraoral group included 34 patients and the endoscopically assisted open reduction group included 40 patients. Comparable functional results were noted in both groups without any statistical significance. Endoscope-assisted treatment proved to be more time consuming. For the extraoral group, visible scars were rated by most of these patients as being cosmetically acceptable; however, a greater number of facial nerve injuries were reported. CONCLUSIONS The treatment of condylar mandible fractures with a minimal invasive endoscopically assisted technique is reliable and may offer advantages for selected cases, particularly concerning the lower occurrence of facial nerve damage.

Complication Reporting in Orthopaedic Trials

BACKGROUND The nature and frequency of complications during or after orthopaedic interventions represent critical clinical information for safety evaluations, which are required for the development or improvement of orthopaedic care. The goal of this systematic review was to check whether essential data regarding the assessment of the prevalence, severity, and characteristics of complications related to orthopaedic interventions are consistently provided by the authors of papers on randomized controlled trials. METHODS Five major peer-reviewed orthopaedic journals were screened for randomized controlled trials published between January 2006 and July 2007. All relevant papers were obtained, anonymized, and evaluated by two external reviewers. A checklist consisting of three main parts (definition, evaluation, and reporting) was developed and applied for the assessment of complication reporting. The results were stratified into surgical and nonsurgical categories. RESULTS One hundred and twelve randomized controlled trials were identified. Although complications were included as trial outcomes in two-thirds of the studies, clear definitions of anticipated complications were provided in only eight trials. In 83% of the trials, the person or group assessing the complications was not identified. No trial involved a data safety review board for assessment and classification of complications. CONCLUSIONS The lack of homogeneity among the published studies that we reviewed indicates that improvement in the reporting of complications in orthopaedic clinical trials is necessary. A standardized protocol for assessing and reporting complications should be developed and endorsed by professional organizations and, most importantly, by clinical investigators.

Cross-cultural adaptation and validation of the Japanese Knee Injury and Osteoarthritis Outcome Score (KOOS)

BackgroundIn Japan, only few cross-culturally adapted, internationally used orthopaedic patient self-assessed outcome scores are available. In addition, the high incidence of knee osteoarthritis (OA) suggests the need for validated outcome measures such as the widely used Knee Injury and Osteoarthritis Outcome Score (KOOS) for Japanese populations. The purpose of this study was to provide a cross-culturally adapted and validated KOOS questionnaire for further use in national and international clinical projects involving Japanese patients.MethodsThe Japanese KOOS was developed according to the standard cross-cultural adaptation guidelines. For validation, the KOOS was tested on 58 patients diagnosed with OA. Reliability was tested using the intraclass correlation coefficient (ICC). Internal consistency or homogeneity was assessed using Cronbach’s alpha. Construct validity was evaluated by quantifying the correlation between the KOOS and the Japanese OKS and SF-36 questionnaires with Spearmann’s correlation coefficients.ResultsNo major difficulties were encountered during the translation and pre-testing stages. All five KOOS subscales showed adequate reproducibility with ICC values greater than 0.85, high internal consistency with Cronbach’s alpha values around 0.90, and high Spearmann’s coefficients over 0.50 signifying good correlation between the KOOS subscales and the OKS as well as the majority of the established subscales of the SF-36. No floor and ceiling effects were observed for the five subscales.ConclusionsOur validated Japanese KOOS is a reliable and stable outcomes measure that provides a valuable basis for national and international clinical projects focusing on patient-based assessments in knee OA.

Endoscope-assisted transoral reduction and internal fixation versus closed treatment of mandibular condylar process fractures--a prospective double-center study.

PURPOSE The aim of this international AO-study was to compare the functional outcome after open versus closed treatment of mandibular condylar neck fractures. PATIENTS AND METHODS A prospective comparative study with two follow-ups (FU) at 8-12 weeks and 1 year was undertaken in two clinics, which exclusively privileged either surgical or conservative treatment due to different therapeutic agendas. Patients from clinic 1 (ENDO group) received endoscope-assisted transoral open reduction and internal fixation, whereas patients from clinic 2 (CONS group) were treated conservatively without surgery. Patients with unilateral condylar neck fractures showing one or more of the following conditions were included: displacement of the condyle with an inclination >30° and/or severe functional impairment such as malocclusion or open bite, with or without dislocation of the condylar fragment; severe pain upon palpation or movement, and/or vertical shortening of the ascending ramus. High or intracapsular condylar neck fractures were excluded. RESULTS 75 patients (44 CONS and 31 ENDO patients) with condylar neck fractures were included in this study. The Asymmetric Helkimo Dysfunction Score (A-HDS) was slightly lower in the CONS group than in the ENDO group at the 8-12-week FU, corresponding to better function on the short-term. At the 1-year FU, however, there were slightly better values in the ENDO group. For the Clinical Dysfunction Index (Di) and the Anamnestic Dysfunction Index (Ai), CONS patients had a better outcome than ENDO patients at the 8-12 week FU, ie, a higher proportion of ENDO patients had severe symptoms due to the operative trauma. Yet these symptoms improved by one year, finishing with a significant higher proportion of symptom-free patients in the ENDO group. In addition, these patients had better values for the Index for Occlusion and Articulation Disturbance (Oi) at both FU examinations, ie, the proportion of patients without any occlusal disturbances was significantly higher in the ENDO group. On average, the duration of postoperative maxillo-mandibular fixation (MMF) was 3 times longer for the CONS group than for the ENDO group (33 vs. 11 days). CONCLUSION Both treatment options may yield acceptable results for displaced condylar neck fractures. Especially in patients with severe malocclusion directly after trauma, however, endoscope-assisted transoral open reduction and fixation seems to be the appropriate treatment for prevention of occlusal disturbances during FU.

A New Injectable Brushite Cement: First Results in Distal Radius and Proximal Tibia Fractures.

Objective:The restoration of metaphyseal defects remains a challenge for the treating surgeon. Although injectable brushite cements may help to refill bone defects stabilized with internal fixation, human data remains unavailable. The main goal of this prospective multicenter study was to observe the performance of this material in a clinical setting.Patients and Methods:The study conducted in seven trauma units included closed metaphyseal distal radius and proximal tibia fractures with bone defects, stabilized with internal fixation and subsequent filling with brushite cement. At 6- and 12-month follow-ups, patient satisfaction (visual analog scale [VAS]) was recorded, as well as complications.Results:Thirty-eight proximal tibia fractures and 37 patients with distal radius fractures were included. Overall patient satisfaction with the treatment was high (mean VAS = 92 and 91 for proximal tibia and distal radius, respectively), despite the loss of reduction being described in 11% of proximal tibia and 24% of distal radius fractures; the majority of them included severe fracture types. Radiological evaluation showed postoperative cement leakage in 20 cases, where the majority occurred at the distal radius (n = 15). In 13 distal radius fractures, the leakage was resorbed by the final examination.Conclusion:The tested material showed good outcome in the majority of patients and adequate resorption characteristics, even in the case of extravasation. Stable internal fixation, sufficient bone quality, and no contact between the cement and joint are essential requirements for chronOS Inject, which can be considered as an alternative to existing augmentation materials.

How to document and report orthopedic complications in clinical studies? A proposal for standardization

IntroductionThe documentation of complications is critical for the evaluation of therapeutic interventions in orthopedics. However, there is a lack of accepted methodological standardization and definitions. We propose a concept to support the consensus development of a standardized management and classification of complications in clinical research.MethodsComplication events are examined regarding their clinical presentation, their timing of occurrence as well as their potential causal interrelationship for any given patient. Their clinical presentation is distinguished by their likely triggers, their therapeutic management, and their outcome. Complications are events (including relevant deviations from their expected healing process) that are harmful to patients and can be described as local to the treated injury/disease or systemic (when they affect the rest of the body). The treatment of a complication, e.g. by way of an unplanned surgical intervention, and its outcome should be carefully documented. Complication review boards with independent clinicians should be established to validate complication records.Application and relevanceIn this proposal, a number of complication examples are presented to illustrate the concept and demonstrate its practical use. This management and classification system has already proven valuable in the documentation and analysis of complication data from a number of published clinical studies. Because of this new standardized assessment process, it facilitates the communication of complications between clinicians and researchers, and helps to develop clear definitions for specific orthopedic complications.

Does osteoporosis increase complication risk in surgical fracture treatment? A protocol combining new endpoints for two prospective multicentre open cohort studies

BackgroundWith an ever-increasing elderly population, orthopaedic surgeons are faced with treating a high number of fragility fractures. Biomechanical tests have demonstrated the potential role of osteoporosis in the increased risk of fracture fixation complications, yet this has not been sufficiently proven in clinical practice. Based on this knowledge, two clinical studies were designed to investigate the influence of local bone quality on the occurrence of complications in elderly patients with distal radius and proximal humerus fractures treated by open reduction and internal fixation.Methods/DesignThe studies were planned using a prospective multicentre open cohort design and included patients between 50 and 90 years of age. Distal radius and proximal humerus fractures were treated with locking compression 2.4 mm and proximal humerus internal locking plates, respectively. Follow-up examinations were planned for 6 weeks, 3 and 12 months as well as a telephone interview at 6 months. The primary outcome focuses on the occurrence of at least one local bone quality related complication. Local bone quality is determined by measuring bone mineral density and bone mineral content at the contralateral radius. Primary complications are categorised according to predefined factors directly related to the bone/fracture or the implant/surgical technique. Secondary outcomes include the documentation of soft tissue/wound or general/systemic complications, clinical assessment of range of motion, and patient-rated evaluations of upper limb function and quality of life using both objective and subjective measures.DiscussionThe prospective multicentre open cohort studies will determine the value of local bone quality as measured by bone mineral density and content, and compare the quality of local bone of patients who experience a complication (cases) following surgery with that of patients who do not (controls). These measurements are novel and objective alternatives to what is currently used.Trial registration numbersClinical Trials.gov NCT01144208 and NCT01143675

Pathways to evidence-based knowledge in orthopaedic surgery: an international survey of AO course participants

The aim of this study was to gain information about how orthopaedic surgeons use evidence-based literature and how this is influenced by their knowledge of evidence-based medicine. We administered a questionnaire to participants at courses of the Association for the Study of Internal Fixation (AO-ASIF) in Davos, Switzerland, in December 2003. Special attention was paid to the surgeons’ educational level, affiliations, and the infrastructure and evidence sources they used. In addition, we tested participants on their knowledge and attitude to evidence-based orthopaedic surgery (EBOS). Of 1,274 course participants, 456 completed the questionnaire. Of 446 respondents, 300 had heard of EBOS, but only 45% could define it correctly. Nearly two thirds identified scientific publications as their main source of scientific knowledge. The respondents’ attitudes to and awareness of EBOS principles was high, but it did not influence their manner of searching for scientific information or their trust in various sources of recommendations.RésuméLe but de ce travail était de trouver de l’information sur l’utilisation par les chirurgiens orthopédistes de la littérature basée sur des preuves et comment cela pouvait être influencé par leur connaissance de la médecine basée sur des preuves. Nous avons donné un questionnaire aux participants au Cours de l’Association pour l’Étude de la Fixation Interne (AO-ASIF) à Davos en décembre 2003.Une attention spéciale a été portée au niveau pédagogique des chirurgiens, leurs affiliations, l’infrastructure et les sources de preuves qu’ils ont utilisé. De plus, nous avons testé les participants sur leurs connaissances et leur attitude envers la chirurgie orthopédique basée sur des preuves (EBOS). Sur 1,274 participants au cours, 456 ont complété le questionnaire. Des 446 participants interrogées 300 avaient entendu parler d’EBOS, mais seulement 45% pouvaient le définir correctement. Presque deux tiers des participants interrogés ont identifié les publications scientifiques comme leur principale source de connaissance scientifique. Chez les participants interrogés, la conscience des principes EBOS était haute, mais cela n’a pas influencé leur manière de chercher l’information scientifique ou leur confiance dans les sources de recommandations.

Multilingual cross-cultural adaptation of the patient-rated wrist evaluation (PRWE) into Czech, French, Hungarian, Italian, Portuguese (Brazil), Russian and Ukrainian

The use of patient-reported outcome questionnaires is recommended in studies of the orthopaedic field. Reliable, validated tools are necessary to ensure the comparability of results across different studies, centers, and countries. The patient-rated wrist evaluation (PRWE) is a widely accepted and commonly used outcome measure in the self-evaluation after distal radius fractures. The cross-cultural adaptation of PRWE was performed according to international guidelines, following prescribed six stages: translation, synthesis, back-translation, expert committee review, pre-testing, and submission of documentation. PRWE versions were achieved without any substantive difficulty in all seven languages. Cross-cultural adaptation aims “to attain semantic, idiomatic, experiential and conceptual equivalence between the source and target questionnaires”. The present paper provides such adaptation of the PRWE in seven different languages, making this tool available for an additional nearly half a billion potential users.

Reliability, validity and responsiveness of the Spanish Manchester-Oxford Foot Questionnaire (MOXFQ) in patients with foot or ankle surgery

BACKGROUND The Manchester-Oxford Foot Questionnaire (MOXFQ) has been validated in Spanish for use in patients undergoing foot and ankle surgery. METHODS 120 patients completed the MOXFQ and the SF-36 before surgery and 6 and 12 months postoperative. Surgeons completed the American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System. Psychometric properties were assessed for all three MOXFQ dimensions, and for the MOXFQ Index. RESULTS The Spanish MOXFQ demonstrated consistency with Cronbachs alpha values between 0.65 and 0.90, and reliability ([ICCs] >0.95). It shows a moderate to strong correlation between the Walking/standing dimension and the related domains of the SF-36 (|r|>0.6), the AOFAS Ankle-Hindfoot Scale (|r|>0.47) and Hallux-MTP-IP Scale (|r|>0.64). Responsiveness was excellent, (effect sizes >2.1). The respective minimal detectable change (MDC90) was 14.18 for the MOXFQ Index. CONCLUSIONS The Spanish version of the MOXFQ showed good psychometric properties in patients with foot and ankle disorders.