Responsiveness of the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Oxford Knee Score (OKS) in Japanese patients with high tibial osteotomy.

BACKGROUND: To assess responsiveness of the Japanese Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Oxford Knee Score (OKS) in patients undergoing open-wedge HTO to treat knee osteoarthritis and/or osteonecrosis. METHODS: Patients completed a set of questionnaires before HTO surgery (baseline) and 1 year after surgery. The questionnaires comprised the validated Japanese versions of the KOOS, the OKS, and the SF-36v2 and a visual analogue scale (VAS) for local knee pain and general pain. The treating surgeon completed the Japanese Orthopedic Association (JOA) score for osteoarthritic knees. The study included 119 patients aged 64.7 ± 8.3, 116 were followed at 1 year. 90 patients had knee osteoarthritis (OA) solely. 28 patients suffered from both OA and osteonecrosis (ON); one patient had ON only. Responsiveness to change was assessed using the effect size (ES) between the baseline and the 1-year postoperative assessment and standardized response mean. A distribution-based approach was used to determine the minimally detectable change (MDC95) for the KOOS subscales, and the OKS. RESULTS: All instruments demonstrated statistically significant changes between the preoperative assessments and one year after surgery. All changes showed an improvement in score, but the condition-specific measures revealed higher responsiveness than the generic measures. All KOOS subscales, the OKS, the local pain VAS, and the JOA score showed large ESs (ES > 1.24) and SRMs (SRM>1.04). At a 95% confidence level, the respective MDCs were 15.83, 18.94, 15.22, 18.99 and 17.23 for the KOOS-Pain, KOOS-Symptoms, KOOS-ADL, KOOS-Sport/Rec, and KOOS-QOL subscales, respectively. The MDC95 for the OKS was 8.29. CONCLUSIONS: Both, the KOOS and OKS are responsive for use in Japanese-speaking patients with knee osteoarthritis and/or osteonecrosis who are undergoing HTO.

[Titanium or steel as osteosynthesis material : Systematic literature search for clinical evidence]. / Titan oder Stahl als Osteosynthesematerial : Systematische Literaturrecherche über die klinische Evidenz.

BACKGROUND: The selection of the appropriate implant material, stainless steel or titanium, is still the decision of the surgeon and/or the affiliated institution. Additionally, remarkable international differences can be found between the different markets, which cannot really be explained. OBJECTIVE: A systematic literature search was performed to verify whether there is clinical evidence for the preference of one material over the other. MATERIAL AND METHODS: The systematic literature search was performed utilizing the internet databases PubMed, Cochrane and Web of Science. Comparative studies were included that reported on adult patients with osteosynthesis of extremities after trauma using either stainless steel or titanium implants. Information was extracted about infection rates, incidence of clinically relevant allergies, problems with implant removal and other complications. RESULTS: A total of 18 publications were identified to be eligible and 2 referenced articles were added. In summary, there is insufficient clinical evidence that the use of titanium or steel implants has a positive or negative effect on fracture healing, shows different rates of allergies, different rates of infections or mechanical failure. No supporting evidence could be identified for the difficulties with removal of titanium implants reported by surgeons. CONCLUSION: This systematic literature search did not provide any clinical evidence for material-related differences between titanium or stainless steel implants for fracture fixation. Based on the current clinical evidence both titanium and steel implants can be considered to be of equal value. The reported difficulties with implant removal are not reflected in the published literature.

A refined definition improves the measurement reliability of the tip-apex distance.

BACKGROUND: Tip-apex distance (TAD) is reported as a good predictor for cut-outs of lag screws and spiral blades in the treatment of intertrochanteric fractures, and surgeons are advised to strive for TAD within 20 mm. However, the femoral neck axis and the position of the lower limb in the lateral radiograph are not clearly defined and can lead to measurement errors. We propose a refined TAD by defining these factors. The objective of this study was to analyze the reliability of this refined TAD. METHODS: The radiographs of 130 prospective cases with unstable trochanteric fractures were used for the analysis of the refined TAD. The refined TAD was independently measured by 2 raters with clinical experience of more than 10 years (rater 1, 2) and 2 raters with much less clinical experience (rater 3, 4) after they received a training about the new measurement method. Intraclass correlation coefficient (ICC [2,4]) was calculated to assess the interrater reliability. RESULTS: The mean refined TADs were 18.2:18.4:18.2:18.2 mm for rater 1:2:3:4. There was a strong correlation among all four raters (ICC 0.998, (95% CI: 0.998, 0.999). CONCLUSIONS: Regardless of the clinical experience of raters, the refined TAD is a reliable tool and can be used to develop new TAD recommendations for predicting failure of fixation. Future studies with larger samples are needed to evaluate the predictive value of the refined TAD.

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 Cronbach's 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.

Does obesity and nicotine abuse influence the outcome and complication rate after open-wedge high tibial osteotomy? A retrospective evaluation of five hundred and thirty three patients.

PURPOSE: Nicotine abuse and obesity are well-known factors leading to common post-operative complications. However, their influence on the outcome after high tibial osteotomy is controversial. Thus, the aim of this study was to evaluate their effect on the clinical outcome with particular regard to bone non-union and local complications. METHODS: The functional outcome after open-wedge high tibial osteotomy using the TomoFix® plate was assessed by means of the 12-item Oxford knee score in a multicentre study. In addition the intra- and post-operative complications were determined. RESULTS: Of 533 eligible patients, 386 were interviewed after a mean follow-up of 3.6 years. The median Oxford knee score was 43 points (max. 48 points). Six per cent of these patients experienced at least one local post-operative complication. Patients with a body mass index (BMI) of up to 25 and between 25 and 30 had a higher mean score by 3.5 and 1.8 points, respectively, compared with those having a BMI of more than 30 showing a score of 37.5. No correlation was observed between smoking and the functional outcome. Smoking habits, BMI, the absolute patient weight and the interaction term between smoking and BMI were not significant with reference to the complication rate. CONCLUSIONS: This study reveals favourable mid-term results after high tibial osteotomy in varus osteoarthritis even in patients who smoked and obese patients. The indication in patients with a BMI above 30 should be handled with care due to the slightly inferior outcome, although the complication rate was not increased in these patients.

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

INTRODUCTION: The 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. METHODS: Complication 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 RELEVANCE: In 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.

Outcome after high tibial open-wedge osteotomy: a retrospective evaluation of 533 patients.

PURPOSE: Open-wedge valgus high tibial osteotomy is a well-established procedure in the management of medial osteoarthritis of the knee. In recent years, improved osteotomy and fixation methods have led to an increased use of this technique. The aim of this study was to identify predictive parameters for the clinical outcome after valgus high tibial osteotomy. METHODS: A multicentre case series involving retrospective capture of baseline data and prospective outcome assessment of patients with knee OA who underwent an osteotomy using Tomofix(®) plate was conducted. Functional outcome was assessed using Oxford 12-item Knee Score. RESULTS: Before surgery, the majority of patients had grade III (52%) and grade IV (33%) lesions according to Outerbridge classification. Three hundred and eighty-six of 533 eligible patients were interviewed for follow-up after an average of 3.6 years. The mean Oxford Knee Score was 43 points. Six per cent experienced at least one local postoperative complication. There was a tendency towards lower score results in patients with a higher preoperative degree of the medial cartilage lesion. No correlation between patient age and the Oxford Knee Score was observed. CONCLUSION: Being male, being operated by an experienced surgeon, having no intake of pain medication at follow-up and having no postoperative complication are positive predictors of the Oxford Knee Score up to 5 years after surgery. This study reveals favourable midterm results after valgus high tibial osteotomy in varus osteoarthritis, even in older patients with high degree of cartilage damage. LEVEL OF EVIDENCE: II.

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.

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.

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

BACKGROUND: In 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. METHODS: The 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. RESULTS: No 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. CONCLUSIONS: Our 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.

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

BACKGROUND: With 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/DESIGN: The 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. DISCUSSION: The 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 NUMBERS: Clinical Trials.gov NCT01144208 and NCT01143675.

Outcome after treatment of osteoarthritis with open-wedge high-tibial osteotomy with a plate: 2-year results of a Japanese cohort study.

PURPOSE: This prospective multicenter study evaluated patient reported outcomes (PROs) in individuals undergoing medial open-wedge high-tibial osteotomy (OWHTO) with plate stabilization compared to conservative care or no treatment. METHODS: One hundred eighteen of 148 patients older than 40 years were elected for OWHTO with plate treatment. Thirty patients declined surgery and were followed as a conservative group. The primary outcome measure was the Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 years. Secondary measures included Oxford knee score, Western Ontario and McMaster Universities osteoarthritis index, range of motion (ROM), joint space width (JSW), femorotibial angle (FTA), and weight-bearing line ratio (WBLR). RESULTS: Patient enrollment and baseline characteristics were heterogeneously distributed and led to group characteristics that were not comparable. Therefore, the comparison of the KOOS between the groups showing no differences must be treated with caution. In the OWHTO plate group, all PROs and the ROM significantly improved between baseline and 2-year follow-up. JSW remained stable in the OWHTO group. The FTA and WBLR significantly changed from a mean of 179.3 (95% confidence interval (CI): 178.7, 179.9) to 169.8 (95% CI: 169.2, 170.5) and from 23.1 (95% CI: 20.7, 25.5) to 62.4 (95% CI 59.0, 65.8), respectively. Treatment failure with conversion to total knee arthroplasty occurred in 1% of the OWHTO group; and in the conservative group, 10% converted to HTO or knee arthroplasty. CONCLUSIONS: OWHTO with plate leads to significant improvement of PROs and function 2 years after intervention and demonstrates reliable mechanical axis correction with subsequent shift of weight-bearing.

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.

Volumetric alterations around single-tooth implants using the socket-shield technique: preliminary results of a prospective case series.

OBJECTIVE: To demonstrate in a prospective cohort study that immediate implantation and provisionalization in combination with the socket-shield technique will result in volume stability of the mucosa adherent to the inserted implant. MATERIAL AND METHODS: Patients with an indication for a single tooth implant underwent application of the socket-shield technique and immediate implantation of a provisional implant crown. A noninvasive volumetric measurement was performed according to the method described by Windisch et al (2007) at baseline and 12 weeks later. The influence of potential confounders was evaluated. Patients rated their satisfaction with the treatment, fitting accuracy of implant, intraoperative discomfort, postoperative pain, and ability to chew soft and hard foods using visual analog scales. RESULTS: Fifteen patients with a mean age of 49.2 ± 11.9 years were enrolled in the study. All implant sites showed uneventful healing and no socket-shield exposures were observed. The soft tissue volume change assessed with the mean distance change was < 0.5 mm in all cases (-0.07 ± 0.16; range -0.37 to +0.32). A slight but significant influence of the buccal bone plate width on the soft tissue volume change was observed (b = 0.25; P = 0.037). No influence was found for apical bone height, width of gingival tissue, buccal recession or probing depths. The patients were highly satisfied with their treatment as well as with the pain and functional outcomes. CONCLUSIONS: Based on preliminary data, preservation of a buccal root segment in conjunction with immediate implant placement and provisionalization can minimize buccal contour changes after tooth extraction on a short-term basis.

Optimizing intraoperative imaging during proximal femoral fracture fixation - a performance improvement program for surgeons.

INTRODUCTION: Formal training for surgeons regarding intraoperative imaging is lacking. This project investigated the effect of an educational intervention focusing on obtaining and assessing a standardized lateral view of the proximal femur during intramedullary nailing of a pertrochanteric fracture. MATERIALS AND METHODS: Anatomical landmarks of the proximal femur that can be identified using intraoperative fluoroscopy and criteria for image quality, i.e. quality of projection were defined in a consensus process, followed by the development of educational materials and a 7-item checklist. Five surgeons from 5 Trauma Centers in 4 countries participated. Each surgeon a) assessed 5 of their own retrospective cases and 5 retrospective cases from 4 colleagues from their clinic, b) viewed an educational video and poster and re-assessed the same cases, and c) assessed the intraoperative images of 5 prospectively collected consecutive cases of their own and of colleagues afterwards. RESULTS: The percentage of positive ratings for image quality increased from 72% prior to educational intervention to 88% after intervention (p<0.001), and number of "not assessable" images decreased significantly. Percentage agreement between surgeons on the assessments increased from 75% to 87%. The proportion of best possible ratings for fracture reduction and implant position increased from 58% to 72% and from 49% to 66%, respectively. Percentage agreement between surgeons on assessment of reduction and implant position increased. DISCUSSION AND CONCLUSIONS: A focused educational intervention can improve surgeons' ability to obtain and assess lateral view intraoperative images of the proximal femur and can improve the quality of reduction and implant positioning.

The Great Unknown-A systematic literature review about risk associated with intraoperative imaging during orthopaedic surgeries.

INTRODUCTION: Modern techniques in orthopaedic surgery using minimally invasive procedures, and increased use of fluoroscopic imaging present a potential increased risk to surgeons due to ionizing radiation exposure. This article is a systematic review of recent literature on radiation exposure of orthopaedic surgeons. MATERIALS AND METHODS: Pubmed and Cochrane searches were performed on intraoperative radiation exposure covering English and German articles published between 1.1.2000 and 11.8.2014. Inclusion criteria were clinical studies and systematic literature reviews focusing on radiation exposure of orthopaedic surgeons during surgical procedures of the musculoskeletal system reporting either effective dose (whole body) or equivalent dose at the organ level. All included articles were reviewed with focus on the surgical specialty, the procedure type, the imaging system used, the radiation measurement method, the fluoroscopy time, the radiation exposure, the use of radiation protection, and any references to specific safety guidelines. RESULTS: Thirty-four eligible publications were identified. However, the lack of well-designed studies focusing on radiation exposure of surgeons prevents pooling of data. Highest exposure and subsequent equivalent doses were reported from spinal surgery (up to 4.8mSv of equivalent dose to the hand) and intramedullary nailing (up to 0.142mSV of equivalent dose to the thyroid). Radiation exposure was reduced by 96.9% and 94.2% when wearing a thyroid collar and a lead apron. CONCLUSIONS: With the increasing use of intraoperative imaging, there is a growing need for radiation awareness by the operating surgeon. Strict adherence to radiation protection should be enforced to protect in-training surgeons. Strategies to reduce exposure include C-arm position, distance, protective wear, and new imaging technologies. Radiation exposure is harmful and action should be taken to minimize exposure.

Cross-Cultural Adaptation and Validation of the Lower Extremity Measure Into German.

INTRODUCTION: The Lower Extremity Measure (LEM) was developed to provide a specific instrument to detect changes in physical function in patients with hip fracture. Of 29 questions, 3 have a valid "not applicable" answer option. The goal of this study was to validate the LEM in German and to determine the added value to the physical functioning (pf) subscale of the Short Form 36 (SF-36). MATERIALS AND METHODS: The LEM was translated according to published guidelines and administered to patients with hip fracture (31 A1-A3 and 31 B1-B3) shortly after surgery (baseline), at 3 months (3M), and for reliability testing at 3 months plus 1 week (3M+). The reproducibility, internal consistency, floor and ceiling effects, construct validity, and responsiveness of the German LEM were assessed. RESULTS: A total of 106 patients completed the LEM and SF-36 (mean age 75.5; 67% women) at baseline (mean of 4.9 days after operation), and 88 completed both questionnaires at both the 3M and 3M+ assessments. At each assessment time point, between 6% and 23% of the patients answered 7 questions as "not applicable." Reproducibility and internal consistency were high (intraclass correlation coefficient = 0.93; Cronbach's α = .96). No floor effect (0%) and a minor ceiling effect (7.87%) were found for the total LEM score. The strongest correlation was found between the LEM and the SF-36 subscale pf (Spearman ρ = .93). Responsiveness was similar for the SF-36 pf subscale and the LEM when using effect size (SF-36 pf 0.71 vs LEM 0.72) and better for the LEM when using standardized response mean (SF-36 pf 0.65 vs LEM 0.76). DISCUSSION: The German LEM is a reliable, valid, and responsive measure for the self-assessment of patients after hip fracture surgery. As a number of questions are not applicable to elderly patients, the added value of this lengthy questionnaire in these often frail, sometimes cognitively impaired patients is still open for debate.

Do design adaptations of a trochanteric nail make sense for Asian patients? Results of a multicenter study of the PFNA-II in Japan.

PURPOSE: Asian patients with osteoporosis suffer from an increased incidence of hip fracture and a potentially increased risk of fixation failure due to anatomical differences compared to Caucasians. To cope with these differences, an Asian size- and geometry-adapted Proximal Femoral Nail Antirotation (PFNA-II) was developed. The objective of this prospective multicenter study was to assess the risk of fracture fixation complications (FFCs), the occurrence of mismatch and the quality of life status of patients treated with the PFNA-II. PATIENTS AND METHODS: 176 Japanese patients with an isolated, unstable, closed trochanteric fracture were treated with the PFNA-II. Patients were prospectively screened for anticipated complications and classified accordingly; complications were centrally reviewed by a complication review board to avoid bias by the treating surgeon, and categorized using a standardized reporting system. Outcome measurements included the occurrence and evaluation of FFCs, the radiological assessment of mismatch and quality of life measured with the EQ-5D score. RESULTS: 3 Intraoperative and 15 postoperative complications were found in 16/176 patients. The risk of sustaining any intraoperative or postoperative FFC was 1.7% (3/176; 95% CI: 0.35-4.9) and 8% (14/176; 95% CI: 4.4-13), respectively. The most likely cause for FFCs was the "bone/fracture" factor (9/14 patients). Radiologically detectable contact of the implant with the inner cortex ("mismatch") was reported for 17/173 patients (10%). CONCLUSIONS: The reported complication risks and mismatches are reasonable for this patient cohort. The geometry- and size-adapted PFNA-II is relatively safe but requires standardized assessment in a larger target cohort.