Evidence-based and Patient-centered Indication for Knee Arthroplasty - Update of the Guideline. / Evidenzbasierte und patientenorientierte Indikationsstellung zur Knieendoprothese ­ Update der Leitlinie.

Knee arthroplasty is one of the most frequently performed operations in Germany, with approximately 170000 procedures per year. It is therefore essential that physicians should adhere to an appropriate, and patient-centered indication process. The updated guideline indication criteria for knee arthroplasty (EKIT-Knee) contain recommendations, which are based on current evidence and agreed upon by a broad consensus panel. For practical use, the checklist has also been updated.For this guideline update, a systematic literature research was conducted in order to analyse (inter-)national guidelines and systematic reviews focusing on osteoarthritis of the knee and knee arthroplasty, to answer clinically relevant questions on diagnostic, predictors of outcome, risk factors and contraindications.Knee arthroplasty should solely be performed in patients with radiologically proven moderate or severe osteoarthritis of the knee (Kellgren-Lawrence grade 3 or 4), after previous non-surgical treatment for at least three months, in patients with high subjective burden with regard to knee-related complaints and after exclusion of possible contraindications (infection, comorbidities, BMI ≥ 40 kg/m2). Modifiable risk factors (such as smoking, diabetes mellitus, anaemia) should be addressed and optimised in advance. After meeting current guideline indications, a shared decision-making process between patients and surgeons is recommended, in order to maintain high quality surgical management of patients with osteoarthritis of the knee.The update of the S2k-guideline was expanded to include unicondylar knee arthroplasty, the preoperative optimisation of modifiable risk factors was added and the main indication criteria were specified.

[Interpretation of systematic review articles and meta-analyses : Clinical trials in trauma surgery and orthopedics]. / Interpretation von systematischen Übersichtsarbeiten und Metaanalysen : Klinische Studien in Unfallchirurgie und Orthopädie.

Clinical trials must be planned and interpreted in the context of current best clinical and scientific evidence, undoubtedly provided by systematic reviews and meta-analyses, especially Cochrane Reviews. While many clinicians feel overwhelmed by this complex data source, few visualElements (e.g., the traffic light system of the Cochrane risk of bias [RoB­2] tool, forest plots, etc.), together with indices such as the I2 heterogeneity statistic, allow for a quick appraisal of all critical and necessary qualitative and quantitative information. The effectiveness of different treatment options can indirectly be assessed by methodological advancements like network meta-analyses.Point estimates of percentages are insufficient to describe the utility and value of a proposed novel intervention, which, in orthopedic and trauma surgery, often represents a step innovation. 95% confidence intervals and the so-called fragility index are helpful in determining the ultimate patient benefit.

Intraoperative analysis of patellofemoral joint morphology before and after total knee arthroplasty : A feasibility study.

BACKGROUND: Patellofemoral problems after total knee arthroplast (TKA) are frequent and often associated with a change in the geometry of the trochlear groove. OBJECTIVE: The present study aimed to analyze the feasibility of intraoperative examination of the patellofemoral joint geometry before and after the implantation of bicondylar total knee replacements without exposing the patient to radiation. MATERIAL AND METHODS: The patellofemoral joint morphology geometries of 33 patients before and after implantation of a bicondylar total knee replacement was intraoperatively analyzed using a digital scanning method. Femoral surface geometries were extracted from intraoperatively recorded tactile scanning data using an in-house algorithm. The geometries were then characterized by sulcus height, medial femoral condyle height and lateral femoral condyle height. RESULTS: Our preliminary results show that these key geometric parameters are only partially restored after TKA leading to a distinctly different shaped profile of the anterior distal femur. Maximum and minimum mean differences in sulcus height, medial femoral condyle height, and lateral femoral condyle height before and after surgery were 2.00 mm/-3.06 mm, 2.51 mm/-6.25 mm and 2.74 mm/-3.58 mm, respectively. CONCLUSION: A new method for intraoperative analysis of the patellofemoral joint morphology before and after TKA without radiation exposure was developed and utilized. Even with the use of modern total knee designs, the patellofemoral articulation is considerably changed postoperatively as quantified by the key parameters of sulcus height, medial femoral condyle height, and lateral femoral condyle height. This may result in altered knee biomechanics and might explain persistent patellofemoral disorders, which are often reported by patients after TKA.

The impact of illness perception on functionality, pain, stiffness, and activity of daily living after total hip replacement surgery.

OBJECTIVE: According to the Common Sense Model (CSM), cognitive and emotional representations influence recovery. We used groups of individuals grouping multiple cognitive representations (schemas) to predict the recovery process after total hip arthroplasty (THR). METHODS: The aim of this prospective cohort study with three collection time points was to examine the significance of these schemas for functionality three and six months after THR. We assessed illness perception with the Illness Perception Questionnaire-Revised and the functionality with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Data were collected four weeks before (n = 317), three (n = 268), and six months after (n = 292) primary THR. Groups of individuals with the same schemas were identified using a two-step cluster analysis across cognitive representations. Controlling for WOMAC variables (functionality, stiffness, pain, and activities of daily living) before THR, we calculated the regression of schemas and emotional representations before THR on WOMAC variables after THR. RESULTS: Before THR, two cognitive schemes were found: Schema One: medium identity, long duration, many consequences, low personal and treatment control, and low coherence; Schema Two: low identity, short timeline, low consequences, and high personal and treatment control. Patients with Schema Two had better functionality and lower pain and stiffness three months after surgery compared to those with Schema One. After three months, the influence of cognitive schemas was stronger on functionality than that of emotional representation (f2: 0.04 /0.02). CONCLUSION: Further study is needed to determine whether a psychological intervention can change Schema One.

[Clinical studies in trauma surgery and orthopedics: read, interpret and implement]. / Klinische Studien in Unfallchirurgie und Orthopädie: lesen, interpretieren und umsetzen.

Informative, participatory clinical decision-making needs to combine both skills and expertise as well as current scientific evidence. The flood of digital information makes it difficult in everyday clinical practice to keep up to date with the latest publications. This article provides assistance for coping with this problem. A basic understanding of prior and posterior probabilities as well as systematic error (bias) makes it easier to weigh up the benefits and risks, e.g. of a (surgical) intervention compared to a nonsurgical treatment. Randomized controlled trials (RCT, with all modern modifications) deliver undistorted results but in orthopedic and trauma surgery can lead to a heavily selected nonrepresentative sample and the results must be confirmed or refuted by further, independent RCTs. Large-scale observational data (e.g. from registries) can be modelled in a quasi-experimental manner and accompany RCTs in health technology assessment.

Similar outcomes in computer-assisted and conventional total knee arthroplasty: ten-year results of a prospective randomized study.

BACKGROUND: Computer-assisted navigation (CAS) was developed to improve the surgical accuracy and precision. Many studies demonstrated better alignment in the coronal plane in CAS TKA compared to conventional technique. The influence on the functional outcome is still unclear. Only few studies report long-term results of CAS TKA. This study was initiated to investigate 10-year patient-reported outcome of CAS and conventional TKA. METHODS: From initially 80 patients of a randomized study of CAS and conventional TKA a total of 50 patients could be evaluated at the 10-year follow-up. The Knee Society Score and EuroQuol Questionnaire were assessed. For all patients a competing risk analysis for revision was performed. RESULTS: The patient-reported outcome measures demonstrated similar values for both groups. The 10-year risk for revision was 2.5% for conventional TKA and 7.5% for CAS TKA (p=0.237). CONCLUSIONS: There was no difference between CAS and conventional TKA with regard to patient-reported outcome and revision risk ten years after surgery. TRIAL REGISTRATION: This study was registered at clinicaltrials.gov on 11/30/2009, ID: NCT01022099 .

Fulfillment of expectations influence patient satisfaction 5 years after total knee arthroplasty.

PURPOSE: Constant efforts have been made to improve prosthesis design in total knee arthroplasty (TKA), but a significant number of patients remain dissatisfied postoperatively. Besides poor improvement in pain or function, poor fulfillment of patients expectations were identified as contributing factors. Purpose of the study was to assess fulfillment of patients' expectations and satisfaction with TKA 5 years after surgery. METHODS: A total of 103 patients from a prospective randomised study of a high-flexion or standard TKA implant were investigated 5 years after surgery and patient-reported outcomes (PRO), fulfillment of expectations and satisfaction with the result of the surgery were obtained. RESULTS: There were no differences in PROs, fulfillment of expectations and satisfaction between both implant designs. In total, the patients had high expectations preoperatively, mainly related to pain relief and functional abilities. A total of 89.4% of these expectations were fulfilled. No re-interventions (p < 0.001) and male gender (p = 0.017) were the most important predictors of higher fulfillment of expectations. Satisfaction scored highly at 8.2 out of 10 and most patients (93.2%) would undergo the surgery again. Higher Knee Score (p = 0.012) and fulfillment of expectations (p = 0.002) were correlated with higher satisfaction. CONCLUSION: Five years after surgery fulfillment of expectations and satisfaction were high regardless of implant design and did significantly influence patient satisfaction. Surgeons should be aware of the importance of patients' expectations and their influence on satisfaction after TKA. Therefore, the probability of fulfillment should be discussed during shared decision making for TKA. LEVEL OF EVIDENCE: I.

Microarray analysis for delineating the gene expression in biopsies of gastrocnemius muscle of patients with chronic critical limb ischaemia compared with non-ischaemic controls.

BACKGROUND: Microarray analysis has been carried out in this pilot study to compare delineated gene expression profiles in the biopsies of skeletal muscle taken from patients with chronic critical limb ischaemia (CLI) and non-ischaemic control subjects. PATIENTS AND METHODS: Biopsy of gastrocnemius muscle was obtained from six patients with unreconstructed CLI referred for surgical major amputation. As control, biopsies of six patients undergoing elective knee arthroplasty without evidence of peripheral arterial occlusive disease were taken. The differences in gene expression associated with angiogenic processes in specimens obtained from ischaemic and non-ischaemic skeletal muscle were confirmed by quantitative real-time polymerase chain reaction (PCR) analysis. RESULTS: Compared with non-ischaemic skeletal muscle biopsy of chronic-ischaemic skeletal muscle contained 55 significantly up-regulated and 45 down-regulated genes, out of which 64 genes had a known genetic product. Tissue samples of ischaemic muscle were characterized by increased expression of cell survival factors (e. g. tissue factor pathway inhibitor 2) in combination with reduced expression of cell proliferation effectors (e. g. microfibrillar-associated protein 5 and transferrin receptor). The expression of growth factors (e. g. early growth response 3 and chemokine receptor chemokine C-X-C motif ligand 4) which play a central role in arterial and angiogenic processes and anti-angiogenetic factors (e. g. pentraxin 3) were increased in chronic ischaemic skeletal muscle. An increased expression of extracellular matrix proteins (e. g. cysteine-rich angiogenic inducer 61) was also observed. CONCLUSIONS: Gene expression profiles in biopsies of gastrocnemius muscle in patients with chronic critical limb ischaemia showed an increase in pro-survival factors, extracellular matrix protein deposition, and impaired proliferation, compared with non-ischaemic controls. Further studies are required to analyse the endogenous repair mechanism.

Indication Criteria for Total Knee Arthroplasty in Patients with Osteoarthritis - A Multi-perspective Consensus Study.

Background and Objectives Knee osteoarthritis (OA) is a significant public health burden. Rates of total knee arthroplasty (TKA) in OA vary substantially between geographical regions, most likely due to the lack of standardised indication criteria. We set out to define indication criteria for the German healthcare system for TKA in patients with knee OA, on the basis of best evidence and transparent multi-stakeholder consensus. Methods We undertook a complex mixed methods study, including an iterative process of systematic appraisal of existing evidence, Delphi consensus methods and stakeholder conferences. We established a consensus panel representing key German national societies of healthcare providers (orthopaedic surgeons, rheumatologists, pain physicians, psychologists, physiotherapists), payers, and patient representatives. A priori defined consensus criteria were at least 70% agreement and less than 20% disagreement among the consensus panel. Agreement was sought for (1) core indication criteria defined as criteria that must be met to consider TKA in a normal patient with knee OA, (2) additional (not obligatory) indication criteria, (3) absolute contraindication criteria that generally prohibit TKA, and (4) risk factors that do not prohibit TKA, but usually do not lead to a recommendation for TKA. Results The following 5 core indication criteria were agreed within the panel: 1. intermittent (several times per week) or constant knee pain for at least 3 - 6 months; 2. radiological confirmation of structural knee damage (osteoarthritis, osteonecrosis); 3. inadequate response to conservative treatment, including pharmacological and non-pharmacological treatment for at least 3 - 6 months; 4. adverse impact of knee disease on patient's quality of life for at least 3 - 6 months; 5. patient-reported suffering/impairment due to knee disease. Additional indication criteria, contraindication criteria, and risk factors for adverse outcome were also agreed by a large majority within the multi-perspective stakeholder panel. Conclusion The defined indication criteria constitute a prerequisite for appropriate provision of TKA in patients with knee OA in Germany. In eligible patients, shared-decision making should eventually determine if TKA is performed or not. The next important steps are the implementation of the defined indication criteria, and the prospective investigation of predictors of success or failure of TKA in the context of routine care provision in Germany.

No difference in range of motion between ultracongruent and posterior stabilized design in total knee arthroplasty: a randomized controlled trial.

PURPOSE: The use of an ultracongruent (UC) insert with a standard femoral component for substitution of the posterior cruciate ligament (PCL) is a bone-preserving and therefore interesting alternative to the established box and cam mechanism of posterior stabilized (PS) total knee arthroplasty (TKA). This study investigated range of motion (ROM), stability and patient-reported outcome (PRO) in UC and PS TKA. We hypothesized better knee flexion with the PS design but no difference in stability and PRO between UC and PS TKA. METHODS: A randomized controlled study was performed. One hundred and twenty-seven patients were included, 63 with an UC and 64 with a PS TKA (Columbus, Aesculap, Tuttlingen, Germany). Intraoperative stability and range of motion was measured with the use of a navigation system. Patients were assessed before surgery, 3 months and 1 year postoperatively. RESULTS: There was no difference in ROM between both groups, neither intraoperatively nor at follow-up. There was 5 mm less sagittal translation at 90° of knee flexion (p < 0.001) and more posterior femoral rollback during knee flexion in the PS TKA. Axial rotation between extension and knee flexion was reduced by both designs. UC TKA was 7 min faster (p = 0.001). At the one-year follow-up, the Knee Society Score was similar in both groups, the Oxford Knee Score demonstrated better results in the UC TKA group (p = 0.048). CONCLUSION: Increased intraoperative sagittal translation and reduced posterior femoral rollback during knee flexion of UC TKA seem to have no negative influence on short-term clinical outcome. Therefore, UC TKA seems to be a practical alternative to the established PS TKA for substitution of the PCL. This might be especially interesting for surgeons who do not always substitute the PCL. LEVEL OF EVIDENCE: I.

Patient-reported outcomes and outcome predictors after primary total hip arthroplasty: results from the Dresden Hip Surgery Registry.

PURPOSE: To investigate response rates and predictors of treatment success in patients treated with total hip arthroplasty (THA). METHODS: A prospective register-based cohort study including all consecutive primary THAs was conducted -between 01/2006-12/2011. Primary outcomes were changes in WOMAC, according to OMERACT-OARSI, and minimal important difference (MID) in quality of life (EQ-5D) between baseline and 6-month follow-up. Socioeconomic and clinical predictors on treatment success were analysed by bivariate/multivariate regression. RESULTS: The study population included 2,553 patients (mean age 60.8 years; 52.8% female) and 2,391 (93.7%) at follow-up. 2,194 (93.8%) (OMERACT-OARSI) and 2,131 (83.5%) (EQ-5D MID) patients were classified as responders. Predictors for treatment success vs treatment failure were not identified. Obese patients and patients living alone showed less pronounced, and patients with higher educational level more pronounced, improvements in the WOMAC at follow-up. CONCLUSIONS: Treatment with THA leads to improvement in function, decline in pain and increase in quality of life in the vast majority of patients.

The influence of optimism on functionality after total hip replacement surgery.

Among other factors, optimism has been shown to significantly influence the course of some diseases (cancer, HIV, coronary heart disease). This study investigated whether optimism of a patient before a total hip replacement can predict the functionality of the lower limbs 3 and 6 months after surgery. A total of 325 patients took part in the study (age: 58.7 years; w: 55%). The functionality was measured with the Western Ontario and McMaster Universities arthrosis index, and optimism with the Life Orientation Test. To analyse the influences of age, gender and optimism, general linear models were calculated. In optimistic patients, functionality improved significantly over time. The study showed a clear influence of dispositional optimism on the recovery after total hip replacement in the first 3 months after surgery.

Effect of surgical experience on imageless computer-assisted femoral component positioning in hip resurfacing--a preclinical study.

BACKGROUND: The clinical outcome of hip resurfacing (HR) as a demanding surgical technique associated with a substantial learning curve depends on the position of the femoral component. The aim of the study was to investigate the effects of the level of surgical experience on computer-assisted imageless navigation concerning precision of femoral component positioning, notching, and oversizing rate, as well as operative time. METHODS: Three surgeons with different levels of experience in both HR and computer-assisted surgery (CAS) prepared the femoral heads of 54 synthetic femurs using the Durom(TM) Hip Resurfacing (Zimmer, Warsaw, IN, USA) system. Each surgeon prepared a total of 18 proximal femurs using the Navitrack® system (ORTHOsoft Inc., Montreal, Canada) or the conventional free-hand Durom(TM) K-wire positioning jig. The differences between planned and postoperative stem shaft angle (SSA) and anteversion angle in standardized x-rays were measured and the operative time, not including the time for calibrating the CAS-system, was documented. Notching was evaluated by the three surgeons in a randomized manner. Oversizing was determined by the difference of the preoperative determined cap and the cap size advised by the CAS-system. RESULTS: CAS significantly reduced the overall mean deviation between planned and postoperative SSA in comparison with the conventional procedure (mean ± SD, 1 ± 1.7° vs. 7.4 ± 4.4°, P < 0.01) regardless of the surgeon's level of experience. The incidence of either varus or valgus SSA deviations exceeding 5° were 1/27 for CAS and 15/27 for the conventional method, respectively (P < 0.001), corresponding to a reduction by 97%. Using CAS, the rate of notching was reduced by 100%. CONCLUSIONS: The accuracy of femoral HR component orientation is significantly increased by use of CAS regardless of the surgeon's level of experience in our preclinical study. Thus, imageless computer-assisted navigation can be a valuable tool to improve implant positioning in HR for surgeons at any stage of their learning curve.

Agreement between radiological and computer navigation measurement of lower limb alignment.

PURPOSE: Accurate and reproducible measurements of limb alignment are necessary for planning, performing and evaluation of reconstructive knee surgery. Aim of this study was the comparison of the alignment measured on long-leg standing radiographs with the intraoperative data from a navigation system. METHODS: The records of 135 consecutive patients who received computer-assisted TKA were examined. Technical quality of the long-leg radiographs (LLRs) was classified good, acceptable or poor according to the rotation of the leg. The difference between radiographic and navigation measurements of leg alignment was assessed. RESULTS: Preoperative LLRs were rated as good 56.3% (71.1% postoperatively), acceptable in 37.0% (20.0% postoperatively) and poor in 6.7% (8.9% postoperatively). The median difference between radiographic and navigation measurements increased with reduced quality of the LLR [good 1.5° (range 0.0°-9.9°), acceptable 2.5° (range 0.0°-15.0°), poor 4.5° (range 0.2°-9.5°)], but not with greater deformity. Median difference between both measurements in good radiographs was 1.7° (range 0.0°-9.9°) preoperatively and 1.2° (range 0.0°-7.0°) postoperatively. CONCLUSION: Difference between radiographic and navigation measurements of lower limb alignment is low if the LLR are obtained in neutral rotation. Larger differences between both measurements can occur even under these ideal conditions, and it is still unclear which measurement is closer to reality. Therefore, even if a navigation system is used during surgery, long-leg standing radiographs should currently not be abandoned. LEVEL OF EVIDENCE: III.

No difference between computer-assisted and conventional total knee arthroplasty: five-year results of a prospective randomised study.

PURPOSE: The use of computer-assisted surgery (CAS) in total knee arthroplasty (TKA) results in better limb and implant alignment compared to conventional TKA; however, it is unclear whether this translates to better mid- to long-term clinical outcome. This prospective randomised study comparing CAS and conventional TKA reports the functional and patient perceived outcomes at a follow-up of 5 years. The hypothesis was that there would be a difference in functional outcome or quality of life after mid-term follow-up. METHODS: Sixty-seven patients were available for physical and radiological examination at 5 years. The Knee Society Score (KSS) was used to describe functional outcome and the Euroquol questionnaire for quality of life. RESULTS: The mean total KSS for the CAS group improved from 91.1 (SD 22.3) points preoperatively to 157.4 (SD 21.9) and 150.2 (SD 30.4) points at 2 and 5 years, respectively. In the conventional group, the mean total KSS was 99.6 (SD 18.6) points preoperatively and 151.1 (SD 26.0) and 149.0 (SD 28.0) points at 2 and 5 years, respectively. The mean quality of life score improved from 48.2 (SD 16.5) points preoperatively to 67.4 (SD 16.3) and 66.8 (SD 22.2) points at 2 and 5 years in the CAS group, and from 52.2 (SD 17.1) points preoperatively to 65.6 (SD 14.6) and 61.7 (SD 19.3) points at 2 and 5 years, respectively, in the conventional TKA group. These differences were not statistically significant. There were radiolucent lines up to 2 mm in 11 knees (four CAS, seven conventional), but there were no changes in implant position. CONCLUSIONS: There were no significant differences in functional or patient perceived outcome after mid-term follow-up in this study. LEVEL OF EVIDENCE: I.

[Clinical trials investigating the therapeutic benefit of medical devices in orthopaedics and trauma surgery: practice examples plus commentary]. / Studien zum therapeutischen Nutzen von Medizinprodukten in O+U: Kommentierte Praxisbeispiele.

Patients recognise relevant symptoms of the two leading diseases in orthopaedics and trauma surgery: osteoarthritis and fractures. Treatment effects can be demonstrated by patient reported outcomes. Total hip arthroplasty as an example for standard treatment regimen achieves large treatment effects. It is hard to demonstrate an additional benefit against standard treatment while observing ceiling effects. Alternative instruments are needed. Navigated total knee arthroplasty is done for better control of the postoperative axis as well as to reduce the revision burden. The time interval needed to demonstrate the decrease in revision has not yet passed. Additional benefits of total knee navigation have been observed for certain patient populations and for the training of physicians. These benefits have not been investigated so far. Using registries, expert opinions and case series the desired benefit from the use of medical devices can be shown. Safety is one major aspect of innovative medical devices as an additional benefit. The safety paradigm needs intense investigation in the future. The IDEAL Statement provides the clinical researcher with the methodological framework. The METEOR Statement focused on the medical problem and the possible benefit with using innovative medical devices. Within these recommendations a broad number of study types can be employed to demonstrate the benefits for patients.

Do survival rate and serum ion concentrations 10 years after metal-on-metal hip resurfacing provide evidence for continued use?

BACKGROUND: Owing to concerns attributable to problems associated with metal-on-metal bearing surfaces, current evidence for the use of hip resurfacing is unclear. Survival rates reported from registries and individual studies are controversial and the limited long-term studies do not conclusively allow one to judge whether hip resurfacing is still a reasonable alternative to conventional THA. QUESTIONS/PURPOSES: We asked whether the long-term survival rate of hip resurfacing is comparable to that of conventional THA and certain factors can be identified that influence serum ion concentration 10 years postoperatively. We specifically assessed (1) the 10-year survivorship in the whole cohort and in male and female patients, (2) serum concentrations of metal ions in patients with hip resurfacing who had not undergone revision surgery, and (3) potential influencing factors on the serum ion concentration. METHODS: We retrospectively reviewed our first 95 patients who had 100 hip resurfacings performed from 1998 to 2001. The median age of the patients at surgery was 52 years (range, 28-69 years); 49% were men. We assessed the survival rate (revision for any reason as the end point), radiographic changes, and serum ion concentrations for cobalt, chromium, and molybdenum. The correlations between serum ion concentration and patient-related factors (age, sex, BMI, activity) and implant-related factors (implant size, cup inclination, stem-shaft angle) were investigated. The minimum followup was 9.3 years (mean, 10 years; range, 9.3-10.5 years). RESULTS: The 10-year survivorship was 88% for the total cohort. The overall survival rate was greater in men (93%) than in women (84%). Median serum ion levels were 1.9 µg/L for chromium, 1.3 µg/L for cobalt, and 1.6 µg/L for molybdenum. Radiolucent lines around acetabular implants were observed in 4% and femoral neck thinning in 5%. CONCLUSIONS: Although our overall failure rate was greater than anticipated, the relatively low serum ion levels and no revisions for pseudotumors in young male patients up to 10 years postoperatively provide some evidence of the suitability of hip resurfacing in this subgroup. LEVEL OF EVIDENCE: Level IV, therapeutic study. See the Instructions for Authors for a complete description of levels of evidence.

Cost effectiveness of total knee arthroplasty from a health care providers' perspective before and after introduction of an interdisciplinary clinical pathway--is investment always improvement?

BACKGROUND: Total knee arthroplasty (TKA) is an effective, but also cost-intensive health care intervention for end stage osteoarthritis. This investigation was designed to evaluate the cost-effectiveness of TKA before versus after introduction of an interdisciplinary clinical pathway from a University Orthopedic Surgery Department's cost perspective as an interdisciplinary full service health care provider. METHODS: A prospective trial recruited two sequential cohorts of 132 and 128 consecutive patients, who were interviewed by means of the WOMAC questionnaire. Direct process costs from the health care providers' perspective were estimated according to the German DRG calculation framework. The health economic evaluation was based on margiual cost-effectveness ratios (MCERs); an individual marginal cost effectiveness relation≤100 € per % WOMAC index increase was considered as primary endpoint of the confirmatory cohort comparison. The interdisciplinary clinical pathway under consideration primarily consisted of a voluntary preoperative personal briefing of patients concerning postoperatively expectable progess in health status and optimum use of walking aids after surgery. All patients were supplied with written information on these topics, attendance of the personal briefing also included preoperative training for postoperative mobilisation by the Department's physiotherapeutic staff. RESULTS: An individual marginal cost effectiveness relation≤100 €/% WOMAC index increase was found in 38% of the patients in the pre pathway implementation cohort versus in 30% of the post pathway implementation cohort (Fisher p=0.278). Both cohorts showed substantial improvement in WOMAC scores (39 versus 35% in median), whereas the cohort did not differ significantly in the median WOMAC score before surgery (41% for the pre pathway cohort versus 44% for the post pathway cohort). Despite a locally significant decrease in costs (4303 versus 4194 € in median), the individual cost/benefit relation became worse after introduction of the pathway: for the first cohort the MCER was estimated 108 € per gained % WOMAC index increase (86-150 €/%) versus 118 €/% WOMAC gain (93-173 €/%) in the second cohort after pathway implementation. In summary, the proposed critical pathway for TKA could be shown to be significantly cost efficient, but not cost effective concerning functional outcome, when the above individual marginal cost effectiveness criterion was concentrated on. CONCLUSIONS: The introduction of an interdisciplinary clinical pathway does not necessarily improve patient related outcomes. On the contrary, cost effectiveness from the health care providers' perspective may even turn out remarkably reduced in the setting considered here (functional outcome assessment after treatment by a full service health care provider).

Adverse events in total knee arthroplasty: Results of a physician independent survey in 260 patients.

PURPOSE: Identification of all common and potentially avoidable adverse events is crucial to further improve the quality of medical care. The intention of the current study was to evaluate a standardized physician independent survey format on adverse events in total knee arthroplasty. The protocol for reporting adverse drug events following the International Conference of Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) was adopted for adverse events occurring during surgical interventions. MATERIAL AND METHODS: Data of a prospective sequential cohort trial introducing a clinical pathway for total knee arthroplasty was analysed. Reporting of adverse events was done by a physician independent study nurse using the modified ICH-Good Clinical Practice (GCP) format (Structure and Content of Clinical study reports - E3) in 260 patients. The adverse events were graded to their severity and their potential relation to surgical treatment. RESULTS: A total of 55 patients (21%) suffered from an adverse event and 16 (6%) from a serious adverse event. In 38 patients' one adverse event occurred, 12 patients showed 2 adverse events and 5 patients suffered from a combination of an adverse and a serious adverse event. A serious adverse event alone occurred in 11 patients. The incidence of adverse events (Fisher p = 0.448) and serious adverse (p = 0.126) events showed no significant difference between the two cohorts. The most common adverse events were deep vein thrombosis (8% and 5%) followed by wound healing problems (1% and 0%) and haematoma (1% and 3%). A wide range of non surgical adverse events were recorded with low incidence levels. CONCLUSION: The use of the modified ICH-GCP format supports standardization of adverse event reporting. Routine assessment of adverse events by a study nurse revealed higher incidence rates of adverse events in total knee arthroplasty. We recommend the implementation of trained paramedical staff for the documentation of adverse events in routine clinical care.