Introduction

Lack of standardization of outcome measurement has hampered an evidence-based approach to clinical practice and research. We report on the progress on establishing a minimal set of core domains for outcome measurement in distal radius fracture.

Introduction

Although a previous hip fracture is one of the strongest predictors for the next one this risk might be modified by other factors. The goal of this analysis was to compute a simple algorithm to assess the individual risk for a contralateral hip fracture.

Background

Second-generation high-carbon CoCrMo-alloy metal-on-metal total hip arthroplasty (THA) was introduced in the late 1980s following reports of early loosening, impingement, pronounced wear, and hypersensitivity in the first-generation metal-on-metal articulations. There has been inconsistent data that specifically addresses the clinical performance and longevity of second-generation metal-on-metal THA. The purpose of this study was to evaluate the survival of second-generation metal-on-metal primary THA and to assess the influence of demographic factors on implant survival in a large patient cohort.

Background: The interpretation of safety data from clinical studies such as complication risks requires clear definition of targeted and documented complication events. In addition a standardized classification of complications is required to allow appropriate comparison of safety data between studies and treatment groups. This presentation highlights a proposal for a standardized management and classification of complication data to initiate and seek consensus among trauma surgeons active in clinical documentation and research.

Methods: Complication events are examined regarding their timing of occurrence as well as their potential causal inter-relationship for any given patient. While independent events are numbered sequentially, directly associated events (e.g. a fracture collapse and implant screw perforation into a joint) receives the same complication number. Complications are described and categorized according to a pre-defined list of anticipated complication types, or as un-anticipated complications. They are further classified as local or general; local complications occur at or directly around the injuries and are further classified as being “Implant/Surgical procedure”, “Bone/Fracture” or “Soft tissue/Wound” events. Information regarding their operative and/or non-operative treatment and their outcome is recorded. Further assessments are made regarding their seriousness, their relation to the implant used. Final classification of complication events is better determined after independent review by a panel of experienced clinicians.

Results: Our classification process was applied successfully to a series of clinical studies at our department. In a study of 185 distal radius fractures treated by LCP, at least one complication occurred in 21 patients, and in seven cases there was a combination of associated events (e.g. one CTS with tendon rupture). Complication risks ranging from 0% to 11.4% were noted depending on which complications and time frames were considered. There was no risk to obtain a LCP implant specific related complication, whereas the risk for a local complication within 6 months after surgery was 6% (95% CI: 3% – 11%).

Conclusions: This management and classification system proved valuable in the documentation and analysis of safety data from clinical studies. It facilitates communication and understanding of definitions between clinicians, as well as allows a prompt, standardised and accurate analysis and reporting of complication events and risks. We encourage other clinical researchers and professionals to participate in the further development and acceptance of a universal classification system for complications in traumatology and orthopaedics.

Background: The nature and frequency of complications during or after orthopaedic interventions represent critical clinical information for safety evaluations, which are required in the development or improvement of medical procedures and devices. However, neither uniform definitions nor established classifications about the reporting of complications exist. So complication reporting, even in orthopaedic trials is still up to the surgeons perception and understanding. The goal of this systematic review was to check whether essential data are consistently provided by the authors in the assessment of incidence, severity and characteristics of complications related to orthopaedic interventions in randomized controlled trials.

Methods: Five major, peer-reviewed orthopaedic journals were screened for published randomized controlled trials (RCTs) 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 in RCTs. The results were stratified for the main area of the trial.

Results: One hundred and twelve RCTs meeting our inclusion criteria were identified. The majority of RCTs (n = 73) reported on surgical treatment methods, with most of the trials focussing on arthroplasty (38%); surgical fracture treatment and other surgical interventions accounted for 13% each. Although complications were included as trial outcomes in two thirds of the studies, clear definitions of anticipated complications were provided at least partly in only two trials of fracture treatment and six other trials. It remained unclear whether authors considered the specific events “death”, “mal-union”, “impaired function” and “re-operation” as complications; “impaired function” was not considered as a complication in 93% of the trials and “re-operation” events were considered in only 50% of the trials dealing with surgical fracture treatments. In 83% of RCTs, the identity of the person or group assessing the complications was unknown and in a further 8%, this process was implemented by the treating surgeon. This review did not identify any trial involving a Data Safety Review Board for assessment and classification of complications.

Conclusions: Due to the lack of homogeneity among the published trials, improvement in the reporting of complications is necessary. A standardized protocol for assessing and reporting complications should be developed and endorsed by professional organizations and most importantly, clinical investigators.

Since the introduction of the first National Arthroplasty Register in Sweden in 1975, many other countries have tried to adopt the successful Scandinavian system. However, not all have overcome the political and practical difficulties of establishing a working register. We have surveyed the current registries to establish the key factors required for an effective database. We have received detailed information from 15 arthroplasty registers worldwide. The legal conditions under which they operate together with the methods of collection and handling of the data differ widely, but the fulfilment of certain criteria is necessary achieve a high degree of completeness of the data to ensure the provision of statistically relevant information.

Background The new concepts of health assessment based on the WHO’s International Classification of Functioning, Disability, and Health (ICF) require the increased use of patient self-rated outcome measurement. There is an extensive body of literature to support the concept that self-rating is far more valid than ‘objective’ parameters such as x-ray findings, range of motion etc. While the value of joint-specific assessment is obvious in rheumatoid arthritis (RA), the need for comprehensive outcome parameters may seem to be less important. We present an exemplary study which compares generic, comprehensive assessment with condition-specific assessment.

Methods In a cross-sectional catamnesis study, the outcomes of patients with RA and posttraumatic (PT) elbows were compared 11 years after total elbow arthroplasty using generic and specific self-rating instruments.

Results Compared to the scores recorded for the 20 PT patients, the 59 RA patients achieved mean scores of 105.6% on the Short Form 36 (SF-36) Mental Component Summary, 82.5% on the Patient Related Elbow Evaluation (PREE) function, 69.5% on the Disability of the Arm, Shoulder and Hand (DASH) function, and 60.2% on the SF-36 physical functioning (a higher score means better health).

Conclusions The elbow-specific PREE revealed little functional deficits for RA compared with PT, the arm-specific DASH showed moderate, and the generic, comprehensive SF-36 demonstrated large functional deficits, whereas psychosocial health was comparable for RA and PT. Post-interventional outcomes may be similar when focusing on a specific condition or joint. Functional deficits and holistic health can only be captured by comprehensive measurement when dealing with systemic polyarticular affection like RA.

Introduction: The restoration of the anatomical centre of rotation can be achieved in total shouder arthroplasty (TSA) using newly developed modular shoulder prosthesis (Promos), anchored with rectangled, non-cemented shaft. Especially patients with complex pathological destructions due to rheumatoid arthritis (RA) should benefit from this feature. So far it was not clear, whether the concept works in their poor bone stock too. The aim of this prospective study was to assess outcome and complication rate of patients with RA and Omarthrosis (OA) after TSA with Promos prosthesis.

Materials and Methods: All patients that received a TSA either due to OA or due to RA were prospectively recorded and evaluated 6 and 12 month after surgery. Functional outcome and quality of life was charged with a standardized scores set (DASH, Constant-Murley score, SPADI, ASES and SF-36, all normalized from 0=worst to 100=best) and compared with normative data as well as with data from a retrospective control, operated with an Aequalis prosthesis. Number and types of complications were recorded and the radiological findings evaluated from an independent observer.

Results: Although RA patients (n=8) did not reach the same functional results than OA patients (n=53) operated with Promos“ prostheses (DASH 78 in OA vs. 67.4 in RA, CS 74.3 in OA vs. 67.6 in RA) the difference between both indication groups was significantly smaller than for the Aequalis prosthesis (p< 0.001). Whereas RA patients after Promos“ prosthesis revealed functional deficits ranging from −6.7 in the Constant score, −10.6 in the DASH to −11.1 in the SPADI, this difference was larger in the Aequalis group with −16.4 in the Constant score, −25.2 in the DASH and −19.6 in the SPADI. Radiological findings and complication rate did not differ significantly.

Discussion: The newly developed modular design of the Promos prosthesis seems to offer better features to restore the complex anatomy, especially in RA patients. The required cementless shaft anchorage is not associated with a higher complication risk. Methodological issues limit the comparison of the two studies and the differences have to be proven in a prospective, comparative study therefore.

Background Critical reflection in clinical routine and research raises the question of how we measure outcome. The classical etiopathogenetic way of thinking has led to biophysical, investigator-based, ‘objective’ parameters. However, new concepts of holistic health assessment based on the WHO’s International Classification of Functioning, Disability, and Health (ICF) emphasize the patient’s (subjective) perception.

Methods We present different approaches to health and health-related quality of life assessment by applying assessment tools to specific examples and providing an overview of some of the existing instruments with an analysis of their properties.

Results Self-assessments reflect the patient’s needs more closely than biophysical parameters. Reliability and validity of the self-assessments are high and population surveys provide valid norms for comparisons. Generic instruments offer a comprehensive range of measurements, and condition-specific self-assessment tools differ in their pattern of health dimensions and their sensitivity to change (responsiveness) as expressed by specific scales. A specific set of instruments has to be compiled appropriate to the focus of interest.

Conclusions Self-assessments are an important complement to clinical signs as indicators of the patient’s condition and fulfill the requirements of the modern salutogenetic, holistic view of the patient as set out in the ICF concept. As a valid representation of the patient’s needs they help in the optimization of disease management and medical-economic planning.

Introduction: Patient self-assessment plays a significant rule in the monitoring of patients within clinical studies as well as a separate quality indicator. The self-assessment of function, disease activity and quality of life is known to have a predictive value in the disease progression of rheumatoid arthritis (RA) and other orthopaedic diseases. However, all questionnaires challenge the clinical infrastructure. The questionnaire administration and their processing require still considerable manpower and is a potential source for errors. We analysed the in-house processes, identified the essential requirements and explored possible electronic solution with the aim to reduce necessary manpower and failure sources.

Materials and methods: In a first step we defined a set of questionnaires we want to administer on a regular base. We then evaluated candidate systems with respect to data handling and to further statistic processing. Two years later we re-evaluated the system and possible alternatives. We then paid special attention to scanning features and data export options. Finally we performed reliability and handling tests and a first clinical trial.

Results: The standardized set for shoulder patients comprises 144 items per patients. The set was designed as a four-color print for automatic processing with Qualicare. Four large studies with a total of more than 300 evaluations were performed using Qualicare. Our reevaluation of the system revealed major problems with the line scanner, the data processing in the system and the data export into statistics programs. After intensive search we installed a new scanning system based on an OMR reader that detects regions of interests on the questionnaire (Remark Office). This system allows simple form generation with the PC, the use of bar-code and faster processing. Reliability was more than 0.95 and handling revealed no major problems. Since first trials were successful the new system became the standard for all questionnaires in our department. Discussion: The high amount of variables in patient self-assessment requires automated processing to save manpower and to avoid failures during manual processing. During a three-year period we identified scanning and export options as the key factors for long-term success. The new system (Remark Office) accomplishes both requirements and might serve as the base for large studies or regular quality control.

Since the successful introduction of National arthroplasty registers by the Scandinavian countries, requirements in arthroplasty research have changed from pure implant survival rates to functional results and quality of life aspects. More patient data are required to address these areas. The goal of our international arthroplasty register survey was to determine key factors for an effective database as source for these scientific analyses.

In the first step, we identified and analysed all available arthroplasty registers via extensive literature and web searches. The preliminary data were validated by sending out a standardized questionnaire with questions regarding goals, organization, funding, documentation, data handling and output of the register. The responses were checked and, if necessary, further information requested via phone.

So far we received detailed information from nine arthroplasty registers worldwide. Only two registers collect data from clinical scores or questionnaires in addition to data for the survival rate. The majority of registers are maintained by the national orthopaedic associations, others like Finland by governmental organizations. The legal boundary conditions vary considerably, e.g. in Finland participation is mandatory, while patient tracking via Social security numbers is not possible in all countries. The rate of participating hospitals ranges up to 100%: 510 surgeons in Canada (72%) – 43 hospitals in Denmark (100%). The preferred locations are hip and knee, the preferred documentation method is paper-based, several registers offer online access or other types of electronic data transfer. In return, surgeons receive a regular feedback from the registers, mostly in form of annual reports. Only a few registers allow the surgeons to have online access to their data in the database. Funding is still of major concern. Although the definition of annual total costs varies, they stay far below 500,000 dollars. Examples of funding sources are the government, National Orthopaedic Associations, grants, a levy placed on the sale of implants, and others.

For the completeness of the collected data, a high rate of participating hospitals as well as a high follow-up-rate is crucial. This can only be guaranteed with substantial funding, governmental support for setting up an adequate framework and the compliance of the participating hospitals. New ways of data collection and processing might help to increase patient and hospital compliance.

Introduction Shoulder prosthesis of the third generation should allow a better restoration of the center of rotation in the replaced humeral head and a better adaptation to anatomical complex situations. Finally this should lead to an improved functional outcome compared with common types of prosthesis. We performed a retrospective study using the far most accepted scores to assess functional outcome and quality of lifer in order to compare our results with the clinical literature.

Materials and Methods 107 patients with a total of 111 prosthesis out of 127 patients were evaluated 3 to 4 years after implantation of a cemented prosthesis of the third generation (Aequalis″< caron> ) combined with a pegged Glenoid. The functional outcome was evaluated with the following scores: DASH, ASES, SPADI and Constant score (CS). Quality of life was rated using short form 36 (SF-36). Further data were recorded using a comorbidity self-assessment, a sociodemographic and a transition questionnaire. Patient data from SF-36, DASH and Constant Score were compared with normative data from age-, sex- and comorbidity corrected control groups. Paired, non-parametric testing was performed with the Wilcoxon-Test and Bonferroni correction. Radiographs were taken in three standard planes and the glenoid was evaluated according to Lazarus et al.

Results The Constant score at the time of follow up reached with 72±16 97% of the norm population. The subscore pain improved in average from 3 to 12 (maximum 15) and the subscore mobility from 14 to 32 (maximum 40).

Patients with primary arthrosis (n=44) and patients with posttraumatic arthrosis (n=39) had no functional deficits compared to the normal population in contrast to patients with RA (n=17). They showed significantly functional deficits (p< 0.001) in the DASH score as well as in the physical sum scale of the SF-36 (p=0.008). The majority of glenoids showed an incomplete lyses around one dowel (grade I in 70%). Less than 2% showed grade III or IV.

Discussion Implantation of a shoulder prosthesis of the third generation leads to good functional results compared with the control population. Functional and physical deficits remain in patients with an underlying RA. Glenoid loosening seems to be of minor concern. Our results prove the good clinical results that are reported in the literature, however they have to be proven with a longer follow-up.

The treatment of fractures of the proximal tibia is complex and makes great demands on the implants used. Our study aimed to identify what levels of primary stability could be achieved with various forms of osteosynthesis in the treatment of diaphyseal fractures of the proximal tibia. Pairs of human tibiae were investigated. An unstable fracture was simulated by creating a defect at the metaphyseal-diaphyseal junction. Six implants were tested in a uniaxial testing device (Instron) using the quasi-static and displacement-controlled modes and the force-displacement curve was recorded. The movements of each fragment and of the implant were recorded video-optically (MacReflex, Qualysis). Axial deviations were evaluated at 300 N.

The results show that the nailing systems tolerated the highest forces. The lowest axial deviations in varus and valgus were also found for the nailing systems; the highest axial deviations were recorded for the buttress plate and the less invasive stabilising system (LISS). In terms of rotational displacement the LISS was better than the buttress plate.

In summary, it was found that higher loads were better tolerated by centrally placed load carriers than by eccentrically placed ones. In the case of the latter, it appears advantageous to use additive procedures for medial buttressing in the early phase.

Aims: The holding power of new designed implants, need to be improved by osseointegration, in particular in osteoporotic bone. The osseo-integration depends on the interface mechanical conditions during fracture healing or fusion leading either to bony incorporation or to micro-movement and encapsulation. The aim of the current study was to evaluate the load sharing conditions after the fusion process between implant and bone with respect to the fusion status of the stabilized segment. Methods: The hollow cylinder based implant was used to stabilize a corpectomy of L4 in 17 sheep (9 osteoporotic and 8 control). After a survival time of 4 month the spine specimens were tested in a six-degree-of-freedom (6DOF) device in the three principal directions (flex/ex, lat. bending, torsion). Hysteresis curves were recorded before and after removal of the stabilizing longitudinal bar. The changes in ROM and stiffness in the different planes were compared statistically (α < 0.05). The results were validated histologically. Results: The increase in range of motion in all planes was significantly higher after implant removal in animals that were classified as non-fused spines (+35±15% in non-fused vs. +12±8% in fused spines). At the same time stiffness decreased significantly more (stiffness ex/flex −31±14% in non-fused vs −7±7% in fused spines) without differnces between normal and osteoporotic spines. Histology revealed 3 capsules in the fused spines. Conclusions: If fusion takes place in the presence of a relatively stiff implant the load flow through the implant is interrupted by connective tissue on one of the implant/bone interfaces. The changes in ROM and stiffness indicate the remaining contribution of the implant to the load sharing of the implant/ bone complex in case of non-fusion and are highly sensitive therefore to predict micromovement.