Person:

Malchau, Henrik

Background: There is currently a paucity of devices available for continuous, long-term monitoring of human joint motion. Non-invasive, inexpensive devices capable of recording human activity and joint motion have many applications for medical research. Such a device could be used to quantify range of motion outside the gait laboratory. The purpose of this study was to test the accuracy of the modified Intelligent Device for Energy Expenditure and Activity (IDEEA) in measuring knee flexion angles, to detect different physical activities, and to quantify how often healthy subjects use deep knee flexion in the ambulatory setting. Methods: We compared Biomotion Laboratory (BML) "gold standard" data to simultaneous IDEEA measures of knee motion and gait, step up/down, and stair descent in 5 healthy subjects. In addition, we used a series of choreographed physical activities outside the BML to confirm the IDEEA's ability to accurately measure 7 commonly-performed physical activities. Subjects then continued data collection during ordinary activities outside the gait laboratory. Results: Pooled correlations between the BML and IDEEA knee flexion angles were .97 +/- .03 for step up/down, .98 +/- .02 for stair descent, and .98 +/- .01 for gait. In the BML protocol, the IDEEA accurately identified gait, but was less accurate in identifying step up/down and stair descent. During sampling outside the BML, the IDEEA accurately detected walking, running, stair ascent, stair descent, standing, lying, and sitting. On average, subjects flexed their knees >120° for 0.17% of their data collection periods outside the BML. Conclusion: The modified IDEEA system is a useful clinical tool for evaluating knee motion and multiple physical activities in the ambulatory setting. These five healthy subjects rarely flexed their knees >120°.

Background and purpose Guidelines for standardization of radiostereometry (RSA) of implants were published in 2005 to facilitate comparison of outcomes between various research groups. In this systematic review, we determined how well studies have adhered to these guidelines. Methods: We carried out a literature search to identify all articles published between January 2000 and December 2011 that used RSA in the evaluation of hip or knee prosthesis migration. 2 investigators independently evaluated each of the studies for adherence to the 13 individual guideline items. Since some of the 13 points included more than 1 criterion, studies were assessed on whether each point was fully met, partially met, or not met. Results: 153 studies that met our inclusion criteria were identified. 61 of these were published before the guidelines were introduced (2000–2005) and 92 after the guidelines were introduced (2006–2011). The methodological quality of RSA studies clearly improved from 2000 to 2011. None of the studies fully met all 13 guidelines. Nearly half (43) of the studies published after the guidelines demonstrated a high methodological quality and adhered at least partially to 10 of the 13 guidelines, whereas less than one-fifth (11) of the studies published before the guidelines had the same methodological quality. Commonly unaddressed guideline items were related to imaging methodology, determination of precision from double examinations, and also mean error of rigid-body fitting and condition number cutoff levels. Interpretation The guidelines have improved methodological reporting in RSA studies, but adherence to these guidelines is still relatively low. There is a need to update and clarify the guidelines for clinical hip and knee arthroplasty RSA studies.

Objective: To define a minimum Standard Set of outcome measures and case‐mix factors for monitoring, comparing, and improving health care for patients with clinically diagnosed hip or knee osteoarthritis (OA), with a focus on defining the outcomes that matter most to patients. Methods: An international working group of patients, arthroplasty register experts, orthopedic surgeons, primary care physicians, rheumatologists, and physiotherapists representing 10 countries was assembled to review existing literature and practices for assessing outcomes of pharmacologic and nonpharmacologic OA therapies, including surgery. A series of 8 teleconferences, incorporating a modified Delphi process, were held to reach consensus. Results: The working group reached consensus on a concise set of outcome measures to evaluate patients’ joint pain, physical functioning, health‐related quality of life, work status, mortality, reoperations, readmissions, and overall satisfaction with treatment result. To support analysis of these outcome measures, pertinent baseline characteristics and risk factor metrics were defined. Annual outcome measurement is recommended for all patients. Conclusion: We have defined a Standard Set of outcome measures for monitoring the care of people with clinically diagnosed hip or knee OA that is appropriate for use across all treatment and care settings. We believe this Standard Set provides meaningful, comparable, and easy to interpret measures ready to implement in clinics and/or registries globally. We view this set as an initial step that, when combined with cost data, will facilitate value‐based health care improvements in the treatment of hip and knee OA.

Background and purpose An earlier Nordic Arthroplasty Register Association (NARA) report on 280,201 total hip replacements (THRs) based on data from 1995–2006, from Sweden, Norway, and Denmark, was published in 2009. The present study assessed THR survival according to country, based on the NARA database with the Finnish data included. Material and methods 438,733 THRs performed during the period 1995–2011 in Sweden, Denmark, Norway, and Finland were included. Kaplan-Meier survival analysis was used to calculate survival probabilities with 95% confidence interval (CI). Cox multiple regression, with adjustment for age, sex, and diagnosis, was used to analyze implant survival with revision for any reason as endpoint. Results: The 15-year survival, with any revision as an endpoint, for all THRs was 86% (CI: 85.7–86.9) in Denmark, 88% (CI: 87.6–88.3) in Sweden, 87% (CI: 86.4–87.4) in Norway, and 84% (CI: 82.9–84.1) in Finland. Revision risk for all THRs was less in Sweden than in the 3 other countries during the first 5 years. However, revision risk for uncemented THR was less in Denmark than in Sweden during the sixth (HR = 0.53, CI: 0.34–0.82), seventh (HR = 0.60, CI: 0.37–0.97), and ninth (HR = 0.59, CI: 0.36–0.98) year of follow-up. Interpretation The differences in THR survival rates were considerable, with inferior results in Finland. Brand-level comparison of THRs in Nordic countries will be required.

Background: A high quality decision requires that patients who meet clinical criteria for surgery are informed about the options (including non-surgical alternatives) and receive treatments that match their goals. The aim of this study was to evaluate the psychometric properties and clinical sensibility of a patient self report instrument, to measure the quality of decisions about total joint replacement for knee or hip osteoarthritis. Methods: The performance of the Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI) was evaluated in two samples: (1) a cross-sectional mail survey with 489 patients and 77 providers (study 1); and (2) a randomized controlled trial of a patient decision aid with 138 osteoarthritis patients considering total joint replacement (study 2). The HK-DQI results in two scores. Knowledge items are summed to create a total knowledge score, and a set of goals and concerns are used in a logistic regression model to develop a concordance score. The concordance score measures the proportion of patients whose treatment matched their goals. Hypotheses related to acceptability, feasibility, reliability and validity of the knowledge and concordance scores were examined. Results: In study 1, the HK-DQI was completed by 382 patients (79%) and 45 providers (58%), and in study 2 by 127 patients (92%), with low rates of missing data. The DQI-knowledge score was reproducible (ICC = 0.81) and demonstrated discriminant validity (68% decision aid vs. 54% control, and 78% providers vs. 61% patients) and content validity. The concordance score demonstrated predictive validity, as patients whose treatments were concordant with their goals had more confidence and less regret with their decision compared to those who did not. Conclusions: The HK-DQI is feasible and acceptable to patients. It can be used to assess whether patients with osteoarthritis are making informed decisions about surgery that are concordant with their goals.

Background and purpose — Hip dislocation is one of the most common complications following total hip arthroplasty (THA). Several factors that affect dislocation have been identified, including acetabular cup positioning. Optimal values for cup inclination and anteversion are debatable. We performed a systematic review to describe the different methods for measuring cup placement, target zones for cup positioning, and the association between cup positioning and dislocation following primary THA. Methods: — A systematic search of literature in the PubMed database was performed (January and February 2016) to identify articles that compared acetabular cup positioning and the risk of dislocation. Surgical approach and methods for measurement of cup angles were also considered. Results:— 28 articles were determined to be relevant to our research question. Some articles demonstrated that cup positioning influenced postoperative dislocation whereas others did not. The majority of articles could not identify a statistically significant difference between dislocating and non-dislocating THA with regard to mean angles of cup anteversion and inclination. Most of the articles that assessed cup placement within the Lewinnek safe zone did not show a statistically significant reduction in dislocation rate. Alternative target ranges have been proposed by several authors. Interpretation— The Lewinnek safe zone could not be justified. It is difficult to draw broad conclusions regarding a definitive target zone for cup positioning in THA, due to variability between studies and the likely multifactorial nature of THA dislocation. Future studies comparing cup positioning and dislocation rate should investigate surgical approach separately. Standardized tools for measurement of cup positioning should be implemented to allow comparison between studies.

Background and purpose According to previous Nordic Arthroplasty Register Association (NARA) data, the 10-year implant survival of cemented total hip arthroplasties (THAs) is 94% in patients aged 65–74 and 96% in patients aged 75 or more. Here we report a brand-level comparison of cemented THA based on the NARA database, which has not been done previously. Patients and methods We determined the rate of implant survival of the 9 most common cemented THAs in the NARA database. We used Kaplan-Meier analysis with 95% CI to study implant survival at 10 and 15 years, and Cox multiple regression to assess survival and hazard ratios (HRs), with revision for any reason as endpoint and with adjustment for age, sex, diagnosis, and femoral head material. Results: Spectron EF THA (89.9% (CI: 89.3–90.5)) and Elite THA (89.8% (CI: 89.0–90.6)) had the lowest 10-year survivorship. Lubinus (95.7% survival, CI: 95.5–95.9), MS 30 (96.6%, CI: 95.8–97.4), and C-stem THA (95.8%, CI: 94.8–96.8) had a 10-year survivorship of at least 95%. Lubinus (revision risk (RR) = 0.77, CI: 0.73–0.81), Müller (RR =0.83, CI: 0.70–0.99), MS-30 (RR =0.73, CI: 0.63–0.86), C-stem (RR =0.70, CI: 0.55–0.90), and Exeter Duration THA (RR =0.84, CI: 0.77–0.90) had a lower risk of revision than Charnley THA, the reference implant. Interpretation The Spectron EF THA and the Elite THA had a lower implant survival than the Charnley, Exeter, and Lubinus THAs. Implant survival of the Müller, MS 30, CPT, and C-stem THAs was above the acceptable limit for 10-year survival.

Background and purpose In traditional radiostereometric analysis (RSA), 1 segment defines both the acetabular shell and the polyethylene liner. However, inserting beads into the polyethylene liner permits employment of the shell and liner as 2 separate segments, enabling distinct analysis of the precision of 3 measurement methods in determining femoral head penetration and shell migration. Patients and methods The UmRSA program was used to analyze the double examinations of 51 hips to determine if there was a difference in using the shell-only segment, the liner-only segment, or the shell + liner segment to measure wear and acetabular cup stability. The standard deviation multiplied by the critical value (from a t distribution) established the precision of each method. Results: Due to the imprecision of the automated edge detection, the shell-only method was least desirable. The shell + liner and liner-only methods had a precision of 0.115 mm and 0.086 mm, respectively, when measuring head penetration. For shell migration, the shell + liner had a precision of 0.108 mm, which was better than the precision of the shell-only method. In both the penetration and migration analyses, the shell + liner condition number was statistically significantly lower and the bead count was significantly higher than for the other methods. Interpretation Insertion of beads in the polyethylene improves the precision of femoral head penetration and shell migration measurements. A greater dispersion and number of beads when combining the liner with the shell generated more reliable results in both analyses, by engaging a larger portion of the radiograph.

Background and purpose Blood metal ion levels can be an indicator for detecting implant failure in metal-on-metal (MoM) hip arthroplasties. Little is known about the effect of bilateral MoM implants on metal ion levels and patient-reported outcomes. We compared unilateral patients and bilateral patients with either an ASR hip resurfacing (HR) or an ASR XL total hip replacement (THR) and investigated whether cobalt or chromium was associated with a broad spectrum of patient outcomes. Patients and methods From a registry of 1,328 patients enrolled in a multicenter prospective follow-up of the ASR Hip System, which was recalled in 2010, we analyzed data from 659 patients (311 HR, 348 THR) who met our inclusion criteria. Cobalt and chromium blood metal ion levels were measured and a 21-item patient-reported outcome measures (PROMs) questionnaire was used mean 6 years after index surgery. Results: Using a minimal threshold of ≥7 ppb, elevated chromium ion levels were found to be associated with worse health-related quality of life (HRQoL) (p < 0.05) and hip function (p < 0.05) in women. These associations were not observed in men. Patients with a unilateral ASR HR had lower levels of cobalt ions than bilateral ASR HR patients (p < 0.001) but similar levels of chromium ions (p = 0.09). Unilateral ASR XL THR patients had lower chromium and cobalt ion levels (p < 0.005) than bilateral ASR XL THR patients. Interpretation Chromium ion levels of ≥7 ppb were associated with reduced functional outcomes in female MoM patients.