Stable fixation of an osseointegated implant system for above-the-knee amputees: titel RSA and radiographic evaluation of migration and bone remodeling in 55 cases.

Background and purposeRehabilitation of patients with transfemoral amputations is particularly difficult due to problems in using standard socket prostheses. We wanted to assess long-term fixation of the osseointegrated implant system (OPRA) using radiostereometric analysis (RSA) and periprosthetic bone remodeling.Methods51 patients with transfemoral amputations (55 implants) were enrolled in an RSA study. RSA and plain radiographs were scheduled at 6 months and at 1, 2, 5, 7, and 10 years after surgery. RSA films were analyzed using UmRSA software. Plain radiographs were graded for bone resorption, cancellization, cortical thinning, and trabecular streaming or buttressing in specifically defined zones around the implant.ResultsAt 5 years, the median (SE) migration of the implant was -0.02 (0.06) mm distally. The rotational movement was 0.42 (0.32) degrees around the longitudinal axis. There was no statistically significant difference in median rotation or migration at any follow-up time. Cancellization of the cortex (plain radiographic grading) appeared in at least 1 zone in over half of the patients at 2 years. However, the prevalence of cancellization had decreased by the 5-year follow-up.InterpretationThe RSA analysis for the OPRA system indicated stable fixation of the implant. The periprosthetic bone remodeling showed similarities with changes seen around uncemented hip stems. The OPRA system is a new and promising approach for addressing the challenges faced by patients with transfemoral amputations

Ambulatory measurement of knee motion and physical activity: preliminary evaluation of a smart activity monitor

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°

Adherence of hip and knee arthroplasty studies to RSA standardization guidelines

Peer reviewe

Radiostereometric Analysis of Tantalum vs. Titanium Acetabular Shells in Young THR Patients

Introduction: In the active total hip replacement (THR) population, maintaining acetabular component stability and limiting polyethylene wear are crucial components to preventing premature implant failure. Titanium with Co/Cr/Mo fiber metal coating is among the most common materials used in cementless THR. Trabecular metal, composed of porous tantalum, has a metallic strut design resembling trabecular bone, designed to improve tissue infiltration and limit migration. This study assesses the stability and clinical outcomes of tantalum versus titanium acetabular shells using radiostereometric analysis (RSA) technology. Methods: In this IRB approved, prospective, randomized, blinded study, 46 patients received a primary THR by a single surgeon (DCA). Each patient was randomized to receive a titanium (23) (Trilogy, Zimmer) or tantalum (23) (Modular tantalum shell, Zimmer) uncemented hemispheric cup and either a highly-crosslinked or conventional polyethylene liner. Tantalum RSA markers were implanted around the liner periphery, femur, and periacetabular bone in each patient. RSA examinations, Harris Hip, UCLA, WOMAC, SF-36 scores were obtained at 10 days, 6 months, and annually with the furthest patients evaluated through 5 years. Results: Median translation was greater at all time points for the tantalum mesh cups except for the 3-year follow-up, however due to large standard errors, there was no significant difference between the two designs (p\u3e0.05). These large standard errors were predominantly caused by two outliers, neither of which had clinical evidence of loosening at 5 years follow-up. Mean UCLA, WOMAC, Harris Hip, and SF-36 PCS and MCS scores improved similarly in both groups. Conclusions: In this young THR population, both titanium and tantalum acetabular shells demonstrated excellent stability at five years follow up. Tantalum shells demonstrated slightly greater micromotion, but there was no statistically significant difference in shell migration. Outstanding clinical outcomes with statistically significant improvements in function and pain relief were observed in both groups

Radiostereometric Analysis of Femoral Head Penetration in Cross-Linked Polyethylene in THR Patients

Background: In the young total hip replacement (THR) population limiting polyethylene liner wear is crucial to preventing premature implant failure. Highly cross-linked ultra-high molecular weight polyethylene (HXLPE) liners were designed to improve wear resistance of polyethylene liners. Radiostereometric analysis (RSA) provides highly precise measurements of liner wear. This study utilized RSA to characterize wear of conventional versus HXLPE liners up to five years following THR. Methods: This IRB-approved, prospective, randomized, blinded study, involved 46 patients with a mean age of 58 and BMI of 30. Each patient was double randomized to receive a conventional or HXLPE liner with an uncemented titanium mesh or tantalum trabecular metal cup. Both liners were prepared from compression-molded GUR 1050 resin without calcium stearate, while HXLPE liners undergo further e-beam irradiation and annealing. At the time of surgery, 1mm tantalum RSA markers were implanted around the liner periphery, femur and periacetabular bone. RSA examinations, Harris Hip, UCLA, WOMAC, SF-36 scores were obtained pre-operatively, post-operatively, at six weeks, six months and annually through five years. Results: All patients had statistically significant improvement in Harris Hip, WOMAC and SF-36 PCS scores following THR with no difference between cohorts. On RSA examination, of titanium shells, HXLPE liners revealed significantly lower femoral head penetration at each follow up except six weeks and six months (p Conclusion: In this young THR population RSA shows significantly less femoral head penetration in the HXLPE liners compared to conventional liners. Novel RSA techniques have been developed to determine polyethylene wear in patients

Worse health-related quality of life and hip function in female patients with elevated chromium levels: A prospective study of 659 patients with a recalled THR metal-on-metal implant

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

Countrywise results of total hip replacement. An analysis of 438,733 hips based on the Nordic Arthroplasty Register Association database

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

Twelve-Year Risk of Revision After Primary Total Hip Replacement in the U.S. Medicare Population

There is limited population-based literature on rates and risk factors for revision following primary total hip replacement

Failure rate of cemented and uncemented total hip replacements: register study of combined Nordic database of four nations

Objective: To assess the failure rate of cemented, uncemented, hybrid, and reverse hybrid total hip replacements in patients aged 55 years or older. Design: Register study. Setting: Nordic Arthroplasty Register Association database (combined data from Sweden, Norway, Denmark, and Finland). Participants: 347 899 total hip replacements performed during 1995-2011. Main outcome measures: Probability of implant survival (Kaplan-Meier analysis) along with implant survival with revision for any reason as endpoint (Cox multiple regression) adjusted for age, sex, and diagnosis in age groups 55-64, 65-74, and 75 years or older. Results: The proportion of total hip replacements using uncemented implants increased rapidly towards the end of the study period. The 10 year survival of cemented implants in patients aged 65 to 74 and 75 or older (93.8%, 95% confidence interval 93.6% to 94.0% and 95.9%, 95.8% to 96.1%, respectively) was higher than that of uncemented (92.9%, 92.3% to 93.4% and 93.0%, 91.8% to 94.0%), hybrid (91.6%, 90.9% to 92.2% and 93.9%, 93.1% to 94.5%), and reverse hybrid (90.7%, 87.3% to 93.2% and 93.2%, 90.7% to 95.1%) implants. The survival of cemented (92.2%, 91.8% to 92.5%) and uncemented (91.8%, 91.3% to 92.2%) implants in patients aged 55 to 64 was similar. During the first six months the risk of revision with cemented implants was lower than with all other types of fixation in all age groups. Conclusion: The survival of cemented implants for total hip replacement was higher than that of uncemented implants in patients aged 65 years or older. The increased use of uncemented implants in this age group is not supported by these data. However, because our dataset includes only basic information common to all national registers there is potential for residual confounding.publishedVersio