Patient-reported outcome correlates with knee function after a single-design mobile-bearing TKA.
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ABSTRACT:
SUBMITTER: Argenson JN
PROVIDER: S-EPMC2565059 | biostudies-other | 2008 Nov
REPOSITORIES: biostudies-other
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Project description:Background and purpose - Mobile-bearing total knee prostheses (TKPs) were developed in the 1970s in an attempt to increase function and improve implant longevity. However, modern fixed-bearing designs like the single-radius TKP may provide similar advantages. We compared tibial component migration measured with radiostereometric analysis (RSA) and clinical outcome of otherwise similarly designed cemented fixed-bearing and mobile-bearing single-radius TKPs. Patients and methods - RSA measurements and clinical scores were assessed in 46 randomized patients at baseline, 6 months, 1 year, and annually thereafter up to 6 years postoperatively. A linear mixed-effects model was used to analyze the repeated measurements. Results - Both groups showed comparable migration (p = 0.3), with a mean migration at 6-year follow-up of 0.90?mm (95% CI 0.49-1.41) for the fixed-bearing group compared with 1.22?mm (95% CI 0.75-1.80) for the mobile-bearing group. Clinical outcomes were similar between groups. 1 fixed-bearing knee was revised for aseptic loosening after 6 years and 2 knees (1 in each group) were revised for late infection. 2 knees (1 in each group) were suspected for loosening due to excessive migration. Another mobile-bearing knee was revised after an insert dislocation due to failure of the locking mechanism 6 weeks postoperatively, after which study inclusion was preliminary terminated. Interpretation - Fixed-bearing and mobile-bearing single-radius TKPs showed similar migration. The latter may, however, expose patients to more complex surgical techniques and risks such as insert dislocations inherent to this rotating-platform design.
| S-EPMC5901517 | biostudies-literature
Project description:Although the design features of the Medial Pivot fixed-bearing prosthesis reportedly improve kinematics compared with TKAs using fixed-bearings, clinical improvements have not been reported. We asked whether the clinical and radiographic outcomes, ranges of motion of the knee, patient satisfaction, and complication rates would be better in knees with a Medial Pivot fixed-bearing prosthesis than in those with a PFC Sigma mobile-bearing prosthesis. We compared the results of 92 patients who had a Medial Pivot fixed-bearing prosthesis implanted in one knee and a PFC Sigma mobile-bearing prosthesis implanted in the other. There were 85 women and seven men with a mean age of 69.5 years (range, 55-81 years). The minimum followup was 2 years (mean, 2.6 years; range, 2-3 years). The patients were assessed clinically and radiographically using the rating systems of the Hospital for Special Surgery and the Knee Society at 3 months, 1 year, and annually thereafter. Contrary to expectations, we found worse early clinical outcomes, smaller ranges of knee motion, less patient satisfaction, and a higher complication rate for the Medial Pivot fixed-bearing prosthesis than for the PFC Sigma mobile-bearing prosthesis.Level I, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.
| S-EPMC2628493 | biostudies-other
Project description:UNLABELLED: Controversy exists as to whether bearing mobility facilitates centralization of the extensor mechanism after TKA. To assess the incidence of lateral retinacular release, we retrospectively reviewed 1318 consecutive primary TKAs (1032 patients) performed by one surgeon using either a rotating-platform bearing (940) or a fixed bearing (378) from the same implant system. The selection of a fixed- versus mobile-bearing TKA was primarily based on age with patients younger than 70 years receiving a mobile-bearing TKA. We performed a lateral release whenever continuous symmetric patellar facet contact with the trochlear groove from 0 degrees to 90 degrees of flexion was not obtained using the rule of no thumb after tourniquet release. One hundred four of 1318 knees (7.9%) had a lateral release. We performed more lateral releases in the fixed-bearing group (14.3% [54 of 378]) than in the mobile-bearing group (5.3% [50 of 940]). Patellar tilt occurred more often in the mobile-bearing group (10% [94 of 940]) than in the fixed-bearing group (6.9% [26 of 378]), although the magnitude of mean patellar tilt was small in both groups (mobile-bearing 3.0 degrees ; fixed bearing 2.55 degrees ). No patient had patellar subluxation greater than 5 mm. We suspect the fewer lateral releases in the mobile-bearing group is the result of better extensor mechanism centralization provided by bearing rotation. LEVEL OF EVIDENCE: Level III, prognostic study. See the Guidelines for a complete description of levels of evidence.
| S-EPMC2565058 | biostudies-other
Project description:BackgroundDespite the overall effectiveness of total knee arthroplasty (TKA), a subset of patients do not experience expected improvements in pain, physical function, and quality of life as documented by patient-reported outcome measures (PROMs), which assess a patient's physical and emotional health and pain. It is therefore important to develop preoperative tools capable of identifying patients unlikely to improve by a clinically important margin after surgery.Questions/purposesThe purpose of this study was to determine if an association exists between preoperative PROM scores and patients' likelihood of experiencing a clinically meaningful change in function 1 year after TKA.MethodsA retrospective study design was used to evaluate preoperative and 1-year postoperative Knee injury and Osteoarthritis Outcome Score (KOOS) and SF-12 version 2 (SF12v2) scores from 562 patients who underwent primary unilateral TKA. This cohort represented 75% of the 750 patients who underwent surgery during that time period; a total of 188 others (25%) either did not complete PROM scores at the designated times or were lost to follow-up. Minimum clinically important differences (MCIDs) were calculated for each PROM using a distribution-based method and were used to define meaningful clinical improvement. MCID values for KOOS and SF12v2 physical component summary (PCS) scores were calculated to be 10 and 5, respectively. A receiver operating characteristic analysis was used to determine threshold values for preoperative KOOS and SF12v2 PCS scores and their respective predictive abilities. Threshold values defined the point after which the likelihood of clinically meaningful improvement began to diminish. Multivariate regression was used to control for the effect of preoperative mental and emotional health, patient attributes quantified by SF12v2 mental component summary (MCS) scores, on patients' likelihood of experiencing meaningful improvement in function after surgery.ResultsThreshold values for preoperative KOOS and SF12v2 PCS scores were a maximum of 58 (area under the curve [AUC], 0.76; p < 0.001) and 34 (AUC, 0.65; p < 0.001), respectively. Patients scoring above these thresholds, indicating better preoperative function, were less likely to experience a clinically meaningful improvement in function after TKA. When accounting for mental and emotional health with a multivariate analysis, the predictive ability of both KOOS and SF12v2 PCS threshold values improved (AUCs increased to 0.80 and 0.71, respectively). Better preoperative mental and emotional health, as reflected by a higher MCS score, resulted in higher threshold values for KOOS and SF12v2 PCS.ConclusionsWe identified preoperative PROM threshold values that are associated with clinically meaningful improvements in functional outcome after TKA. Patients with preoperative KOOS or SF12v2 PCS scores above the defined threshold values have a diminishing probability of experiencing clinically meaningful improvement after TKA. Patients with worse baseline mental and emotional health (as defined by SF12v2 MCS score) have a lower probability of experiencing clinically important levels of functional improvement after surgery. The results of this study are directly applicable to patient-centered informed decision-making tools and may be used to facilitate discussions with patients regarding the expected benefit after TKA.Level of evidenceLevel III, prognostic study.
| S-EPMC5174023 | biostudies-literature
Project description:It is unclear whether mobile-bearing (MB) total knee arthroplasties reduce the risk of tibial component loosening compared to fixed-bearing (FB) designs. This randomized study investigated implant migration, periprosthetic bone mineral density (BMD), and patient-reported outcomes (Oxford knee score)-all at 2 years-for the P.F.C. Sigma Cruciate Retaining total knee arthroplasty.50 osteoarthritis patients were allocated to either FB or MB tibial articulation.At 2 years, the mean total translation (implant migration) was higher for the FB implant (0.30 mm, SD 0.22) than for the MB implant (0.17 mm, SD 0.09) (p = 0.04). BMD decreased between baseline and 1-year follow-up. At 2-year follow-up, BMD was close to the baseline level. The knee scores of both groups improved equally well. The FB tibial implant migrated more than the MB, but this was not clinically significant. The mobile polyethylene presumably partly absorbs the force transmitted to the metal tibial tray, thereby reducing micromotion.
| S-EPMC4404772 | biostudies-literature
Project description:BackgroundThere is currently limited evidence on the level and intensity of physical activity in individuals with hemophilia A. Mobile technologies can offer a rigorous and reliable alternative to support data collection processes but they are often associated with poor user retention. The lack of longitudinal continuity in their use can be partly attributed to the insufficient consideration of stakeholder inputs in the development process of mobile apps. Several user-centered models have been proposed to guarantee that a thorough knowledge of the end user needs is considered in the development process of mobile apps.ObjectiveThe aim of this study is to design and validate an electronic patient-reported outcome mobile app that requires sustained active input by individuals during POWER, an observational study that aims at evaluating the relationship between physical activity levels and bleeding in patients with hemophilia A.MethodsWe adopted a user-centered design and engaged several stakeholders in the development and usability testing of this mobile app. During the concept generation and ideation phase, we organized a need-assessment focus group (FG) with patient representatives to elicit specific design requirements for the end users. We then conducted 2 exploratory FGs to seek additional inputs for the app's improvement and 2 confirmatory FGs to validate the app and test its usability in the field through the mobile health app usability questionnaire.ResultsThe findings from the thematic analysis of the need-assessment FG revealed that there was a demand for sense making, for simplification of app functionalities, for maximizing integration, and for minimizing the feeling of external control. Participants involved in the later stages of the design refinement contributed to improving the design further by upgrading the app's layout and making the experience with the app more efficient through functions such as chatbots and visual feedback on the number of hours a wearable device had been worn, to ensure that the observed data were actually registered. The end users rated the app highly during the quantitative assessment, with an average mobile health app usability questionnaire score of 5.32 (SD 0.66; range 4.44-6.23) and 6.20 (SD 0.43; range 5.72-6.88) out of 7 in the 2 iterative usability testing cycles.ConclusionsThe results of the usability test indicated a high, growing satisfaction with the electronic patient-reported outcome app. The adoption of a thorough user-centered design process using several types of FGs helped maximize the likelihood of sustained retention of the app's users and made it fit for data collection of relevant outcomes in the observational POWER study. The continuous use of the app and the actual level of engagement will be evaluated during the ongoing trial.Trial registrationClinicalTrials.gov NCT04165135; https://clinicaltrials.gov/ct2/show/NCT04165135.
| S-EPMC8686465 | biostudies-literature
Project description:BackgroundSmartphones offer the possibility of assessing recovery of mobility after total hip or knee arthroplasty (THA or TKA) passively and reliably, as well as facilitating the collection of patient-reported outcome measures (PROMs) with greater frequency.Questions/purposesWe investigated the feasibility of using mobile technology to collect daily step data and biweekly PROMs to track recovery after total joint arthroplasty.MethodsPre- and post-operative daily steps were recorded in prospectively enrolled patients (128 THA and 139 TKA) via an app, which uses the phone's accelerometer. During 6-month follow-up, patients also completed PROMs (the pain numeric rating scale, the Hip Disability and Osteoarthritis Outcome Score Joint Replacement [HOOS JR] and the Knee Injury and Osteoarthritis Outcome Score Joint Replacement [KOOS JR]), and HOOS or KOOS JR quality of life domain via a mobile-enabled web link.ResultsAt least 6 months of follow-up was completed by 65% for THA and 68% for TKA patients. Reasons for non-completion included time commitment, phone battery, app issues, and health complications. Responses from 78% of requested PROMs were returned with 96% of patients returning at least one post-operative PROM. Step data were available from 92% of days from male patients and 86% of days from female patients. The most robust recovery occurred early, within the first 2 months. The groups with higher pre-operative steps were more likely to recover their maximum daily steps at an earlier time point. Correlations between step counts and PROMs scores were modest.ConclusionAssessing large amounts of post-TKA and post-THA step data using mobile technology is feasible. Completion rates were good, making the technology very useful for collecting frequent PROMs. Being unable to ensure that patients always carried their phones limited our analysis of the step counts.
| S-EPMC7749883 | biostudies-literature
Project description:Mobile bearing (MB) total knee design has been advocated as a means to enhance the functional characteristics and decrease the wear rates of condylar total knee arthroplasty (TKA). However, it is unclear if these designs achieve these goals.We asked whether function of patients or survivorship would be greater or complications would be lesser in groups of patients with MB compared with fixed bearing (FB) TKA. We also sought to describe retrieval findings.We randomized 507 primary TKAs in 416 eligible patients to receive MB (n = 252) or FB (n = 255) devices from November 2001 to August 2007 (Investigational Device Exemption G000180, ClinicalTrials.gov registration number NCT00946075). Patients were blinded to treatment allocation. WOMAC Index, SF-12 Health Survey, knee range of motion, and Knee Society scores were collected and compared preoperatively and at 6, 12, and 24 months postoperatively. We recorded device failures and complications until October 2009. Kaplan-Meier survivorship was compared using the log rank test. Twelve retrieved MB devices underwent pathologic analysis. The minimum postoperative time was 2.2 years (mean, 5.9 years; range, 2.2-7.9 years).We found no differences in mean clinical assessment scores or mean score changes from baseline at any postoperative interval through 2 postoperative years. Nineteen of the 252 MB and 13 of the 255 FB knees had undergone revision of any component. Estimated survival at 6 postoperative years was similar for the two devices: 90.1% (95% confidence interval [CI], 84.1-93.9) for MB and 94.2% (95% CI, 90.1-96.6) for FB. Two MB and no FB tibial components were revised for loosening. There was one case of MB insert dislocation. Retrieved MB devices demonstrated no unexpected wear or mechanical device failures.We found no evidence of functional advantage of the MB design. Survivorship was similar, although the study is limited by short duration of followup.
| S-EPMC3238000 | biostudies-literature
Project description:BACKGROUND:In the past years, a mobile health (mHealth) app called the Dutch Talking Touch Screen Questionnaire (DTTSQ) was developed in The Netherlands. The aim of development was to enable Dutch physical therapy patients to autonomously complete a health-related questionnaire regardless of their level of literacy and digital skills. OBJECTIVE:The aim of this study was to evaluate the usability (defined as the effectiveness, efficiency, and satisfaction) of the prototype of the DTTSQ for Dutch physical therapy patients with diverse levels of experience in using mobile technology. METHODS:The qualitative Three-Step Test-Interview method, including both think-aloud and retrospective probing techniques, was used to gain insight into the usability of the DTTSQ. A total of 24 physical therapy patients were included. The interview data were analyzed using a thematic content analysis approach aimed at analyzing the accuracy and completeness with which participants completed the questionnaire (effectiveness), the time it took the participants to complete the questionnaire (efficiency), and the extent to which the participants were satisfied with the ease of use of the questionnaire (satisfaction). The problems encountered by the participants in this study were given a severity rating that was used to provide a rough estimate of the need for additional usability efforts. RESULTS:All participants within this study were very satisfied with the ease of use of the DTTSQ. Overall, 9 participants stated that the usability of the app exceeded their expectations. The group of 4 average-/high-experienced participants encountered only 1 problem in total, whereas the 11 little-experienced participants encountered an average of 2 problems per person and the 9 inexperienced participants an average of 3 problems per person. A total of 13 different kind of problems were found during this study. Of these problems, 4 need to be addressed before the DTTSQ will be released because they have the potential to negatively influence future usage of the tool. The other 9 problems were less likely to influence future usage of the tool substantially. CONCLUSIONS:The usability of the DTTSQ needs to be improved before it can be released. No problems were found with satisfaction or efficiency during the usability test. The effectiveness needs to be improved by (1) making it easier to navigate through screens without the possibility of accidentally skipping one, (2) enabling the possibility to insert an answer by tapping on the text underneath a photograph instead of just touching the photograph itself, and (3) making it easier to correct wrong answers. This study shows the importance of including less skilled participants in a usability study when striving for inclusive design and the importance of measuring not just satisfaction but also efficiency and effectiveness during such studies.
| S-EPMC6789421 | biostudies-literature
Project description:BackgroundWe sought to determine the 10-year survivorship and reasons for revision for a fixed-bearing unicompartmental knee arthroplasty (UKA) design. In addition, we report on patient-reported outcomes and satisfaction and compare results of medial vs lateral compartment UKA and cemented vs cementless UKA with the same design.MethodsWe performed a retrospective cohort study on a single-surgeon case series using a single fixed-bearing UKA design in 158 consecutive patients who underwent 177 UKA procedures between July 2000 and December 2010. Cases missing follow-up within the last year, clinically or via telephone, were excluded (n = 17, 10%). A cumulative incidence competing risk model was used to evaluate the cumulative incidence of failure.ResultsCumulative incidence of revision at a mean follow-up of 10 years was 13%. The majority of revisions (43%, 10/23) were for aseptic tibial component loosening, followed by progression of osteoarthritis (5/23, 22%). All Patient Reported Outcomes Measurement Information System measures demonstrated mean T-scores within one standard deviation from the US population norm. The mean Knee Injury and Osteoarthritis Outcome Score for Joint Replacement was 96.9 (range, 40-100). The mean pain score was 3.8 (range, 0-8). Eighty-six percent of patients were satisfied with the UKA.ConclusionsAt 10-year follow-up, the most common causes for revision were aseptic tibial loosening and adjacent compartment knee arthroplasty, and similar results were found for medial vs lateral compartment and for cemented vs cementless UKA. Surgeons should consider these findings for future UKA designs, and this represents the first study reporting on survivorship and outcomes of this specific UKA design.
| S-EPMC7303483 | biostudies-literature