Background: Development of patient-reported outcomes (PROs) to include traditionally clinic -reported data has the potential to decrease the data-collection burden for patients and clinicians and increase follow-up rates. However, replacing clinic report by patient report requires that the data reasonably agree.Objective: To assess agreement between PROs and clinical registry data at 1 year after bariatric surgery. Setting: Not-for-profit organization, bariatric surgery data registry, PROs platform.Methods: Patient-and clinic-reported 1-year postoperative weight and co-morbidities were compared for matched PROs and registry records. The co-morbidities evaluated were diabetes, sleep apnea, hypertension, gastroesophageal reflux disease, and hyperlipidemia. Weight differ-ence in pounds and nominal groupings (binary, 4-level) for co-morbidities were assessed for agreement between data sources using descriptive statistics, Bland-Altman plots, multiple regression, and kappa coefficients. Sensitivity analyses and follow-up by response method were examined.Results: Among 1130 patients with both 1-year PROs and registry weights, 95% of patient-reported weights were within 13 lb of the registry-recorded weight, and patients underreported their weight by w2 lb, on average. Percent agreement and kappa coefficients were highest for diabetes (n = 999; bi-nary: 94%, K = .72; 4-level: 86%, K = .71) and lowest for gastroesophageal reflux disease (n = 1032; binary: 75%, K = .40; 4-level: 57%, K = .35). Of patients eligible for both PROs and registry 1-year follow-up, 21% had PROs only.Conclusions: One-year patient-and clinic-reported weights and disease status for patients with dia-betes and hypertension showed high agreement. The degree of bias from patient report was low. Patient report is a viable alternative to clinic report for certain objective measurements and may increase follow-up. (Surg Obes Relat Dis 2023;19:309-317.)(c) 2023 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

IntroductionThe large diameter mobile polyethylene liner of the dual mobility implant provides increased resistance to hip dislocation. However, a problem specific to the dual mobility system is intra-prosthetic dislocation (IPD), secondary to loss of the retentive rim, causing the inner head to dissociate from the polyethylene liner. We hypothesized that impingement of the polyethylene liner with the surrounding soft-tissue inhibits liner motion, thereby facilitating load transfer from the femoral neck to the liner and leading to loss of retentive rim over time. This mechanism of soft-tissue impingement with the liner was evaluated via cadaver experiments, and retrievals were used to assess polyethylene rim damage.MethodsTotal hip arthroplasty was performed on 10 cadaver hips using 3D printed dual mobility components. A metal wire was sutured to the posterior surface (underside) of the iliopsoas, and metal wires were embedded into grooves on the outer surface of the liner and inner head to identify these...

IntroductionOsteolysis caused by wear of the ultrahigh molecular weight polyethylene (UHMWPE) often leads to failure. Cross-linking improves wear, but also produces residual free radicals that decr...

Summary StatementIn young, active patients cementless THR demonstrates excellent prosthetic stability by RSA and outstanding clinical outcomes at 5 years using a tapered titanium femoral stem, cros...

Background: New materials in cementless total hip arthroplasty are continuously introduced into clinical practice. The objective of this study was to compare the radiographic and clinical performances of acetabular shells made with porous titanium coating (PTC) and plasma-sprayed titanium (PS). Methods: Data from a prospective multicenter study monitoring PTC and PS shells were analyzed. Three hundred and eighty patients (191 with PTC and 189 with PS) with postoperative (within 10 months after the operation) and 5-year radiographs were available for assessment of radiographic outcomes and patient-reported outcome measures (PROMs). A radiolucent distance between the cup and acetabulum of ≥0.5 mm was defined as a gap if it was found on a postoperative radiograph and as a radiolucency if it was found on a later follow-up radiograph for the first time. Results: Postoperative gaps were more common with the PS shell (40% versus 24%, p < 0.001). However, a higher percentage of the gaps in the PTC group persisted at 5 years (56% versus 4%, p < 0.001). At 5 years, 23% of the PTC shells had a radiolucency versus 5% of the PS shells (p < 0.001). Logistic regression revealed a 5.2-fold increase in the odds for radiolucency with the PTC shell (p < 0.001). No patient underwent revision surgery due to acetabular component loosening within the study period. A PTC shell was the only factor associated with the risk of pain in a logistic regression model (odds ratio = 2.0, p = 0.035). Conclusions: PTC shells were associated with more patient-reported pain and a higher risk of radiolucency and a persistent gap at 5 years compared with the PS shells, although these outcomes were not related to each other. The clinical relevance of the radiographic findings is unclear as no prostheses were revised because of loosening, but the findings warrant additional follow-up studies. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Value-based health care aims to optimize the balance of patient outcomes and health care costs. To improve value in perinatal care using this strategy, standard outcomes must first be defined. The objective of this work was to define a minimum, internationally appropriate set of outcome measures for evaluating and improving perinatal care with a focus on outcomes that matter to women and their families.

The authors regret that there were incorrect values in Table 1. The corrected values are presented in bold in the Table below.Table 1Study demographics, follow-up status, and implant allocation at Centers 1 and 2.DemographicsCenter 1Center 2Patients enrolled48 (52 hips)32 (32 hips)Count at 3 years43 (47 hips)31 (31 hips)GenderFemale 15 (31%)Male 33 (69%)Female 16 (50%)Male 16 (50%)Mean age ± standard deviation (years)59 ± 1166 ± 8Revisions1 Infection1 InstabilityReadable 3 year RSA Radiograph Pairs37 (cup migration)46 (penetration)20 (cup migration)29 (penetration)Ceramic heads-32Cobalt chrome heads52- Open table in a new tab The authors would like to apologize for any inconvenience caused. Three Year RSA Evaluation of Vitamin E Diffused Highly Cross-linked Polyethylene Liners and Cup StabilityThe Journal of ArthroplastyVol. 30Issue 7PreviewVitamin E diffusion into highly cross-linked polyethylene (E-XLPE) is a method for enhancing oxidative stability of acetabular liners. The purpose of this study was to evaluate in vivo penetration of E-XLPE using radiostereometric analysis (RSA). Eighty-four hips were recruited into a prospective 10-year RSA. This is the first evaluation of the multicenter cohort after 3-years. All patients received E-XLPE liners (E1, Biomet) and porous-titanium coated cups (Regenerex, Biomet). There was no difference (P = 0.450) in median femoral head penetration into the E-XLPE liners at 3-years comparing cobalt-chrome heads (−0.028 mm; inter-quartile range (IQR) — 0.065 to 0.047) with ceramic heads (−0.043 mm, IQR — 0.143 to 0.042). Full-Text PDF

IntroductionIn vitro studies showed that the anti-oxidative properties of vitamin E stabilize free radicals while retaining the mechanical strength of UHMWPE. The purpose was to evaluate vitamin E ...

Aims The objective of this five-year prospective, blinded, randomised controlled trial (RCT) was to compare femoral head penetration into a vitamin E diffused highly cross-linked polyethylene (HXLPE) liner with penetration into a medium cross-linked polyethylene control liner using radiostereometric analysis. Patients and Methods Patients scheduled for total hip arthroplasty (THA) were randomised to receive either the study E1 (32 patients) or the control ArComXL polyethylene (35 patients). The median age (range) of the overall cohort was 66 years (40 to 76). Results The five-year median (interquartile range) proximal femoral head penetration into the E1 was -0.05 mm (-0.13 to -0.02) and 0.07 mm (-0.03 to 0.16) for ArComXL. At three and five years, the penetration was significantly greater in the ArComXL group compared with the E1 group (p = 0.029 and p = 0.019, respectively). All patient-reported outcomes (PROs) improved significantly from the pre-operative interval compared with those at one year, and remained favourable at five years. There were no differences between the two groups at any interval. Conclusion The five-year results showed that E1 polyethylene does not wear more than the control, ArComXL. This is the longest-term RCT comparing the wear performance and clinical outcome of vitamin E diffused HXLPE with a previous generation of medium cross-linked polyethylene. Cite this article: Bone Joint J 2017;99-B:577–84.

The Patient Centered Outcomes Research Institute (PCORI) funded a 4-year project to determine the comparative effectiveness of metabolic and bariatric surgical procedures using patient-reported outcomes. This LOBSTER PROMs project (Long-term Outcomes of Bariatric Surgical Techniques and their Effect on Related Patient-Reported Outcome Measures) will implement PROMs into the MBSAQIP for national dissemination.

Background: The objective of this study was to assess the retentive rim of retrieved dual mobility liners for visible evidence of deformation from femoral neck contact and to use cadaver models to determine if anterior soft tissue impingement could contribute to such deformation.Methods: Fifteen surgically retrieved polyethylene liners were assessed for evidence of rim deformation. The average time in vivo was 31.4 months, and all patients were revised for reasons other than intraprosthetic dislocation. Liner interaction with the iliopsoas was studied visually and with fluoroscopy in cadaver specimens using a dual mobility system different than the retrieval study. For fluoroscopic visualization, a metal wire was sutured to the iliopsoas and wires were also embedded into grooves on the outer surface of the liner and the inner head.Results: All retrievals showed evidence of femoral neck contact. The cadaver experiments showed that liner motion was impeded by impingement with the iliopsoas tendon in low flexion angles. When observing the hip during maximum hyperextension, 0 degrees, 15 degrees, and 30 degrees of flexion, there was noticeable tenting of the iliopsoas caused by impingement with the liner.Conclusion: Liner rim deformation resulting from contact with the femoral neck likely begins during early in vivo function. The presence of deformation is indicative of a mechanism inhibiting mobility of the liner. The cadaver studies showed that liner motion could be impeded because of its impingement with the iliopsoas. Such soft tissue impingement may be one mechanism by which liner motion is routinely inhibited, which can result in load transfer from the neck to the rim. (C) 2015 Elsevier Inc. All rights reserved.

Background: The objective of this 13-year prospective evaluation of highly cross-linked ultra high molecular weight polyethylene (HXLPE) was to (1) assess the long-term wear of HXLPE articulating with 2 femoral head sizes using radiostereometric analysis (RSA) and to (2) determine if osteolysis is a concern with this material through the use of plain radiographs and computerized tomography (CT).Methods: All patients received a Longevity HXLPE liner with tantalum beads and either a 28-mm or 36-mm femoral head. Twelve patients (6 in each head size group) agreed to return for 13-year RSA, plain radiograph, and CT follow-up. The 1-year and 13-year plain radiographs as well as the CT scans were analyzed for the presence of osteolysis.Results: The 13-year mean +/- standard error steady-state wear was 0.05 +/- 0.02 mm with no significant increase over time or between the 2 head size groups. Two patients' CT scans showed radiolucent regions in the acetabulum of 4.51 cm(3) and 11.25 cm(3), respectively. In one patient, this area corresponded to a partially healed degenerative cyst treated with autograft during surgery. The second patient had an acetabular protrusio treated with autograft, and the CT scan revealed areas of remodeling of this graft. One patient's 13-year plain radiographs showed evidence of cup loosening and linear radiolucencies in zones 2 and 3.Conclusion: There was no evidence of significant wear over time using RSA. The CT scans did not show evidence of osteolysis due to wear particles. These results suggest that this material has reduced wear compared to conventional polyethylene, irrespective of head size. (C) 2016 Elsevier Inc. All rights reserved.

Background and purpose — Patients with anxiety and/or depression tend to report less pain reduction and less satisfaction with surgical treatment. We hypothesized that the use of antidepressants would be correlated to patient-reported outcomes (PROs) 1 year after total hip replacement (THR), where increased dosage or discontinuation would be associated with worse outcomes.Patients and methods — THR cases with pre- and postoperative patient-reported outcome measures (PROMs) were selected from the Swedish Hip Arthroplasty Register (n = 9,092; women: n = 5,106). The PROMs were EQ-5D, visual analog scale (VAS) for pain, Charnley class, and VAS for satisfaction after surgery. These cases were merged with a national database of prescription purchases to determine the prevalence of antidepressant purchases. Regression analyses were performed where PROs were dependent variables and sex, age, Charnley class, preoperative pain, preoperative health-related quality of life (HRQoL), patient-reported anxiety/depression, and antidepressant use were independent variables.Results — Antidepressants were used by 10% of the cases (n = 943). Patients using antidepressants had poorer HRQoL and higher levels of pain before and after surgery and they experienced less satisfaction. Preoperative antidepressant use was independently associated with PROs 1 year after THR regardless of patient-reported anxiety/depression.Interpretation — Antidepressant usage before surgery was associated with reduced PROs after THR. Cases at risk of poorer outcomes may be identified through review of the patient's medical record. Clinicians are encouraged to screen for antidepressant use preoperatively, because their use may be associated with PROs after THR.

Background: Vitamin Eediffused highly cross-linked polyethylene (VEPE) was developed to reduce oxidation without compromising mechanical strength. The purpose of this study was to evaluate VEPE in vivo using radiostereometric analysis (RSA) and patient-reported outcome measures (PROMs). Methods: Fifty-one hips were enrolled. Each patient received a VEPE liner, a porous titanium shell, and an uncemented stemwith a 32-mm cobaltechrome femoral head. Tantalum beads were inserted into the VEPE to measure femoral head penetration using RSA. RSA radiographs and PROMs were obtained preoperatively immediately after surgery, 6 months, 1, 2, 3, and 5 years after surgery. Results: Forty-seven hips returned at 3 years, and 42 hip at 5 years. The mean ± standard error of the mean proximal head penetration into the polyethylene was 0.06 ± 0.01 at 5 years. The amount of head penetration did not change significantly with increasing time in vivo. The mean ± standard error of the mean Harris Hip Score was 58 ± 2 preoperatively, which improved significantly to 93 ± 2 at 5 years (P < .001). Conclusion: The head penetration into VEPE liners was low compared with non-VEPE at 5 years. After settling of the liners in the early period, no significant head penetration occurred from 2to 5-year follow-up. All PROMs improved significantly from preoperative to postoperative and remained very favorable at 5 years. This study documents the longest-term evaluation of in vivo wear performance of

Purpose Preclinical studies of vitamin E diffused highly cross-linked polyethylene (E-XLPE) has shown enhanced mechanical properties with less wear. The purpose of our study was to document the early clinical outcome of E-XLPE to ensure, for the safety of patients, that there are no unforeseen early adverse events from using this new biomaterial. Methods The enrolled patients (n = 977) have received either a porous titanium coated or porous plasma sprayed acetabular shell with either a E-XLPE liner or a medium cross-linked (AXL) liner. At each follow-up 5 patient-reported outcome measures (PROMs) were completed: Harris Hip Score, Case Mix Indicator, UCLA Activity Score, SF-36, and EQ-5D. Radiographs were measured for cup and stem position, as well as femoral head penetration into the liner (wear). Postoperative complications and revisions were collected. Results At 3 years follow-up, there were 13 revisions due to: 4 periprosthetic fractures; 1 sepsis; 6 instabilities; and 2 implant mismatches at surgery. Wear of the hip implant, calculated by software analysis of pelvis x-rays, from the postoperative interval to 3 years showed a liner penetration rate of 0.027 mm/year for AXL and 0.005 mm/year for E-XLPE with no significant difference between the 2 (p = 0.24). Improvement was seen in all PROMs from the preoperative interval to 3 years after surgery (p<0.0001). Conclusions Early follow-up of the E-XLPE and AXL liners show low penetration. PROMs indicate improvement after total hip arthroplasty in functionality and quality of life across the centers. We have not observed any early in vivo adverse effects from diffusing the liners with vitamin E. Trial registration ClinicalTrials.gov Identifier: NCT00545285.

Background: Persistent acetabular dysplasia (AD) after periacetabular osteotomy has been hypothesized to increase the risk for malpositioning of the acetabular component. In this study, we investigate whether AD is an independent risk factor for cup malpositioning during primary total hip arthroplasty (THA).Methods: Patient demographics, surgical approach, presence of AD assessed using the lateral center-edge angle, and acetabular cup positioning determined using Martell Hip Analysis Suite were investigated in 836 primary THA patients enrolled in a prospective multicenter study.Results: We found that presence of AD, defined as the lateral center-edge angle of <25 degrees, is an independent risk factor for malpositioning of the acetabular component during primary THA. Surgical approach other than direct anterior was also independently associated with malpositioned cups.Conclusions: Surgeons should therefore take special care during placement of the acetabular component in patients with AD. (C) 2016 Elsevier Inc. All rights reserved.

Background The EQ-5D is a generic health survey that can be used to compare improvement across different interventions, measure changes in health-related quality of life over time, or to explore cost-effectiveness among treatments, hospitals, or providers. The original EQ-5D survey has three response options for each of five health dimensions; however, with so few response options, ceiling and floor effects are problematic in some populations. A new version, called the EQ-5D-5L, was developed, which gives respondents five answer options (the “5L” refers to five response levels, which is in contrast to the original survey's three levels). However, the validity of this version has not, to our knowledge, been evaluated in patients undergoing total hip arthroplasty (THA). Questions/purposes The purposes of this study were (1) to characterize the redistribution of responses using the new version; (2) to describe the ceiling and floor effects in the current three-level version and identify whether the new EQ-5D-5L survey diminished these effects; and (3) to understand the convergent validity of the new version with the old and the EQ visual analog scale. Methods Both versions of the survey were administered either preoperatively or 1 to 6 years after THA, allowing at least 2 weeks between administrations. Responses to the two versions were compared to determine response redistribution properties, ceiling and floor effects, and convergent validity. Sample sizes were determined so that the study would have 90% power to detect a Spearman correlation over 0.7 when comparing the responses of the three-level survey with the five-level survey and allowing for a rate of 25% loss to followup. Results Most patients before surgery used the new responses in the majority of dimensions, whereas the patients taking the test after surgery used the new responses predominantly for the pain dimension. The five-level diminished ceiling effects in both groups by up to 30% and diminished floor effects in the pain dimension for patients taking the assessment before surgery by 14%, which was the only dimension in either patient group that had high rates of floor effects. The correlation between the surveys’ visual analog scale and response patterns was not different for the two versions of the survey in these populations. Conclusions The EQ-5D five-level survey appears able to discriminate new health states indistinguishable in the original, which may allow more sensitive measurements of change in patients undergoing THA. The five-level survey should be considered for implementation in local and national registry monitoring of health-related quality of life in patients undergoing THA.

Obesity is known to negatively impact health related quality of life (HRQoL). Although non-disease specific tools have been used to study HRQoL after THA in obese patients, these do not directly measure health utility improvements. All 435 THA patients in the current study, regardless of BMI, reported improvement in HRQoL as measured by EQ-5D, a universal, standardized, non-disease specific preference-based instrument. These data suggest obese patients value their quality of life improvement following THA as much as non-obese patients. Furthermore, the increased activity level observed following THA in obese patients suggests obese patients may also obtain non-disease specific benefits of a more active lifestyle. This information is important for future assessments of value and cost-effectiveness of THA in the obese population.

Aseptic glenoid component loosening is a common cause of total shoulder arthroplasty (TSA) failure, but early detection is difficult because pain often appears late and radiolucent lines are of uncertain significance. This study sought to answer the following questions: (1) What types of glenoid component motion may be observed during the first 3 years following implantation?; (2) Is the appearance of radiolucent lines around the glenoid component a reliable indicator of component motion?; and (3) Are clinical outcomes correlated with early glenoid component motion within the first 3 years after TSA? Eleven patients (mean age, 60.6 years) underwent TSA using a cemented, all-polyethylene glenoid component with tantalum bead implantation. Clinical outcomes (American Shoulder and Elbow Surgeons [ASES] score, visual analog scale [VAS] pain score, and range of motion) were compared pre- and postoperatively, and radiolucencies were graded according to the criteria of Lazarus et al. Patients were evaluated using radiostereometric analysis at 6 months and 1, 2, and 3 years postoperatively to measure component micromotion in translation and rotation. At a mean follow-up of 50.2 months, mean ASES score had improved from 30.3 to 81.3 ( P <.001), mean VAS pain score had improved from 8 to 1 ( P <.001), active forward flexion had improved from 109° to 155° ( P =.001), active external rotation had improved from 28° to 54° ( P =.003), and internal rotation had improved from the level of the sacrum to L3 ( P =.002). Radiolucencies were detected around none of the components at 1 year, 6 components at 2 years, and 5 components at 3 years, and these radiolucencies were mostly found around components that experienced high levels of rotational motion. [ Orthopedics. 2015; 38(10):e891–e897.]

Introduction Scyon Orthopaedics AG developed a new mode of cementless fixation of the femoral component that provides immediate and permanent anchorage by monocortical locking screws. The aim of this study was to evaluate the stability of the Scyon total hip replacement (THR) stem in-vivo. Methods A total of 15 patients, with an average age of 50 years had surgery between 2008 and 2011. Each patient received a Scyon THR. Standard questionnaires were completed at each follow-up visit for evaluation of functional outcomes. RSA, patient reported outcomes, and plain radiographic follow-up were obtained at 6 months, 1 year, 2 years, and 5 years postoperatively. Results The median ± standard error (SE) stem subsidence (negative y-translation) was 0.07 ± 0.07 mm at 1 year, 0.05 ± 0.04 mm at 2 years and 0.04 ± 0.13 mm at 5 years. The median ± SE stem rotation (y-rotation) was 0.1 ± 0.21 degrees at 1 year, 0.51 ± 0.31 degrees at 2 years and 0.60 ± 0.37 degrees at 5 years. Plain radiographs showed bone on-growth onto medial aspect of the stem. Median HHS improved from 55 preoperatively to 93 at 1 year and 97 at 5 years. The median UCLA Activity Score improved from 4 preoperatively to 6 at 1 year and 5 years. Conclusions RSA results indicate that the Scyon stem with its 5 monocortical locking screws is stable at 5 years. Immediate surgical fixation of the stem and bony on-growth onto the femoral component may ultimately decrease the rate of aseptic stem loosening in these THR patients.