Custom total knee arthroplasty with personalised alignment showed better 2-year functional outcome compared to off-the-shelf arthroplasty.

PURPOSE: Customised individually made (CIM) total knee arthroplasty (TKA) with personalised alignment is relatively new and evidence is limited. The aim of this study was to compare patient-reported outcome measures between CIM and off-the-shelf (OTS) TKA patients in a matched-pair analysis with a 2-year follow-up. METHODS: In this single-centre, prospective cohort study, propensity score matching was performed on 51 CIM and 51 OTS TKA. Data were measured at baseline, at 4 months, 1 and 2 years and included the Forgotten Joint Score (FJS-12), the High Activity Arthroplasty Score (HAAS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the EQ-5D-3L, the EQ-Visual Analogue Scale, satisfaction, overall knee improvement, willingness to undergo the surgery again and the Knee Society Score. RESULTS: At 2 years follow-up, the FJS-12 (77 vs. 67, p = .058), HAAS (13 vs. 11, p < .001), KOOS daily living (92 vs. 86, p = .029), KOOS sport (76 vs. 65, p = .019), KOOS quality of life (81 vs. 71, p = .028) and the EQ-5D (.95 vs. .90, p = .030) were higher for CIM TKA compared to OTS TKA. Satisfaction rate was 92% for CIM TKA and 84% for OTS TKA (p = .357). Most patients reported an improvement in the overall knee state (94% CIM and 90% OTS, p = .487) and almost all patients would undergo the surgery again (96% CIM and 98% OTS, p = .999). CONCLUSION: The current study found that CIM TKA patients had better functional outcomes at 2 years. Patient satisfaction was high and not statistically significantly different from OTS TKA patients. LEVEL OF EVIDENCE: Level II prospective cohort study.

High Expectations Among Patients Who Have Undergone TKA Do Not Correlate With Satisfaction.

BACKGROUND: One of five patients is dissatisfied with the outcome of TKA. With the increasing number of TKAs, this affects many patients. It has been suggested that high expectations may influence satisfaction, but the relationship between preoperative patient expectations and postoperative patient satisfaction remains poorly understood. QUESTIONS/PURPOSES: (1) Are preoperative patient expectations correlated with postoperative satisfaction? (2) Are expectations correlated with patient characteristics or patient-reported outcome measures (PROMs)? (3) Is satisfaction correlated with patient characteristics or PROMs? (4) Do patients report specific items as more relevant to their expectations? METHODS: This was a single-center, observational, retrospective, comparative study involving patients who underwent TKA. Between December 2020 and June 2022, three senior surgeons performed 306 TKAs. Of these, 76% (234) had the preoperative PROMs required for this study, and of these, 82% (193) had completed PROMs at the 12-month follow-up interval and were analyzed. Of the 193 included patients, 53% (102) were women; the mean age was 68 ± 9 years. Data were collected at baseline, 4 months, and 12 months. Twelve months of follow-up has been shown to be adequate in studies with PROMs. Patient expectations were measured using the validated Hospital for Special Surgery Knee Replacement Expectation Survey on a scale from 0 to 100, with higher scores indicating higher expectations. We also assessed patient satisfaction, the Knee injury and Osteoarthritis Outcome Score, Forgotten Joint Score, High-Activity Arthroplasty Score, EQ-5D-3L, and the objective Knee Society Score. Bivariate linear correlations were analyzed using the Pearson or Spearman test. RESULTS: Preoperative patient expectations did not correlate with postoperative satisfaction. The mean Hospital for Special Surgery Knee Replacement Expectation Survey score was 82 ±16 points and did not correlate with satisfaction at either 4 months (r = -0.061; p = 0.42) or 12 months (r = -0.126; p = 0.11). Expectations did not correlate with patient characteristics or any of the preoperative or postoperative PROMs or the Knee Society Score. Patient satisfaction was 88% (158 of 179) at 4 months and 83% (160 of 193) at 12 months and did not correlate with patient characteristics or any of the preoperative PROMs or Knee Society Score. Patient satisfaction was medium to strongly correlated with postoperative PROMs and Knee Society Score. The Hospital for Special Surgery Knee Replacement Expectation Survey items with the most frequent expected improvement were "ability to walk" (99% [192 of 193]), "go downstairs" (99% [191 of 192]), and "go upstairs" (99% [192 of 193]). CONCLUSION: Preoperative expectations were not correlated with postoperative satisfaction or PROMs. Surgeons should be aware that patients have high expectations. However, these expectations appear to be less relevant in determining postoperative satisfaction. LEVEL OF EVIDENCE: Level III, therapeutic study.

Comparison of Responsiveness of Patient-Reported Outcome Measures After Total Knee Arthroplasty.

BACKGROUND: The aim of this study was to evaluate the responsiveness of different patient-reported outcome measures in patients with primary total knee arthroplasty (TKA). METHODS: In this prospective observational study, we assessed patients with TKA before the surgery, after 4 months, after 1 year, and after 2 years. Measures were the objective Knee Society Score (KSS) and the following patient-reported outcome measures: Knee injury and Osteoarthritis Outcome Score (KOOS), KOOS-12, Forgotten Joint Score (FJS-12), High-Activity Arthroplasty Score, and EQ-5D-3L. Responsiveness was determined by effect size (ES), standardized response mean (SRM), area under the receiver operating characteristics curve, floor and ceiling effects, and hypothesis testing. RESULTS: We analyzed data from 309 TKAs (272 patients, 56% female). The ES and SRM for the change in KSS, KOOS, KOOS-12, FJS-12, and EQ-5D-3L from baseline to each follow-up were large (>0.8). The largest responsiveness from baseline to follow-up was found for the KSS, KOOS/KOOS-12 quality of life, KOOS-12 summary, KOOS-12 pain, and FJS-12 (2.0 > ES <3.9, 1.4 > SRM <2.4). The area under the curve from baseline to each follow-up was ≥0.7 for KOOS, KOOS-12, and FJS-12 (range 0.71 to 0.95) and <0.7 for KSS and EQ-5D-3L (range 0.65 to 0.74). We found floor or ceiling effects in the KOOS, KOOS-12, and EQ-5D-3L, but not in the KSS, FJS-12, and High-Activity Arthroplasty Score. CONCLUSIONS: Our study demonstrated that responsiveness differed between the various measures. The KOOS-12 and FJS-12 showed the greatest internal and external responsiveness, although ceiling effects occurred in the KOOS-12.

Satisfaction after total knee arthroplasty: a prospective matched-pair analysis of patients with customised individually made and off-the-shelf implants.

PURPOSE: Customised individually made (CIM) total knee arthroplasty (TKA) was introduced to potentially improve patient satisfaction and other patient-reported outcome measures (PROMs). The purpose of this study was to compare PROMs, especially patient satisfaction, of patients with CIM and OTS TKA in a matched-pair analysis with a 2-year follow-up. METHODS: This is a prospective cohort study with a propensity score matching of 85 CIM and 85 off-the-shelf (OTS) TKA. Follow-up was at 4 months, 1 year and 2 years. The primary outcome was patient satisfaction. Secondary outcomes were as follows: overall improvement, willingness to undergo the surgery again, Knee injury and Osteoarthritis Outcome Score (KOOS), Forgotten Joint Score (FJS-12), High-Activity Arthroplasty Score (HAAS), EQ-5D-3L, EQ-VAS, Knee Society Score (KSS) and surgeon satisfaction. RESULTS: Patient satisfaction ranged from 86 to 90% and did not differ between CIM and OTS TKA. The EQ-VAS after 4 months and the HAAS after 1 year and 2 years were higher for CIM TKA. KOOS, FJS-12 and EQ-5D-3L were not different at follow-up. The changes in KOOS symptoms, pain and daily living were higher for OTS TKA. The KSS was higher for patients with CIM TKA. Surgeon satisfaction was high throughout both groups. Patients who were satisfied after 2 years did not differ preoperatively from those who were not satisfied. Postoperatively, all PROMs were better for satisfied patients. Patient satisfaction was not correlated with patient characteristics, implant or preoperative PROMs, and medium to strongly correlated with postoperative PROMs. CONCLUSION: Patient satisfaction was high with no differences between patients with CIM and OTS TKA. Both implant systems improved function, pain and health-related quality of life. Patients with CIM TKA showed superior results in demanding activities as measured by the HAAS. LEVEL OF EVIDENCE: II, prospective cohort study.

No difference in patient-reported satisfaction after 12 months between customised individually made and off-the-shelf total knee arthroplasty.

PURPOSE: A subset of patients is usually not satisfied after a total knee arthroplasty (TKA). Customised individually made (CIM) TKA are deemed to overcome drawbacks of classical off-the-shelf (OTS) TKA, but evidence is still sparse. The aim of this study was to compare satisfaction of patients with CIM and OTS TKA. METHODS: This prospective cohort study compared clinical and patient-reported outcome measures (PROM) between patients with CIM and OTS TKA. The primary outcome was patient satisfaction after 12 months. Secondary outcomes were the Knee Society Score (KSS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Forgotten Joint Score (FJS-12) and the EQ-5D-3L after 4 and 12 months. RESULTS: Data were analysed from 74 CIM TKA and 169 OTS TKA between January 2017 and September 2020. Patients with CIM TKA were slightly younger, more often male, had a lower body mass index, a lower KSS and partially higher preoperative PROMs. Patient satisfaction after 12 months was high and comparable (CIM 87%, OTS 89%). All PROMs improved for both groups (p < 0.001) and did not differ after 12 months (p > 0.063). The majority of patients improved above the minimal important difference (range 65 to 89%) and reported a clear overall improvement (CIM 86%, OTS 87%). The postoperative KSS, notably regarding knee stability, was higher for CIM TKA (p < 0.001). CONCLUSION: No difference was found in patient satisfaction between CIM and OTS TKA after 12 months. In both groups, patient satisfaction was high and PROMs improved considerably. LEVEL OF EVIDENCE: II, prospective cohort study.

Relevant changes of leg alignment after customised individually made bicompartmental knee arthroplasty due to overstuffing.

PURPOSE: The purpose of this study is to analyse the change in knee alignment after customised individually made (CIM) bicompartmental knee arthroplasty (BKA) and the subsequent consequences for patellar tracking. METHODS: Medical records of 23 patients who received 26 CIM BKA (ConforMIS iDuo G2) at our clinic between November 2015 and July 2018 were reviewed. The objective part of the Knee Society Score (KSS), the hip-knee-ankle angle (HKA), the tibial mechanical angle (TMA) and femoral mechanical angle (FMA) were recorded preoperative and four months postoperative. Leg alignment was classified as neutral (HKA = 180° ± 3°), varus (HKA < 177°) or valgus (HKA > 183°). Furthermore, patellar tracking was determined on skyline view radiographs and adverse events were recorded. Implant survival rate was determined with the Kaplan-Meier method. Patient-reported outcome measures (PROMs) were pain, satisfaction, overall improvement and if the patient would undergo the surgery again. RESULTS: The mean KSS improved from 61 points preoperative [standard deviation (SD) 14] to 90 points postoperative (SD 7, p < 0.001). The mean change for HKA was 6.3° (SD 3.5), for TMA 1.5° (SD 1.2) and for FMA 3.8° (SD 2.3). Postoperative leg alignment was neutral in 13 CIM BKA (50%), varus in two (8%) and valgus in 11 (42%) and patella tracking was central in 19 CIM BKA (73%) and lateral in seven (27%), respectively. Adverse events occurred in five CIM BKA: three patients required a patella resurfacing and one patient with bilateral CIM BKA needed a revision to a total knee arthroplasty. Implant survival rate was 92.3% at a follow-up of 3.2 years (SD 0.8). PROMs for CIM BKA without revision surgery were available at a mean follow-up of 3.2 years (SD 0.8). Mean pain with level walking decreased to 0.8 points (SD 1.4, p < 0.001) and mean pain with stairs or inclines to 1.6 points (SD 1.3, p < 0.001). Patient satisfaction was very satisfied or satisfied (78%), neutral (17%) or unsatisfied (4%). Overall improvement was much better or considerably better for 91% of all patients; 87% would undergo the surgery again. CONCLUSION: A relevant change of the leg axis away from the treated femorotibial compartment due to overstuffing was observed. Although, neutral leg alignment was not restored in every case, clinical and patient-reported outcomes improved significantly. Further studies with long-term clinical and patient-reported outcomes are required to evaluate whether patients with bicompartmental knee osteoarthritis benefit from CIM BKA. LEVEL OF EVIDENCE: IV, case series.

The German version of the High-Activity Arthroplasty Score is valid and reliable for patients after total knee arthroplasty.

PURPOSE: The indications for a total knee arthroplasty (TKA) broadened to younger and more active patients. The High-Activity Arthroplasty Score (HAAS) is a self-administered instrument focussing on the wider range of functional abilities of more active patients. The HAAS was developed in English and is not available in German yet. This study aims to translate, cross-cultural adapt and assess the psychometric properties of the German HAAS in patients 12 months after primary TKA. METHODS: After forward and backward translation, we examined the final version regarding its psychometric properties in patients 12 months after primary TKA. The HAAS was sent out to 70 patients together with routine questionnaires comprising the Knee injury and Osteoarthritis Outcome Score (KOOS), the Forgotten Joint Score (FJS-12), the EuroQol (EQ-5D-3L) and 2 numerical pain rating scales. Acceptability, reliability, responsiveness, content and construct validity as well as floor and ceiling effects were evaluated. RESULTS: Fifty-two patients were recruited. The HAAS was well accepted with a mean time to completion of 2.4 min. Cronbach's alpha for internal consistency was 0.749, test-retest reliability was excellent with an Intraclass Correlation Coefficient (ICC) of 0.961. The smallest detectable change was 1.5. Good content validity was confirmed. A strong correlation was found between the HAAS and KOOS sport (r = 0.661) and a medium correlation for all other KOOS subscales (r = 0.324 to 0.453), the FJS-12 (r = 0.425), the EQ-5D-3L (r = 0.427) and pain (r = - 0.439 to - 0.308). The HAAS showed no floor and ceiling effects. CONCLUSIONS: The German version of the HAAS provides good validity and reliability. It can be easily self-administered and is recommended to capture high-intensity activities in patients after TKA. LEVEL OF EVIDENCE: Diagnostic study, Level I.

Customised, individually made total knee arthroplasty shows promising 1-year clinical and patient reported outcomes.

INTRODUCTION: Customised individually made (CIM) implants for total knee arthroplasty (TKA) were introduced about 10 years ago. These implants aim to reduce the risk of prosthesis-related issues resulting from anthropometric differences between different knees. The purpose of this study was to analyse the short-term clinical outcome and patient reported outcome measures (PROMs) of a specific CIM implant, the ORIGIN® knee replacement system (Symbios, Yverdon-les-Bains, Switzerland), which was introduced in 2018. MATERIALS AND METHODS: This is a prospective cohort study of patients undergoing primary posterior-stabilised (PS) CIM TKA using the specific ORIGIN® knee replacement system, (Symbios, Yverdon-les-Bains, Switzerland). TKAs were performed from February 2019 to October 2020. Data was collected preoperatively and postoperatively at 4 and 12 months. Outcome measures included the objective part of the Knee Society Score (KSS) with the range of motion (ROM) and the following PROMs: the Knee injury and Osteoarthritis Outcome Score (KOOS), the Forgotten Joint Score (FJS-12), the EuroQol, five dimensions, three levels (EQ-5D-3L) with the EuroQol visual analogue scale (EQ-VAS) and patient satisfaction. Differences in pre- to preoperative data were assessed with paired sample t tests. A p value < 0.05 was considered significant. RESULTS: Twenty-five CIM TKA (20 patients, 8 female) were included. The mean age at surgery was 66 years (SD, 6.9). At 4 and 12 months, significant improvements in the KSS (p < 0.001), the ROM (p < 0.001), all KOOS subscales (p < 0.001), the FJS (p < 0.001) and the EQ-5D-3L (p < 0.026) were found. Satisfaction rate was 91% and 88% at 4 and 12 months, respectively. Intraoperative complications did not occur and no revision surgeries were undertaken. CONCLUSIONS: The present study demonstrated significant improvements in the KSS and specific PROMs 1 year after CIM TKA. This study suggests that CIM TKA is a safe and suitable option, which can yield good clinical outcome and PROMs at least during short-term follow-up.

The landscape of pediatric Diamond-Blackfan anemia in Switzerland: genotype and phenotype characteristics.

Diamond-Blackfan anemia (DBA) is caused mainly by genetic mutations in large (RPL) or small ribosomal subunit genes (RPS) and presents with macrocytic anemia and congenital malformations. Clinical differences between genotypes are insufficiently understood. The aim of this study was to assess clinical features, treatment strategies, and genotypes in the Swiss pediatric DBA population. We retrospectively reviewed medical charts of pediatric patients with DBA in Switzerland and stratified patients by RPL versus RPS mutations. We report 17 DBA patients in Switzerland who were all genetically investigated. In our cohort, patients showed a wide spectrum of clinical presentations and treatment needs. We found a high proportion of physical malformations (77%) including lower limb (17%) and anorectal (12%) malformations. The two patients with anorectal malformations presented both with antepositioning of the anus needing surgery within the first 15 months of life. One of these patients had sphincteric dysfunction, the other coccygeal agenesis. We found that included patients with an RPL mutation more frequently tended to have physical malformations and a milder anemia compared to patients with an RPS mutation (median hemoglobin at diagnosis 76 g/l versus 22 g/l).Conclusion: We illustrate the wide clinical and genetic spectrum of DBA in Switzerland. Our findings highlight the need to take this diagnosis into consideration in patients with severe anemia but also in patients with mild anemia where malformations are present. Lower limb and anorectal malformation extend the spectrum of DBA-associated malformations. What is Known? • There is a large variation in the phenotype of Diamond-Blackfan Anemia (DBA) and diversity of genetic mutations. • Malformation of the upper limbs, head and face, heart, and genitourinary system is frequently identified. What is New? • Patients with lower limb and anorectal malformations were repetitively found in our cohort enlarging the clinical spectrum of malformations. • We show two patients of the same family with a DBA-like condition where the same RPL17 variant was identified.

ACL Study Group survey reveals the evolution of anterior cruciate ligament reconstruction graft choice over the past three decades.

PURPOSE: Anterior cruciate ligament reconstruction (ACLR) aims to restore knee function and stability, allowing patients to return to the activities they enjoy and minimize further injury to the meniscus and cartilage and their ultimate progression to osteoarthritis. This study aims to present the evolution of graft choice over the last three decades according to members of the ACL Study Group (SG). METHODS: Prior to the January 2020 ACL SG biannual meeting, a survey was administered consisting of 87 questions and 16 categories, including ACLR graft choice. A similar questionnaire has been administered prior to each meeting and survey results from the past 14 meetings (1992 through 2020, excluding 1994) are included in this work. Survey responses are reported as frequencies in percentages to quantify changes in practice over the surgery period. RESULTS: In 1992, the most frequent graft choice for primary ACLR was bone-patellar tendon-bone (BTB) autograft, at nearly 90%. Hamstring tendon (HT) autografts have increased in popularity, currently over 50%, followed by just under 40% BTB autograft. Recently, quadriceps tendon (QT) autograft has increased in popularity since 2014. CONCLUSION: Autograft (HT, BTB, QT) is an overwhelming favorite for primary ACLR over allograft. The preference for HT autograft increased over the study period relative to BTB autograft, with QT autograft gaining in popularity in recent years. Graft selection should be individualized for each patient and understanding the global trends in graft choice can help orthopaedic surgeons discuss graft options with their patients and determine the appropriate graft for each case. LEVEL OF EVIDENCE: Level V, Expert Opinion.

Midterm Follow-Up and Assessment of Cartilage Thickness by Arthro-Magnetic Resonance Imaging After Arthroscopic Cam Resection, Labral Repair, and Rim Trimming Without Labral Detachment.

PURPOSE: To evaluate the clinical and radiological outcome, sum of acetabular and femoral cartilage thickness, and rate of failure in the midterm after arthroscopic treatment of femoroacetabular impingement (FAI) syndrome with femoral osteoplasty, labral repair, and rim trimming without labral detachment. METHODS: This retrospective case series included patients with FAI syndrome who had undergone hip arthroscopy from January 2009 to December 2010 by a single surgeon, with a minimum follow-up of 55 months. Data from patients who had undergone arthroscopic hip procedures with labral repair, rim trimming, and femoral osteoplasty were analyzed pre- and postoperatively. Clinical outcome (nonarthritic hip score [NAHS], Short Form 36 [SF-36]), range of motion, progression of osteoarthritis (Tönnis grade), radiological parameters (α angle, lateral center-edge angle [LCEA], Tönnis angle), femoral and acetabular cartilage thickness (using magnetic resonance imaging [MRI]), and intraoperative findings were evaluated. RESULTS: Of 148 hip arthroscopies performed, 97 included rim trimming, labral refixation, and femoral osteoplasty. Ten cases were lost to follow-up, leaving 87 hips. Arthroscopic revision was performed on 4 hips and total hip replacement on 4 hips, and 1 hip underwent both arthroscopic revision and total hip replacement. Excluding these 9 cases of revision, for which follow-up was not possible (retrospective study), the remaining 78 hips were followed up for a minimum of 55 months (77 ± 11.4, mean ± SD; range 55 to 124). Mean NAHS (65 to 88, P < .001), SF-36 physical subscale (65 to 85, P < .001), and the numerical pain rating scale (NRS) (5 to 1, P < .001) improved significantly. Outcome scores of minimal clinical importance (NAHS) were achieved in 67.6% of the patients. Mean range of movement improved significantly in flexion (109 to 122, P < .001) and internal rotation (10 to 22.7, P < .001). NAHS was positively associated with flexion of the hip postoperatively (r = 0.307, P = .011). In 16 cases, microfracture was performed (15 acetabular and 1 femoral). Preoperative α angles (anteroposterior and modified Dunn) were significantly higher in this cohort (P < .001, 95% confidence interval 8.9 to 25.2, P = .001). Twenty hips (28 %) progressed to worse Tönnis grades. Initial Tönnis grades were grade 0, 38; grade 1, 48; grade 2, 8. Pre- or postoperative Tönnis grades did not show any correlation with pre- or postoperative NAHS and NRS. MRI measurements at the latest follow-up (69 patients) of the femoral and acetabular cartilage thickness did not reveal any significant reduction at the 12 o'clock position. CONCLUSION: Arthroscopic cam resection, rim trimming, and labral repair without detachment of the labrum provides good or excellent outcome in 77.1% of hips based on NAHS in the midterm. Higher range of motion in flexion is associated with higher NAHS postoperatively. Arthroscopic cam resection, rim trimming and labral repair without detachment of the labrum is a successful method for the treatment of FAI syndrome in the midterm. LEVEL OF EVIDENCE: IV, retrospective case series.

Comparison of Human Articular Cartilage Tissue and Chondrocytes Isolated from Peripheral versus Central Regions of Traumatic Lesions.

OBJECTIVE: Cellular and molecular events occurring in cartilage regions close to injury are poorly investigated, but can possibly compromise the outcome of cell-based cartilage repair. In this study, key functional properties were assessed for cartilage biopsies collected from the central part of traumatic joint lesions (central) and from regions surrounding the defect (peripheral). These properties were then correlated with the quality of the initial cartilage biopsy and the inflammatory state of the joint. DESIGN: Cartilage samples were collected from knee joints of 42 patients with traumatic knee injuries and analyzed for cell phenotype (by reverse transcriptas-polymerase chain reaction), histological quality, cellularity, cell viability, proliferation capacity, and post-expansion chondrogenic capacity of chondrocytes (in pellet culture). Synovium was also harvested and analyzed for the expression of inflammatory cytokines. RESULTS: Cartilage quality and post-expansion chondrogenic capacity were higher in peripheral versus central samples. Differences between these 2 parameters were more pronounced in joints with high inflammatory features characterized by >100-fold difference in the mRNA levels of IL6 and IL8 in the corresponding synovium. Peripheral chondrocytes isolated from good- versus bad-quality biopsies expressed higher levels of collagen II/I and aggrecan/versican and lower levels of MMP13 and ADAMTS5. They also exhibited reduced proliferation and enhanced cartilage-forming capacity. CONCLUSIONS: Chondrocytes at the periphery of traumatic lesions better maintain properties of healthy cartilage compared to those isolated from the center, even when derived from bad-quality tissues harvested from highly inflamed joints. Future studies are necessary to investigate the change of functional properties of peripheral chondrocytes over time.

Patient-reported outcome measures (PROMs) following knee arthroplasty: a prospective cohort study protocol.

INTRODUCTION: To evaluate the quality of clinical practice, patient-reported outcome measures (PROMs) are important as certain questions could only be answered by the patient himself. PROMs help to get a better understanding what is meaningful to a patient and directly affects daily functioning. To move beyond traditional measures, we are interested in what matters to patients and developed this project. The aim of this article is to provide the protocol for our study collecting PROMs in daily medical practice from patients who undergo knee arthroplasty. METHODS AND ANALYSIS: This study is a single-site, observational, prospective cohort study. We will recruit patients scheduled for a knee arthroplasty in our medical office, situated in a private clinic. After signed informed consent, patients complete self-reported questionnaires before the surgery, after 4 months, 1 year, 2 years, 3 years, 4 years and 5 years. We will use the following PROMs: Knee injury and Osteoarthritis Outcome Score, Forgotten Joint Score, EuroQol five dimensions and satisfaction. Additionally, the surgeon will complete the objective Knee Society Score. Administration of the questionnaires will be electronically or paper-based. We will assess differences between preoperative and postoperative data with paired t-test for continuous variables and Wilcoxon signed-rank test for categorical variables. To assess subgroup differences, we will use unpaired t-test for continuous variables and Mann-Whitney U test for categorical variables. To assess possible presence of bias, we will conduct sensitivity analyses. ETHICS AND DISSEMINATION: The study has been reviewed and approved by the local ethics committee in Basel, Switzerland. Written informed consent will be obtained from all patients. We will disseminate the results of the study through peer-reviewed journals, national and international conference presentations and presentations to relevant stakeholders through appropriate channels.

Functional Interviewing Was Associated With Improved Agreement Among Expert Psychiatrists in Estimating Claimant Work Capacity: A Secondary Data Analysis of Real-Life Work Disability Evaluations.

OBJECTIVE: Functional evaluations establish functional and work (in-)capacities in the context of disability assessments and are increasingly recommended as a modern technique for work disability assessments. The RELY (Reliable disability EvaLuation in psychiatrY)-studies introduced semi-structured functional interviews in real-life assessments of claimants with mental disorders for evaluating their self-perceived health-related limitations and for investigating the reproducibility of work capacity (WC) estimates. Functional interviews elicit claimants' self-perceptions about their work-related limitations and capacities in the labour market. This secondary data analysis explored the coverage of work-related key topics in these interviews and investigated whether interviews with high coverage (versus low coverage) of work-related topics resulted in better reproducibility of WC estimates among experts. METHODS: Thirty video-taped RELY-assessments underwent a content analysis along a predefined framework for functional interviewing, including the claimant's self-perceived work limitations and work-related health complaints as centrepieces of functional interviewing. Following transcription, interviews were segmented into coding units. Coding units were allocated to the five steps with 19 key topics of the framework. Enquiry into key topics was ascertained by summing the functional coding units per key topic. Median split grouped the interviews into high and low coverage of functional topics and compared them for inter-rater reliability (intraclass correlation coefficient, ICC) and inter-rater agreement (standard error of measurement, SEM). RESULTS: Interviews were broken down in 40,010 coding units, 31% of which addressed functional topics. Enquiries in self-perceived work limitations and work-related health complaints were sparse (coding units medianpsychiatrist between 0 and 1.5, medianpatients between 0 and 9.5). High coverage interviews enquired on more functional topics (68% vs. 42%, chi2(1, N = 38) = 5.32, p = 0.021) and in more depth (36% vs. 16% of functional coding units, chi2(1, N = 1,314) = 141.15, p < 0.001). Interviews with higher functional coverage reached significantly higher inter-rater agreement in WC ratings among experts (mean difference in SEM, low-high coverage, 7.5% WC, 95% CI 0.2 to 15.1%WC). Inter-rater reliability was low in both groups (ICC, 0.38 versus 0.40). CONCLUSIONS: Content analysis showed little enquiry by experts on claimants' self-perceived activity limitations and work-related capacity. The association between interviews with higher functional coverage and better expert agreement on the claimants' remaining WC requires confirmation in prospective studies.

Ultrasound of the elbow with emphasis on the sonoanatomy of the distal biceps tendon and its importance for the surgical treatment of tendon lesions.

Degenerative or traumatic ruptures of the distal biceps tendon are less common than proximal lesions. Distal lesions lead to a significant loss of function with usually considerable discomfort for patients. Therefore, precise diagnostics using operator-dependent high-resolution musculoskeletal ultrasound with illustration of the extent of the affected tendon lesion are important for optimizing patient management. In this article, we discuss the precise high-resolution musculoskeletal ultrasound and sonoanatomy of the distal biceps tendon and emphasize its importance for the surgical treatment of tendon lesions. In this review and pictorial essay, we first focus on the description of the precise anatomy and ultrasound anatomy of this clinically important region. Furthermore, we highlight different ultrasound scanning techniques for the correct assessment of the distal biceps tendon. Various approaches for optimal sonographic assessment of the distal biceps tendon have been suggested in the literature: the anterior approach, the lateral access, the medial access and the posterior approach. In the second part of the article, we focus on the evaluation of surgical repair techniques of distal biceps tendon lesions considering the extent of the rupture zone of the distal biceps tendon based on the ultrasound findings. Surgical techniques are explained from the orthopedic surgical point of view.Degenerative or traumatic ruptures of the distal biceps tendon are less common than proximal lesions. Distal lesions lead to a significant loss of function with usually considerable discomfort for patients. Therefore, precise diagnostics using operator-dependent high-resolution musculoskeletal ultrasound with illustration of the extent of the affected tendon lesion are important for optimizing patient management. In this article, we discuss the precise high-resolution musculoskeletal ultrasound and sonoanatomy of the distal biceps tendon and emphasize its importance for the surgical treatment of tendon lesions. In this review and pictorial essay, we first focus on the description of the precise anatomy and ultrasound anatomy of this clinically important region. Furthermore, we highlight different ultrasound scanning techniques for the correct assessment of the distal biceps tendon. Various approaches for optimal sonographic assessment of the distal biceps tendon have been suggested in the literature: the anterior approach, the lateral access, the medial access and the posterior approach. In the second part of the article, we focus on the evaluation of surgical repair techniques of distal biceps tendon lesions considering the extent of the rupture zone of the distal biceps tendon based on the ultrasound findings. Surgical techniques are explained from the orthopedic surgical point of view.

The reproducibility of psychiatric evaluations of work disability: two reliability and agreement studies.

BACKGROUND: Expert psychiatrists conducting work disability evaluations often disagree on work capacity (WC) when assessing the same patient. More structured and standardised evaluations focusing on function could improve agreement. The RELY studies aimed to establish the inter-rater reproducibility (reliability and agreement) of 'functional evaluations' in patients with mental disorders applying for disability benefits and to compare the effect of limited versus intensive expert training on reproducibility. METHODS: We performed two multi-centre reproducibility studies on standardised functional WC evaluation (RELY 1 and 2). Trained psychiatrists interviewed 30 and 40 patients respectively and determined WC using the Instrument for Functional Assessment in Psychiatry (IFAP). Three psychiatrists per patient estimated WC from videotaped evaluations. We analysed reliability (intraclass correlation coefficients [ICC]) and agreement ('standard error of measurement' [SEM] and proportions of comparisons within prespecified limits) between expert evaluations of WC. Our primary outcome was WC in alternative work (WCalternative.work), 100-0%. Secondary outcomes were WC in last job (WClast.job), 100-0%; patients' perceived fairness of the evaluation, 10-0, higher is better; usefulness to psychiatrists. RESULTS: Inter-rater reliability for WCalternative.work was fair in RELY 1 (ICC 0.43; 95%CI 0.22-0.60) and RELY 2 (ICC 0.44; 0.25-0.59). Agreement was low in both studies, the 'standard error of measurement' for WCalternative.work was 24.6 percentage points (20.9-28.4) and 19.4 (16.9-22.0) respectively. Using a 'maximum acceptable difference' of 25 percentage points WCalternative.work between two experts, 61.6% of comparisons in RELY 1, and 73.6% of comparisons in RELY 2 fell within these limits. Post-hoc secondary analysis for RELY 2 versus RELY 1 showed a significant change in SEMalternative.work (- 5.2 percentage points WCalternative.work [95%CI - 9.7 to - 0.6]), and in the proportions on the differences ≤ 25 percentage points WCalternative.work between two experts (p = 0.008). Patients perceived the functional evaluation as fair (RELY 1: mean 8.0; RELY 2: 9.4), psychiatrists as useful. CONCLUSIONS: Evidence from non-randomised studies suggests that intensive training in functional evaluation may increase agreement on WC between experts, but fell short to reach stakeholders' expectations. It did not alter reliability. Isolated efforts in training psychiatrists may not suffice to reach the expected level of agreement. A societal discussion about achievable goals and readiness to consider procedural changes in WC evaluations may deserve considerations.

Opioids for Chronic Noncancer Pain: A Systematic Review and Meta-analysis.

Importance: Harms and benefits of opioids for chronic noncancer pain remain unclear. Objective: To systematically review randomized clinical trials (RCTs) of opioids for chronic noncancer pain. Data Sources and Study Selection: The databases of CENTRAL, CINAHL, EMBASE, MEDLINE, AMED, and PsycINFO were searched from inception to April 2018 for RCTs of opioids for chronic noncancer pain vs any nonopioid control. Data Extraction and Synthesis: Paired reviewers independently extracted data. The analyses used random-effects models and the Grading of Recommendations Assessment, Development and Evaluation to rate the quality of the evidence. Main Outcomes and Measures: The primary outcomes were pain intensity (score range, 0-10 cm on a visual analog scale for pain; lower is better and the minimally important difference [MID] is 1 cm), physical functioning (score range, 0-100 points on the 36-item Short Form physical component score [SF-36 PCS]; higher is better and the MID is 5 points), and incidence of vomiting. Results: Ninety-six RCTs including 26 169 participants (61% female; median age, 58 years [interquartile range, 51-61 years]) were included. Of the included studies, there were 25 trials of neuropathic pain, 32 trials of nociceptive pain, 33 trials of central sensitization (pain present in the absence of tissue damage), and 6 trials of mixed types of pain. Compared with placebo, opioid use was associated with reduced pain (weighted mean difference [WMD], -0.69 cm [95% CI, -0.82 to -0.56 cm] on a 10-cm visual analog scale for pain; modeled risk difference for achieving the MID, 11.9% [95% CI, 9.7% to 14.1%]), improved physical functioning (WMD, 2.04 points [95% CI, 1.41 to 2.68 points] on the 100-point SF-36 PCS; modeled risk difference for achieving the MID, 8.5% [95% CI, 5.9% to 11.2%]), and increased vomiting (5.9% with opioids vs 2.3% with placebo for trials that excluded patients with adverse events during a run-in period). Low- to moderate-quality evidence suggested similar associations of opioids with improvements in pain and physical functioning compared with nonsteroidal anti-inflammatory drugs (pain: WMD, -0.60 cm [95% CI, -1.54 to 0.34 cm]; physical functioning: WMD, -0.90 points [95% CI, -2.69 to 0.89 points]), tricyclic antidepressants (pain: WMD, -0.13 cm [95% CI, -0.99 to 0.74 cm]; physical functioning: WMD, -5.31 points [95% CI, -13.77 to 3.14 points]), and anticonvulsants (pain: WMD, -0.90 cm [95% CI, -1.65 to -0.14 cm]; physical functioning: WMD, 0.45 points [95% CI, -5.77 to 6.66 points]). Conclusions and Relevance: In this meta-analysis of RCTs of patients with chronic noncancer pain, evidence from high-quality studies showed that opioid use was associated with statistically significant but small improvements in pain and physical functioning, and increased risk of vomiting compared with placebo. Comparisons of opioids with nonopioid alternatives suggested that the benefit for pain and functioning may be similar, although the evidence was from studies of only low to moderate quality.

Return-to-work coordination programmes for improving return to work in workers on sick leave.

BACKGROUND: To limit long-term sick leave and associated consequences, insurers, healthcare providers and employers provide programmes to facilitate disabled people's return to work. These programmes include a variety of coordinated and individualised interventions. Despite the increasing popularity of such programmes, their benefits remain uncertain. We conducted a systematic review to determine the long-term effectiveness of return-to-work coordination programmes compared to usual practice in workers at risk for long-term disability. OBJECTIVES: To assess the effects of return-to-work coordination programmes versus usual practice for workers on sick leave or disability. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 11), MEDLINE, Embase, CINAHL and PsycINFO up to 1 November 2016. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that enrolled workers absent from work for at least four weeks and randomly assigned them to return-to-work coordination programmes or usual practice. DATA COLLECTION AND ANALYSIS: Two review authors independently screened titles, abstracts and full-text articles for study eligibility; extracted data; and assessed risk of bias from eligible trials. We contacted authors for additional data where required. We conducted random-effects meta-analyses and used the GRADE approach to rate the quality of the evidence. MAIN RESULTS: We identified 14 studies from nine countries that enrolled 12,568 workers. Eleven studies focused on musculoskeletal problems, two on mental health and one on both. Most studies (11 of 14) followed workers 12 months or longer. Risk of bias was low in 10 and high in 4 studies, but findings were not sensitive to their exclusion.We found no benefits for return-to-work coordination programmes on return-to-work outcomes.For short-term follow-up of six months, we found no effect on time to return to work (hazard ratio (HR) 1.32, 95% confidence interval (CI) 0.93 to 1.88, low-quality evidence), cumulative sickness absence (mean difference (MD) -16.18 work days per year, 95% CI -32.42 to 0.06, moderate-quality evidence), the proportion of participants at work at end of the follow-up (risk ratio (RR) 1.06, 95% CI 0.86 to 1.30, low-quality evidence) or on the proportion of participants who had ever returned to work, that is, regardless of whether they had remained at work until last follow-up (RR 0.87, 95% CI 0.63 to 1.19, very low-quality evidence).For long-term follow-up of 12 months, we found no effect on time to return to work (HR 1.25, 95% CI 0.95 to 1.66, low-quality evidence), cumulative sickness absence (MD -14.84 work days per year, 95% CI -38.56 to 8.88, low-quality evidence), the proportion of participants at work at end of the follow-up (RR 1.06, 95% CI 0.99 to 1.15, low-quality evidence) or on the proportion of participants who had ever returned to work (RR 1.03, 95% CI 0.97 to 1.09, moderate-quality evidence).For very long-term follow-up of longer than 12 months, we found no effect on time to return to work (HR 0.93, 95% CI 0.74 to 1.17, low-quality evidence), cumulative sickness absence (MD 7.00 work days per year, 95% CI -15.17 to 29.17, moderate-quality evidence), the proportion of participants at work at end of the follow-up (RR 0.94, 95% CI 0.82 to 1.07, low-quality evidence) or on the proportion of participants who had ever returned to work (RR 0.95, 95% CI 0.88 to 1.02, low-quality evidence).We found only small benefits for return-to-work coordination programmes on patient-reported outcomes. All differences were below the minimal clinically important difference (MID). AUTHORS' CONCLUSIONS: Offering return-to-work coordination programmes for workers on sick leave for at least four weeks results in no benefits when compared to usual practice. We found no significant differences for the outcomes time to return to work, cumulative sickness absence, the proportion of participants at work at end of the follow-up or the proportion of participants who had ever returned to work at short-term, long-term or very long-term follow-up. For patient-reported outcomes, we found only marginal effects below the MID. The quality of the evidence ranged from very low to moderate across all outcomes.

Use of a structured functional evaluation process for independent medical evaluations of claimants presenting with disabling mental illness: rationale and design for a multi-center reliability study.

BACKGROUND: Work capacity evaluations by independent medical experts are widely used to inform insurers whether injured or ill workers are capable of engaging in competitive employment. In many countries, evaluation processes lack a clearly structured approach, standardized instruments, and an explicit focus on claimants' functional abilities. Evaluation of subjective complaints, such as mental illness, present additional challenges in the determination of work capacity. We have therefore developed a process for functional evaluation of claimants with mental disorders which complements usual psychiatric evaluation. Here we report the design of a study to measure the reliability of our approach in determining work capacity among patients with mental illness applying for disability benefits. METHODS/DESIGN: We will conduct a multi-center reliability study, in which 20 psychiatrists trained in our functional evaluation process will assess 30 claimants presenting with mental illness for eligibility to receive disability benefits [Reliability of Functional Evaluation in Psychiatry, RELY-study]. The functional evaluation process entails a five-step structured interview and a reporting instrument (Instrument of Functional Assessment in Psychiatry [IFAP]) to document the severity of work-related functional limitations. We will videotape all evaluations which will be viewed by three psychiatrists who will independently rate claimants' functional limitations. Our primary outcome measure is the evaluation of claimant's work capacity as a percentage (0 to 100 %), and our secondary outcomes are the 12 mental functions and 13 functional capacities assessed by the IFAP-instrument. Inter-rater reliability of four psychiatric experts will be explored using multilevel models to estimate the intraclass correlation coefficient (ICC). Additional analyses include subgroups according to mental disorder, the typicality of claimants, and claimant perceived fairness of the assessment process. DISCUSSION: We hypothesize that a structured functional approach will show moderate reliability (ICC ≥ 0.6) of psychiatric evaluation of work capacity. Enrollment of actual claimants with mental disorders referred for evaluation by disability/accident insurers will increase the external validity of our findings. Finding moderate levels of reliability, we will continue with a randomized trial to test the reliability of a structured functional approach versus evaluation-as-usual.

JAK-STAT1/3-induced expression of signal sequence-encoding proopiomelanocortin mRNA in lymphocytes reduces inflammatory pain in rats.

BACKGROUND: Proopiomelanocortin (POMC)-derived beta-endorphin1-31 from immune cells can inhibit inflammatory pain. Here we investigated cytokine signaling pathways regulating POMC gene expression and beta-endorphin production in lymphocytes to augment such analgesic effects. RESULTS: Interleukin-4 dose-dependently elevated POMC mRNA expression in naïve lymph node-derived cells in vitro, as determined by real-time PCR. This effect was neutralized by janus kinase (JAK) inhibitors. Transfection of Signal Transducer and Activator of Transcription (STAT) 1/3 but not of STAT6 decoy oligonucleotides abolished interleukin-4 induced POMC gene expression. STAT3 was phosphorylated in in vitro interleukin-4 stimulated lymphocytes and in lymph nodes draining inflamed paws in vivo. Cellular beta-endorphin increased after combined stimulation with interleukin-4 and concanavalin A. Consistently, in vivo reduction of inflammatory pain by passively transferred T cells improved significantly when donor cells were pretreated with interleukin-4 plus concanavalin A. This effect was blocked by naloxone-methiodide. CONCLUSION: Interleukin-4 can amplify endogenous opioid peptide expression mediated by JAK-STAT1/3 activation in mitogen-activated lymphocytes. Transfer of these cells leads to inhibition of inflammatory pain via activation of peripheral opioid receptors.