Background & purpose. Measurement inconsistency across clinical trials is tackled by the development of a core outcome measurement set. Four core outcome domains were recommended for clinical trials in patients with non-specific LBP (nsLBP): physical functioning, pain intensity, health-related quality of life (HRQoL), and number of deaths. This study aimed to reach consensus on core instruments to measure the first three domains. Methods & Results. The Steering Committee overseeing this project selected 17 potential core instruments for physical functioning, three for pain intensity, and five for HRQoL. Evidence on their measurement properties in nsLBP was synthesized in three systematic reviews using COSMIN methodology. Researchers, clinicians, and patients (n = 208) were invited in a Delphi survey to seek consensus on which instruments to endorse as core. Consensus was a-priori set at 67% of participants agreeing on endorsing an instrument. Two Delphi rounds were run (response rates = 44% and 41%). Agreement was reached on endorsing the Oswestry Disability Index (ODI 2.1a) for physical functioning, the Numeric Rating Scale (NRS) for pain intensity, but not on other instruments. Several participants demanded to have free of charge core instruments. Taking these results into account, the steering committee formulated the following recommendations: ODI 2.1a or 24-item Roland Morris Disability Questionnaire for physical functioning, NRS for pain intensity, Short-Form 12 or 10-item PROMIS Global Health for HRQoL. Conclusion. A core outcome measurement set is available for clinical trials in patients with nsLBP. High quality clinimetric studies directly comparing recommended and not recommended instruments are required. Conflict of interest: None. Source of funding: EUROSPINE, The Spine Society of Europe

Introduction: Multiple scoring systems are available to evaluate arthritic hip pain and to assess outcome after arthroplasty. These scores focus on evaluating hip pain and function in elderly patients with degenerative joint disease. They are not specific for sports-related or mechanical hip symptoms in young people, or sensitive to change after new treatments such as arthroscopic hip surgery.

Methods: We systematically reviewed the literature since 1980, searching for systems used to measure severity of symptoms and outcome of treatment in these patients. We collected reports of performance of these systems. We then used the best of them to collect symptom scores from 200 patients, and measured the agreement of systems. We performed an item reduction process to identify the question items most associated with overall scores.

Results: Systematic review yielded 4 scoring systems which have been used to evaluate sports-related or mechanical hip symptoms: the Non-arthritic Hip Score (NHS), Hip Outcome Score (HOS), Hip disability and Osteoarthritis Outcome Score (HOOS)and a modified Harris Hip Score (mHHS). All scores are self administered and symptom related, requiring no physical examination. All but the mHHS have some evidence of reliability and validity. There is a great deal of overlap among the variables selected by the authors and agreement between the various scoring systems is surprisingly good. Most of the variability of all of the systems could be captured with ten simple questions.

Conclusion: We have developed a simple set of ten questions which capture outcome information as well as existing more complex systems. This will be useful is assessing outcome after new treatments such as hip arthroscopy in young active people.

Introduction: Randomised Controlled Trials (RCTs) of interventions to reduce the incidence of falls have used a variety of methods to define and measure outcomes. A standardised approach to defining and measuring outcomes, and a shared taxonomy of interventions is a prerequisite to interpret and disseminate the findings of studies.

Method: We agreed to focus on five areas: falls, injuries, psychological consequences, physical activity and quality of life. A systematic literature review has been performed to identify outcome definitions currently used in RCTs and is focusing on the quality of outcome measures in terms of reliability, validity and acceptability. A consensus building process is being performed using a modified nominal group technique to define a core set of outcome definitions and measures, which can then be piloted in a number of sites across Europe. Where consensus cannot be achieved, suggestions are made for future research to develop and/or appraise new methods of measurement and these will feed into future revisions of the recommendations. The taxonomy of interventions is being developed in parallel with this process.

Results: The presentation will demonstrate how varying methods of defining falls can lead to a different interpretation of trial results and suggest a range of definitions than might be included in future trials. We consider the number of falls, number of fallers, time to first fall, and fractures per fall ratios as examples.

Conclusions: An agreed and standardised set of outcome definitions and measures is important to improve the robustness of data from intervention studies, will enable comparison across studies, good quality measurement in multi-centre trials, and facilitate meta-analysis of trial results. A taxonomy of interventions facilitates comparisons between studies, helps to determine the most effective components or sub-components of interventions, and aids the decision making process of policy makers and health insurance plans.

Abstract. Background. The Forgotten Joint Score (FJS) is a 12-item patient reported outcome measurement instrument. It was developed with classical test theory, without testing assumptions such as unidimensionality (all items reflect one underlying factor), appropriate weighting of each item, no differential item function (DIF, different groups answer the same way), and monotonicity (people with higher function have higher score). We applied item response theory (IRT) to improve the validity of FJS to contemporary standards to optimise it for ongoing use. Research Questions. Does the FJS reflect one latent trait? Can an IRT model be fitted to the FJS to provide interval-scaled measurement?. Methodology. Participants undergoing primary total knee replacement provided pre-operative and post-operative (6-months) responses for FJS. An exploratory factor analysis (EFA), confirmatory factor analysis (CFA) and Mokken analysis were conducted. The data were fitted to a graded response model (GRM). Results. 1288 response patterns were analysed. EFA showed a one factor model (all 12 items load to one underlying trait). CFA demonstrated excellent model fit (X2 <0.001, Tucker Lewis Index=0.96, Comparative Fit Index=0.96). Items did not have equal weighting. The FJS demonstrated good monotonicity with no differential item functioning by sex, age, or body mass index. Conclusions. The FJS meets key validity assumptions supporting its use in clinical practice and research. The IRT-adapted FJS provides continuous measurements with greater granularity including individual measurement error. This adapted score has advantages over traditional FJS scoring, being interval scaled (using GRM) and can be retrospectively applied to existing response sets

Introduction. The heterogeneity of outcomes used in the field of lower limb lengthening surgery (LLLS) affects our ability to synthesize evidence. This hampers robust systematic reviews and treatment recommendations for clinical practice. Ultimately this reduces the impact of research for both patients and healthcare professionals. This scoping review aimed to describe the outcomes and outcome measurement instruments (OMIs) used within the field of LLLS. Method. A systematic literature search of WOS, Scopus, Embase, MEDLINE, and the Cochrane Library identified all studies reporting outcomes in children and adults after LLLS. All outcomes and OMIs were extracted verbatim. An iterative process was used to group outcome terms under standardized outcome headings categorized using the COMET Taxonomy of Outcomes. Result. Data saturation was achieved in 2020. A total of 142 studies were included between 2024-2020, reporting 2964 verbatim outcomes with 663 standardized outcome terms collapsed into 119 outcome headings (subdomains). A total of 29 patient-reported and 26 clinician-reported outcome instruments were identified. The most commonly reported outcome was “Lengthening amount”, reported in over 72% of the included studies, while “health-related quality of life” was measured in 16% and all life impact outcomes were reported in 19% of the included studies. Conclusion. A large number of peer-reviewed publications are available, demonstrating that significant resources are being devoted to research on LLLS. However, reported outcomes for people with LLLS are heterogeneous, subject to reporting bias, and vary widely in the definitions and measurement tools used to collect them. Outcomes likely to be important to patients, such as quality of life and measures of physical function, have been neglected. This scoping review identifies a need to standardize outcomes and outcome measures reported on patients recovering from lower limb lengthening surgery; this can be addressed by creating a core set of outcomes

The direct superior approach (DSA) is a modification of the posterior approach (PA) that preserves the iliotibial band and short external rotators except for the piriformis or conjoined tendon during total hip arthroplasty (THA). The objective of this study was to compare postoperative pain, early functional rehabilitation, functional outcomes, implant positioning, implant migration, and complications in patients undergoing the DSA versus PA for THA. This study included 80 patients with symptomatic hip arthritis undergoing primary THA. Patients were prospectively randomised to receive either the DSA or PA for THA, surgery was undertaken using identical implant designs in both groups, and all patients received a standardized postoperative rehabilitation programme. Predefined study outcomes were recorded by blinded observers at regular intervals for two-years after THA. Radiosteriometric analysis (RSA) was used to assess implant migration. There were no statistical differences between the DSA and PA in postoperative pain scores (p=0.312), opiate analgesia consumption (p=0.067), and time to hospital discharge (p=0.416). At two years follow-up, both groups had comparable Oxford hip scores (p=0.476); Harris hip scores (p=0.293); Hip disability and osteoarthritis outcome scores (p=0.543); University of California at Los Angeles scores (p=0.609); Western Ontario and McMaster Universities Arthritis Index (p=0.833); and European Quality of Life questionnaire with 5 dimensions scores (p=0.418). Radiographic analysis revealed no difference between the two treatment groups for overall accuracy of acetabular cup positioning (p=0.687) and femoral stem alignment (p=0.564). RSA revealed no difference in femoral component migration (p=0.145) between the groups at two years follow-up. There were no differences between patients undergoing the DSA versus PA for THA with respect to postoperative pain scores, functional rehabilitation, patient-reported outcome measurements, accuracy of implant positioning, and implant migration at two years follow-up. Both treatment groups had excellent outcomes that remained comparable at all follow-up intervals

Our understanding of pre-arthritic hip disease has evolved tremendously but challenges remain in categorizing diagnosis, which ultimately impacts choice of treatments and clinical outcomes. This study aims to report patient reported outcome measures (PROMs) comparing four different condition groups within hip preservation surgery by a group of fellowship-trained surgeons. From 2018 to 2021, 380 patients underwent hip preservation surgery at our center and were classified into five condition groups: dysplasia: 82 (21.6%), femoro-acetabular impingement (FAI): 173 (45.4%), isolated labral tear: 103 (27.1%), failed hip preservation: 20 (5.3%) and history of childhood disease/other: 2 (0.5%). International hip outcomes Tool 12 (IHOT-12), numeric pain score and patient-reported outcomes measurement information system (PROMIS) were collected pre-operatively and at 3 months and 1 year post-operatively, with 94% and 82% follow-up rate respectively. Arthroscopy (75.5%) was the most common procedure followed by peri-acetabular osteotomy (PAO) (22.4%) and surgical dislocation (2.1%). Re-operation rate were respectively 18.3% (15), 5.8% (10), 4.9% (5), 30% (6) and 0%. There were 36 re-operations in the cohort, 14 (39%) for unintended consequences of initial surgery, 10 (28%) for mal-correction leading to a repeat operation, 8 (22%) progression of arthritis, and 4 (11%) for incorrect initial diagnosis/intervention. Most common re-operations were hardware removal 31% (7 PAO, 3 surgical hip dislocation and 1 femoral de-rotational osteotomy), arthroscopy 31% (11) and arthroplasty 28% (10). All groups had significant improvements in their IHOT-12 as well as PROMIS physical and numerical pain scales, except those with failed hip preservation. Dysplasia group showed a slower recovery. Overall, this study demonstrated a clear relation between the condition groups, their respective intervention and the significant improvements in PROMs with isolated labral pathology being a valid diagnosis. Establishing tertiary referral centers for hip preservation and longer follow-up is needed to monitor the overall survivorship of these various procedures

This study evaluates patient reported outcome measurement information system (PROMIS) scores after total hip arthroplasty (THA) and total ankle arthroplasty (TAA) in matched cohorts, while simultaneously evaluating implant survivorship and 90-day hospital utilization. It is hypothesized that while both procedures would yield similar PROMIS score improvements, THA would demonstrate superior mid-term implant survivorship. Primary THA and TAA patients from 2015–2022 with minimum one-year follow-up were retrospectively reviewed. After applying exclusion criteria, 2,092 THAs and 478 TAAs were included for analysis. Demographics, pre- and post-operative patient reported outcome measures (PROMs), revision surgeries, ED visits, and re-admissions were collected. THA and TAA patients were then propensity score matched at 2:1 ratio for age, sex, race, BMI, ASA, and comorbidities, resulting in a final cohort of 844 THAs and 455 TAAs for comparison. There were similar pre-operative PROMIS Pain Interference (PI) scores between THA and TAA, with both showing improvement at six weeks. However, THA patients exhibited lower PI scores at one year (53.0 versus 54.0; p=0.009). Pre-operative PROMIS Physical Function (PF) was worse in THA patients but showed greater improvement compared to TAA patients at both six weeks (p<0.001) and one year (p<0.001). Pre-operative PROMIS depression scores were similar and improved similarly in both groups. Joint-specific PROMs (HOOS for THA and FAAM for TAA) improved in both cohorts. THA demonstrated superior survivorship free of all-cause revision at five years compared to TAA (95% versus 77%; p<0.0001). Patients undergoing THA or TAA experienced significant improvements in their general and joint-specific PROMs post-operatively. However, patients undergoing THA demonstrated higher PROMIS PI and PF scores at one-year when compared to TAA, as well as improved survivorship. Generic PRO instruments enable comparison of medical treatments in different anatomic sites to the patients overall health

Failure of osseointegration and periprosthetic joint infection (PJI) are the two main reasons of implant failure after total joint replacement (TJR). Nanofiber (NF) implant surface coating represents an alternative local drug eluting device that improves osseointegration and decreases the risk of PJI. The purpose of this study was to investigate the therapeutic efficacies of erythromycin (EM)-loaded coaxial PLGA/PCL-PVA NF coating in a rat S. aureus-infected tibia model. NF coatings with 100mg and 1000mg EM were prepared. NF without EM was included as positive control. 56 Sprague Dawley rats were divided into 4 groups. A titanium pin (1.0-mm x 8 mm) was placed into the tibia through the intercondylar notch. S. aureus (SA) was introduced by both direct injection of 10 μl broth (1 × 10. 4. CFU) into the medullary cavity and single dip of Ti pins into a similar solution prior to insertion. Rats were sacrificed at 8 and 16 weeks after surgery. The outcome measurements include μCT based quantitative osteolysis evaluation and hard tissue histology. Results: EM-NF coating (EM100 and EM1000) reduced osteolysis at 8 and 16 weeks, compared to EM0 and negative control. The effective infection control by EM-NFs was further confirmed by hard tissue section analysis. The Bone implant contact (BIC) and bone area fraction Occupancy (BAFO) within 200 µm of the surface of the pins were used to evaluate the osseointegration and new bone formation around the implants. At 16 weeks, the bone implant contact (BIC) of EM 100 (35.08%) was higher than that of negative control (3.43%) and EM0 (0%). The bone area fraction occupancy within 200 µm (BAFO) of EM100 (0.63 mm2) was higher than that of negative control (0.390 mm2) and EM0 (0.0 mm. 2. ). The BAFO of EM100 was also higher than that of EM1000 (0.3mm. 2. ). There was much less osteolysis observed with EM100 and EM1000 NF coatings at 16 weeks, as compared to EM0 positive control, p=0.08 and p=0.1, respectively. Osseointegration and periprosthetic bone formation was enhanced by EM-NFs, especially EM100. Data from this pilot study is promising for improving implant surface fabrication strategies

Abstract. Objectives. There is debate regarding the optimal surgical technique for fixing femoral diaphyseal fractures in children aged 4 to 12 years. The aim of this study was to conduct a systematic review and meta-analysis to compare the complication rate following flexible intramedullary nailing (FIN), plate fixation and external fixation (EF) for traumatic femoral diaphyseal fractures in children aged 4 to 12. Methods. We searched MEDLINE, EMBASE and CENTRAL databases for interventional and observational studies. Two independent reviewers screened, assessed quality and extracted data from the identified studies. The primary outcome was the risk of any complication. Results. Nine randomised controlled trials (RCTs) and 19 observational studies fulfilled the eligibility criteria. Within the RCTs, five analysed FIN (n=161), two analysed plates (n=51) and five analysed EF (n=168). Within the observational studies, 13 analysed FIN (n=610), seven analysed plates (n=214) and six analysed EF (n=153). The overall risk of complications was lower following plate fixation when compared to FIN (RR 0.45, 95% CI 0.28 to 0.73, p=0.001) in the observational studies. The overall risk of complications was higher following EF when compared to FIN in both RCTs (RR 1.94, 95% CI 1.25 to 3.01, p=0.003) and observational studies (RR 1.97, 95% CI 1.50 to 2.58, p<0.001). The overall risk of complications was higher following EF when compared to plate fixation in both RCTs (RR 7.42, 95% CI 1.84 to 29.98, p=0.005) and observational studies (RR 4.39, 95% CI 2.64 to 7.30, p<0.001). Conclusions. This study reports a significantly decreased relative risk of complications when femoral diaphyseal fractures in children aged 4 to 12 are managed with plates. The overall quality of evidence is low, highlighting the need for a prospective multicentre randomised trial at low risk of bias due to randomisation and outcome measurement to identify if any fixation technique is superior

In recent years, there has been increasing interest in the use of simultaneous hip arthroplasty compared to staged procedures in patients with bilateral pathology. The aim of this study was to compare simultaneous and staged hip arthroplasty in patients with bilateral pathology by assessing the transfusion rate, postoperative hemoglobin drop, length of stay (LOS), in-hospital complications, 30-days readmissions, leg length difference and early functional outcome. We conducted a retrospective cohort study that included all patients who were undergoing primary total hip arthroplasty (THA) by a single surgeon in a high-volume arthroplasty center between 2015 and 2020 as simultaneous or staged procedures. Staged bilateral arthroplasties were performed within 12 months and were stratified by the time between procedures. Data was acquired through the electronic files at the Orthopädische Chirurgie München (OCM). For functional outcome we compared the ability of the patients to walk independently on the ward and the ability to walk a set of stairs alone which was recorded daily by the attending physiotherapist. In total n=290 patients were assessed for eligibility and included in this study. One hundred and thirty eight patients were allocated to the staged arthroplasty group. The second staged procedure was performed within 12 months of the first procedure. One hundred and fifty two patients were allocated to the simultaneous arthroplasty group. No statistical difference was found between the two groups regarding demographic data. Primary outcome measurements: There was no significant difference in transfusion rate or complication rate (p=0.1147). In both groups the transfusion rate was actually 0%. Secondarily, no statistically significant difference was found between the postoperative hemoglobin drop (p=0.1147) and the functional outcome (p=0.7249), nor the length of stay (LOS) (p=: 0.6415), as well as the 30 days readmission rate between both groups. No difference was found in leg length in the simultaneous group. The OR time in the simultaneous group ranged from 62min to 111min with an average of 77min. No surgery exceeded a 120min window. We observed no significant differences in transfusion rate, in hospital complications, as well as readmission rate between both groups. The early functional outcome showed no significant difference in mobility. Simultaneous hip arthroplasty is as safe as a staged procedure, with no higher risk for the patient, in a specialized high volume center with a specialized surgeon and an adequate team. Level of evidence: Level IV

Introduction and Objective. The most common paediatric orthopaedic injury requiring hospital admission is a femoral fracture. There is debate regarding the optimal surgical technique for fixing femoral diaphyseal fractures in children aged 4 to 12 years. The National Institute for Health and Care Excellence (NICE) and the American Academy of Orthopaedic Surgeons (AAOS) have issued relevant guidelines, however, there is limited evidence to support these. The aim of this study was to conduct a systematic review and meta-analysis to compare the complication rate following flexible intramedullary nailing (FIN), plate fixation and external fixation (EF) for traumatic femoral diaphyseal fractures in children aged 4 to 12. Materials and Methods. We searched MEDLINE, EMBASE and CENTRAL databases for interventional and observational studies. Two independent reviewers screened, assessed quality and extracted data from the identified studies. The primary outcome was the risk of any complication. Secondary outcomes assessed the risk of pre-specified individual complications. Results. Nine randomised controlled trials (RCTs) and 19 observational studies (six prospective and 13 retrospective) fulfilled the eligibility criteria. Within the RCTs, five analysed FIN (n=161), two analysed plates (n=51) and five analysed EF (n=168). Within the observational studies, 13 analysed FIN (n=610), seven analysed plates (n=214) and six analysed EF (n=153). The overall risk of complications was lower following plate fixation when compared to FIN fixation (RR 0.45, 95% CI 0.28 to 0.73, p=0.001) in the observational studies. The overall risk of complications was higher following EF when compared to FIN fixation in both RCTs (RR 1.94, 95% CI 1.25 to 3.01, p=0.003) and observational studies (RR 1.97, 95% CI 1.50 to 2.58, p<0.001). The overall risk of complications was higher following EF when compared to plate fixation in both RCTs (RR 7.42, 95% CI 1.84 to 29.98, p=0.005) and observational studies (RR 4.39, 95% CI 2.64 to 7.30, p<0.001). Conclusions. Although NICE and the AAOS recommend FIN for femoral diaphyseal fractures in children aged 4 to 12, this study reports a significantly decreased relative risk of complications when these injuries are managed with plates. Our findings provide valuable information to healthcare professionals who are involved in discussing the risk and benefits of different management options with patients and their families. The overall quality of evidence is low, highlighting the need for a rigorous prospective multicentre randomised trial at low risk of bias due to randomisation and outcome measurement to identify if any fixation technique is superior

This review compares the outcomes and complication rates of three surgical strategies used for the management of symptomatic os acromiale. The purpose of this study was to help guide best practice recommendations. A systematic review of nine prospective studies, seven retrospective studies, and three case studies published across ten countries between 1993 and 2018 was performed. Adult patients (i.e., ≥ 18 years of age) with a symptomatic os acromiale that failed nonoperative management were included in this review. Surgical techniques utilized within the included studies include excision, acromioplasty, and open reduction and internal fixation (ORIF). The primary outcomes of interest included patient satisfaction and return to activity. Range of motion and several standardized outcome measurement tools were also included in the final analysis. Patient satisfaction was highest in the excision and ORIF groups, with 92% and 82% of patients reporting good to excellent postoperative results, respectively, compared to 63% in the acromioplasty group. All three patient groups experienced improved postoperative objective scores (i.e., patient-reported outcome scores and active range of motion). The excision group experienced a complication rate of 1%, while the acromioplasty group experienced a complication rate of 11% and the ORIF group a rate of 67%. This study reports on the largest sample of patients who have undergone surgical treatment for a symptomatic os acromiale. We have demonstrated that excision of the os with repair of the deltoid resulted in the best clinical outcomes with the least complications. In healthy adult patients with a large os fragment and a normal rotator cuff, surgical fixation may provide increased preservation of deltoid function while offering good patient satisfaction. Such patients should be aware that they are at increased risk of requiring a second procedure due to symptomatic hardware following ORIF

In light of recent regulatory initiatives, medical devices now require additional clinical evidence to prove their safety and efficacy. At the same time, patients' own assessment of their devices' function and performance has gained in importance. The collection of these data allows for a more comprehensive picture of clinical outcomes and complications following total knee arthroplasty (TKA). These trends have led researchers to search for new methods of acquiring, interpreting and disseminating patient-reported outcome measurements (PROMs). The current study assesses the feasibility of a digital platform for collecting PROMs that was recently adapted for TKA patients. It sought to determine patient engagement, survey completion rates, and satisfaction with this platform. Eighty-two patients (mean age, 63.7 years, 59% females) scheduled for TKA were enrolled from one US and six UK sites between January 12, 2018 and April 30, 2018. Patients were supplied with a mobile application (app) that collects a variety of PROMs, including four domains based on the Patient-Reported Outcome Information System (PROMIS™): physical function, depression, pain interference and pain behavior. The platform electronically administers questionnaires using computer-adaptive tests (CATs), which reduce the burden on patients by tailoring follow-up questions to account for their previous answers. Satisfaction with the app was assessed in subset of patients who evaluated its ease-of-use (n=45), likelihood that they would recommend it to family/friends (n=35), and whether they successfully used the information it provided during their recovery (n=31). These scores were taken on a 1 to 10 (worst to best) scale. Patients demonstrated regular engagement with the platform, with 73% using the app at least once a week. Weekly engagement remained high throughout the seven-week post-operative period (Figure 1). There was a 69% completion rate of all PROMIS™ CAT surveys during the study. The four PROMIS™ CAT domains had similar survey completion rates (Figure 2). The subset of patients queried regarding their satisfaction with the app gave it favorable mean scores for ease-of-use (8.8), likelihood to recommend to a family member or friend (8.1), and their success at using its information to improve their recovery (7.4). Initial results support this digital platform's potential for successfully and efficiently collecting large volumes of PROMs. Patients reported high levels of engagement and satisfaction. For any figures or tables, please contact authors directly

Introduction. Total Knee Arthroplasty (TKA) has been demonstrated to drastically improve a patient's quality of life. The outcomes following TKA are often reported by subjective patient reported outcome measurements (PROMs). However, there are few objective outcome measures following TKA, limiting the amount of information physicians can use to effectively guide a patient's recovery, especially in the first 3 weeks. Newly developed knee sensors have been able to ameliorate this problem by providing the physician with previously unobtainable objective data. Our study aims to evaluate the use of a wearable knee sensor device to measure functional outcomes (range of motion and steps) in real time. Methods. 29 patients who underwent primary, unilateral TKA were recruited for this IRB approved study. Patients were instructed how to use the device and associated mobile phone application preoperatively (Figure 1) and provided knee sensors to wear postoperatively (Figure 2). Patients wore the device for 3 weeks postoperatively to allow for data collection. The device recorded range of motion, number of steps, and percentage of physical therapy exercises completed. Patients were grouped by gender, age (<69 or >=70 years old), and BMI (<30 and >=30 kg/m2) for analysis of functional outcome measurements (maximum flexion, minimum extension, and number of steps). Unpaired two-sample t-tests were used to analyze differences between the groups. Results. Patients were able to tolerate wearing the device without complication and the device collected functional outcome data appropriately as designed. After brief instruction, both patients and physicians were able to monitor patient data via the mobile phone application in real time. The mean maximum flexion and minimum extension did not significantly change from postoperative week 1 to postoperative week 2 and week 3. However, the mean number of steps taken increased from 4,923 steps in postoperative week 1 to 8,163 steps week 2 (p=0.01) and 11,615 steps week 3 (p<0.001) postoperatively. There were no statistically significant differences in maximum flexion, minimum extension, and number of steps between the different gender, age, and BMI groups. Discussion and Conclusion. The knee sensor device used in our study proved to be useful in providing objective functional outcomes following TKA. The device was well tolerated by patients and the mobile phone applications were easy to use for the physicians and the patients. Real time tracking of patients' own range of motion, number of steps, and percentage of exercises completed may motivate them to further their own recovery process. There were wide ranges in the number of steps taken during each postoperative time interval. These results may help identify individuals who are recovering at a faster rate or those who may need more focused physical therapy. Subsequent larger studies can utilize the device to elucidate previously unknown recovery trends among different groups of patients following TKA. In the future, the device's ability to collect real time functional outcome data will allow physicians and other healthcare providers to create individualized physical therapy plans, thereby optimizing the patient's recovery process. For figures, tables, or references, please contact authors directly

Introduction. Direct anterior approach (DAA) total hip arthroplasty (THA) has been reported to improve early outcomes as compared to posterior approach THA up to 6 weeks post-operatively. However, very few detailed results have been reported within the first 6 weeks. In this study we investigate the effect of surgical approach on THA outcome via weekly assessment. Methods. Patients undergoing THA for primary osteoarthritis were prospectively enrolled. Data was collected pre-operatively and post-operatively at weekly intervals for 6 weeks. Outcome scores and additional functional measures were compared using unpaired t-test, effect size, and Pearson correlation coefficients. Results. 111 patients (55 DAA and 56 posterior approach) were enrolled. There was no significant difference (p>0.05) in pre-surgical Patient Reported Outcome Measurement Information System (PROMIS) Pain interference and Physical Function scores, VAS Pain, and Modified Harris Hip Scores (mHHS). Post-operatively, the DAA group had decreased length of stay [1.4 vs 2.2 days, p=0.0002] and increased distance walked on postoperative day 1 and 2 [95 vs 52 ft, p=0.011 and 251 vs. 163 ft, p=0.0004, respectively]. The DAA group had lower VAS pain scores [p<0.05] and required less day 1 and total narcotics [59 vs 80 morphine equivalents, p=0.029 and 138 vs 190, p=0.01, respectively]. The DAA cohort had improved PROMIS Physical Function scores and mHHS up to 5 weeks post- operatively. Anterior approach patients discontinued their assistive device 8 days earlier [p=0.01], left home 3 days earlier [p=0.001], and drove a car 5 days earlier [p=0.016] compared to posterior patients. Conclusion. Patients undergoing DAA THA had significantly shorter length of stay, improved mobilization, decreased narcotic requirements and improved inpatient VAS pain scores compared to mini-posterior THA. Furthermore, DAA patients discontinued their assistive device, left their home, and drove a car sooner than posterior approach patients. The significant improvement in physical function seen with DAA THA persisted up to 5 weeks post-operatively

Introduction. Lack of standardization of outcome measurement has hampered an evidence-based approach to clinical practice and research. We report on the progress on establishing a minimal set of core domains for outcome measurement in distal radius fracture. Materials and methods. Participants included an expert panel of orthopaedic surgeons, outcome researchers, patients, physiotherapists, industry representatives involved in distal radius research and partners in regulatory affairs. Decisions were made by review of evidence and theory and establishing group consensus. Results. There was consensus that clinical research studies should include a proof of concept outcome that would directly assess the presumed direct benefit of the intervention. We identified a need for additional outcome measures for research including measures that provide more detail on pain and function; or that address supplemental concepts important to that study. Measures of fracture healing/alignment, grip strength, joint motion were recognized as commonly utilized secondary outcomes. Discussion and Conclusion. Our approach provides preliminary steps in establishing core domains that have content relevant to patient goals (i.e. pain and function) and the providers’ treatment goals (i.e. strength, range of motion, function). The panel recommendations provide flexibility in establishing customized data collection for specific indications; but offer some core consistency

Introduction. Several surgical approaches are available for elective total hip arthroplasty (THA) for osteoarthritis. While posterior surgical approaches are the most common, interest in a direct anterior (Hueter) approach is increasing because of alleged advantages in convalescence. However, no studies have examined differences in patient-reported global and condition-specific measures of health across multiple institutions. The ongoing Pulmonary Embolism Prevention after Hip and Knee Replacement (PEPPER) study is a PCORI-funded multicenter pragmatic clinical trial randomizing patients to three different antithrombotic regimens. We analyzed operative data from PEPPER to compare pre-post changes in validated patient-reported outcome measures after THA based on surgical approach. Methods. Participants (age 21 or older) were recruited from 27 academic medical centers for the PEPPER trial. Eligibility screening, baseline measures, and operative detail were entered into a central database with standardized blinded post-operative data collection protocol. We included participants undergoing elective primary total hip arthroplasty, excluding those undergoing revision, resurfacing, bilateral procedures, on chronic preoperative anticoagulation, with a recent history of gastrointestinal, cerebral, or other hemorrhage, defective hemostasis, or uncontrolled hypertension. Participating centers reported the operative approach as “Posterior”, “Transgluteal”, or “Anterior”. The brief version of the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS Jr.) and the Patient Reported Outcome Measurement Information System Global Survey (PROMIS10) were ascertained pre-operatively, and at 1, 3 and 6 months post-operatively. Mixed-effects linear regression was used to compare difference in patient-reported outcomes over time based on surgical approach, adjusting for baseline measures of health outcome, patient age, sex, race, ethnicity, BMI, comorbidity, education, work status, alcohol use, and smoking status. Results. As of 5/15/2018, a total of 1,238 patients had undergone primary THA as part of the PEPPER trial and were being monitored postoperatively, including 51.6% involving posterior, 18.1% transgluteal, and 30.3% anterior surgical approaches. Mean preoperative HOOS Jr. scores for posterior approach (47.6; 95%CI 46.4 – 48.7) were similar to transgluteal (47.4, 95%CI 45.4 – 49.5, p=0.654) and anterior (48.9, 95%CI 47.4 – 50.4, p=0.461) approaches. At 6-month follow-up, adjusted mean HOOS Jr. Scores significantly improved for all groups, but were not statistically different between groups. The adjusted mean HOOS Jr. score at 6 months was 85.6 for those undergoing a posterior (95%CI 83.7 – 87.5), 83.6 for transgluteal (95%CI 79.0 – 88.2, p=.474) and 85.0 for anterior approaches (95%CI 82.6 – 87.5, p=0.255). Baseline PROMIS-10 Physical Function scores were similar between posterior (40.1; 95%CI 40.2 – 41.3), transgluteal (40.6, 95%CI 39.6 – 41.6, p=0.716), and anterior approaches (41.5, 95%CI 40.8 – 42.3, p=0.390), with similar postoperative improvement through 6 months (posterior=52.1, 95%CI 51.2 – 53.0; transgluteal=52.4, 95%CI 50.2 – 54.5, p=0.734; anterior=52.8, 95%CI 51.6 – 53.9, p=0.414). These findings were robust utilizing a variety of methods to account for missing responses. Conclusion. We found similar short-term improvements in patient-reported global measures of health between posterior, transgluteal, and anterior surgical approaches for elective THA, and a trend suggesting inferior early patient-reported measures of function with a trans-gluteal surgical approach

Objective. The optimal dosage and timing of tranexamic acid in total hip arthroplasty (THA) still is undetermined. Previous studies showed the hyper-fibrinolysis would last for 18 hours after surgery. The study aimed to examine the efficacy and safety of multiple bolus of intravenous TXA on hidden blood loss and inflammation response following primary THA. Methods. 150 patients were randomly divided into three groups to receive single bolus of 20 mg/kg IV-TXA before skin incision (Group A), or another bolus of 1 g IV-TXA 3 hours later (Group B), or another two boluses of 1g IV-TXA 3 hours and 6 hours later (Group C). All patients received a standard perioperative enhanced recovery protocol. The primary outcomes was hidden blood loss. Other outcome measurements such as hemoglobin level, total blood loss, transfusion rate, inflammation markers (CRP, IL-6), VAS pain score, length of hospital stay (LOH) and venous thromboembolism (VTE) were also compared. Results. The hidden blood loss in group C was 402.13 ± 225.97 ml, which was less than that in group A (679.28±277.16 ml, p< 0.001) and group B (560.62±295.22 ml, p= 0.010). However, such difference was not detected between group A and B (p= 0.072). The mean value of total blood loss in group A, B and C were 1090.78±251.41, 979.42±247.89, 768.71±180.19 ml, respectively, with a significant intergroup difference (p <0.001). The Hb drop on postoperative day (POD) 3 in group A, B and C was 30.82±6.31, 27.16±6.83, 21.98±3.72 g/L, and the difference between groups was significant (p <0.001). Only one patients received red blood cell transfusion. The mean level of CRP in group C was lower than that in group A and B on POD 2 (p= 0.000, p= 0.034), POD 3 (p= 0.000, p= 0.014). The serum level of IL-6 in group C was lower than group A on POD 1, POD 2 and POD 3 (p=0.017, p=0.023, p= 0.005; respectively). The patients in group C had slightly less postoperative pain. The LOH in group C was shorter than those in group A (p= 0.023). No episodes of VTE or other adverse events occurred in any patient. Conclusion. Multiple boluses of IV-TXA can effectively reduce hidden blood loss following primary THA. What is the most important is that, by adding another boluses of IV-TXA, patients can gain a smaller decline of Hb, less postoperative inflammation response, less pain and shorter length of hospital stay

Introduction: Many knee outcomes measures have recently been developed and validated. However, most of these are lengthy and too cumbersome to use in a busy sports medicine practice. The purpose of this study was to develop a one-page outcomes form that documents function, activity and patient satisfaction for collection of knee outcomes data in a format that can be analyzed easily so that a surgeon may better assess the outcomes of the therapeutic regimens used. Methods: Validated knee questionnaires were evaluated for their length and ease of scoring. Scores were evaluated for test-retest reliability, floor and ceiling effects, criterion validity, construct validity, and responsiveness to change. In addition, the psychometric properties of a single-item patient satisfaction instrument with outcomes score were studied. Results: The Lysholm score and Tegner activity scale are short in length and provide a validated outcomes measurement tool for several sports medicine procedures. In addition to being validated for ACL, meniscus, and chondral defects, we tested their psychometric properties in patients seeking treatment for osteoarthritis of the knee. The Tegner scale and overall Lysholm score showed acceptable test-retest (ICC = 0.87 and 0.79, respectively) reliability, floor and ceiling effects, criterion validity, construct validity, and responsiveness to change. The standard error of the Lysholm was 6.7 and the minimum detectable change at 95% confidence level (MDC95) was 16. For the Tegner score, the standard error was 0.60 and the MDC95 was 1.2. For the one-item patient satisfaction scale, there was an acceptable floor (4.3%) but a high ceiling (39.4%) effect. There was acceptable criterion validity with significant (p< 0.05) correlations between the satisfaction with surgical outcomes and the validated Group Health of America Consumer Satisfaction Survey. There was acceptable construct validity with all hypotheses demonstrating significance (p< 0.05). Acceptable responsiveness to change was found. Conclusions: The Lysholm score, the Tegner activity scale, and a one-item patient satisfaction with outcomes scale provide a valid one-page knee outcomes measurement form. This simple form allows the collection of knee outcomes data in a busy sports medicine practice to help surgeons better assess the clinical outcomes in their patients