Effect of Osteochondroplasty on Time to Reoperation After Arthroscopic Management of Femoroacetabular Impingement: Analysis of a Randomized Controlled Trial.

Background: A subset of patients with femoroacetabular impingement (FAI) fail arthroscopic management. It is not clear which patients will fail surgical management; however, several surgical and patient factors, such as type of procedure and age, are thought to be important predictors. Purpose: This time-to-event analysis with a 27-month follow-up analysis compared the effect of (1) arthroscopic osteochondroplasty with or without labral repair versus (2) arthroscopic lavage with or without labral repair on the time to reoperation in adults aged 18 to 50 years with FAI. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Eligible participants had been randomized in a previous study trial to a treatment of arthroscopic osteochondroplasty or arthroscopic lavage with or without labral repair. Using the comprehensive data set from the Multinational Femoroacetabular Impingement Randomized controlled Trial, all reoperations until 27 months after surgery were identified. The analysis was conducted using a Cox proportional hazards model, with percentage of patients with a reoperation evaluated in a time-to-event analysis as the outcome. The independent variable was the procedure, with age and impingement subtype explored as potential covariates. The effects from the Cox model were expressed as the hazard ratio (HR). All tests were 2-sided, with an alpha level of .05. Results: A total of 108 patients in the osteochondroplasty group and 106 patients in the lavage group were included. The mean age of the patients included in the study was 36 ± 8.5 years. Overall, 27 incident reoperations were identified within the 27-month follow-up, with an incidence rate of 6 per 100 person-years. Within the osteochondroplasty group, 8 incident reoperations were identified (incidence rate, 3.4 per 100 person-years), while within the lavage group, 19 incident reoperations were identified (incidence rate, 8.7 per 100 person-years). The hazard of reoperation for patients undergoing osteochondroplasty was 40% of that of patients undergoing lavage (HR, 0.40 [95% CI, 0.17-0.91] P = .029). Conclusion: This study demonstrated that for adults between the ages of 18 and 50 years with FAI, arthroscopic osteochondroplasty was associated with a 2.5-fold decrease in the hazard of reoperation at any point in time compared with arthroscopic lavage. Registration: NCT01623843 (ClinicalTrials.gov identifier).

"Is it us or is it me?": Family experiences of connectedness following a reflecting team intervention.

The present study examined family-wide versus individual perceptions of, and changes in, family connectedness in response to a one-time reflecting team (RT) intervention. Seventy-six families (N = 208 individuals), recruited during family therapy, completed family connectedness measures before and after the RT intervention. A subset of adults (n = 26) completed 1-week follow-up measures. Three-level (family, individual, time) multilevel models were used to partition sources of variance in connectedness while permitting different fixed and random effects for adults and minors. Results indicate that family connectedness is a characteristic of whole-families (34% of the variance), individuals (43%), and change over time (23%), including measurement error. Additionally, participants reported higher family connectedness after the RT. This study demonstrates the importance of considering family connectedness as a multilevel relationship construct that potentially changes in response to RT.

Osteochondroplasty and Labral Repair for the Treatment of Young Adults With Femoroacetabular Impingement: A Randomized Controlled Trial.

BACKGROUND: Femoroacetabular impingement (FAI) is a condition known to cause hip pain in young adults. PURPOSE: To evaluate the efficacy of the surgical correction of FAI via arthroscopic osteochondroplasty with or without labral repair compared with arthroscopic lavage of the hip joint with or without labral repair. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 220 male and female participants aged 18 to 50 years with nonarthritic FAI suitable for surgical treatment were recruited for the trial at 10 clinical centers in Canada, Finland, and Denmark between October 2012 and November 2017, of whom 214 were included in the final analysis. In the osteochondroplasty group, cam- and/or pincer-type lesions were resected using fluoroscopic guidance. In the lavage group, the joint was washed out with 3 L of normal saline. Surgeons were instructed to repair the labrum in both groups if it was mechanically unstable once probed, showing visible displacement or chondrolabral separation. The primary outcome was patient-reported pain (using the 100-point visual analog scale [VAS]) at 12 months. Secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool), physical and mental health (12-Item Short Form Health Survey), and health utility (EuroQol-5 Dimensions) at 12 months as well as any reoperations and other hip-related adverse events at 24 months. RESULTS: At 12 months, there was no difference in pain (VAS) between the groups (mean difference [MD], 0.11 [95% CI, -7.22 to 7.45]; P = .98). Also, 88.3% (189/214) of participants had a labral tear, of which 60.3% were repaired. For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, -5.03 [95% CI, -10.40 to -0.03]; P = .049). By 24 months, there were significantly fewer reoperations reported in the osteochondroplasty group (8/105) than the lavage group (19/104) (odds ratio, 0.37 [95% CI, 0.15-0.89]; P = .026). The primary reasons for a reoperation included hip pain (15/27; 55.6%) and a reinjury of the labrum (11/27; 40.7%). CONCLUSION: Both the osteochondroplasty and the lavage groups with or without labral repair for FAI had significantly improved pain or function significantly at 1 year. By 2 years, the reoperation rate was significantly lower in the osteochondroplasty group. REGISTRATION: NCT01623843 (ClinicalTrials.gov identifier).

Tezepelumab, an anti-thymic stromal lymphopoietin monoclonal antibody, in the treatment of moderate to severe atopic dermatitis: A randomized phase 2a clinical trial.

BACKGROUND: Tezepelumab (AMG 157/MEDI9929), a first-in-class monoclonal antibody, targets thymic stromal lymphopoietin, a cytokine that is implicated in the pathogenesis of atopic dermatitis (AD). OBJECTIVE: We sought to evaluate the efficacy and safety of tezepelumab in adults with moderate to severe AD. METHODS: In this phase 2a study (NCT02525094), 113 patients were randomized 1:1 to subcutaneous tezepelumab 280 mg or placebo every 2 weeks, plus class 3 topical corticosteroids (TCS). The primary endpoint was the week 12 response rate for a ≥50% reduction in the Eczema Area and Severity Index (EASI50). Secondary endpoints including EASI75, Investigator's Global Assessment, SCORAD 50, SCORAD 75, pruritus numeric rating and 5-D itch scales, and exploratory endpoints (including EASI90) were assessed at weeks 12, and 16 (post hoc). RESULTS: A numerically greater percentage of tezepelumab plus TCS-treated patients achieved EASI50 (64.7%) versus placebo plus TCS (48.2%; P = .091). Numerical improvements over placebo were demonstrated for week 12 secondary and exploratory endpoints, with further improvements at week 16. Treatment-emergent adverse events were similar between treatment groups. LIMITATIONS: Greater than expected response rates in placebo-treated patients were possibly attributable to TCS. CONCLUSION: Although not statistically significant, numerical improvements over placebo for all week 12 endpoints were demonstrated, with greater week 16 responses.

First year nursing students use of social media within education: Results of a survey.

INTRODUCTION: Social media rapidly disseminates information but is a controversial learning platform in nurse education. This study aimed to explore how students viewed the use of Twitter, and other social media, in their first year of a nursing degree. AIM: The aim of this study was to evaluate first year student nurses' use of social media, before and after commencing a pre-registration programme, where Twitter was used in a module. METHODOLOGY: A cross-sectional approach using a descriptive survey was completed. METHODS: An online survey, that included Likert scale and open questions, was open for one month in 2016. SAMPLE: All students on Nursing Undergraduate Degrees, in Adult, Child and Mental Health, who were in the first year of their programme were eligible to participate. 121 students took part with a response rate of 32%. RESULTS: Most students were positive about using social media as they found it an engaging way to promote discussion and share information. Students use of Twitter changed in the first year with 19.8% using it once or more per week on commencement of the programme which increased to 45.5%; other social media platforms remained static. Most students (57.8%) understood the purpose of using Twitter although 14% reported that it was not used within their module; thus, not all students gained experience of using the social media. 81% of students said that using Twitter had been beneficial to increase awareness of nursing issues within their course. However, there were areas that students found difficult such as time, and not knowing what to say. CONCLUSION: The study suggests that teaching about social media, and incorporating it into learning activities, may be beneficial for students. However, more research into the subject using an experimental design to assess changes over time would be useful.

Pharmacokinetics, Pharmacodynamics, and Safety of MEDI4212, an Anti-IgE Monoclonal Antibody, in Subjects with Atopy: A Phase I Study.

INTRODUCTION: The anti-IgE therapy omalizumab is currently licensed for the treatment of moderate to severe allergic asthma and chronic idiopathic urticaria. Owing to limitations in the use of omalizumab, a need exists for optimized anti-IgE therapies to broaden clinical indications and patient populations, and to improve dosing schedules. The objective of this phase I, randomized, placebo/omalizumab-controlled, first-in-human, dose-escalation study was to evaluate the pharmacokinetics, pharmacodynamics, and safety of the high-affinity, anti-IgE therapy MEDI4212 in non-Japanese and Japanese subjects with atopy and/or diagnostic IgE ≥ 30 IU/mL. METHODS: Subjects with atopy and/or baseline IgE ≥ 30 IU/mL were randomized to a single dose of subcutaneous (5, 15, 60, 150, or 300 mg) or intravenous (300 mg) MEDI4212, subcutaneous omalizumab, or placebo. Following administration, pharmacokinetic, pharmacodynamic [IgE (free and total), and cellular FcεRI expression], and safety assessments were made. RESULTS: MEDI4212 rapidly suppressed free serum IgE to a greater extent than omalizumab; however, recovery of free IgE to baseline in MEDI4212-dosed subjects was rapid when compared with the slow and gradual recovery seen in omalizumab-dosed individuals. The loss of IgE suppression corresponded with a rapid decrease of serum MEDI4212. FcεRI expression on dendritic cells and basophils was reduced following MEDI4212 dosing. MEDI4212 was well tolerated by subjects; adverse events were generally of low severity and no subjects discontinued due to adverse events. CONCLUSIONS: The increased potency of MEDI4212 may be of clinical interest for individuals with high-diagnostic IgE levels where more extensive IgE suppression is required for clinical response. However, the modest duration of free IgE suppression below the target concentration noted with MEDI4212 in this study suggests limited potential for dosing schedule advantages over omalizumab. FUNDING: MedImmune. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01544348.

Cartilage Restoration of the Knee: A Systematic Review and Meta-analysis of Level 1 Studies.

BACKGROUND: Focal cartilage defects of the knee are a substantial cause of pain and disability in active patients. There has been an emergence of randomized controlled trials evaluating surgical techniques to manage such injuries, including marrow stimulation (MS), autologous chondrocyte implantation (ACI), and osteochondral autograft transfer (OAT). PURPOSE: A meta-analysis was conducted to determine if any single technique provides superior clinical results at intermediate follow-up. STUDY DESIGN: Systematic review and meta-analysis of randomized controlled trials. METHODS: The MEDLINE, EMBASE, and Cochrane Library databases were systematically searched and supplemented with manual searches of PubMed and reference lists. Eligible studies consisted exclusively of randomized controlled trials comparing MS, ACI, or OAT techniques in patients with focal cartilage defects of the knee. The primary outcome of interest was function (Lysholm score, International Knee Documentation Committee score, Knee Osteoarthritis Outcome Score) and pain at 24 months postoperatively. A meta-analysis using standardized mean differences was performed to provide a pooled estimate of effect comparing treatments. RESULTS: A total of 12 eligible randomized trials with a cumulative sample size of 765 patients (62% males) and a mean (±SD) lesion size of 3.9 ± 1.3 cm(2) were included in this review. There were 5 trials comparing ACI with MS, 3 comparing ACI with OAT, and 3 evaluating different generations of ACI. In a pooled analysis comparing ACI with MS, there was no difference in outcomes at 24-month follow-up for function (standardized mean difference, 0.47 [95% CI, -0.19 to 1.13]; P = .16) or pain (standardized mean difference, -0.13 [95% CI, -0.39 to 0.13]; P = .33). The comparisons of ACI to OAT or between different generations of ACI were not amenable to pooled analysis. Overall, 5 of the 6 trials concluded that there was no significant difference in functional outcomes between ACI and OAT or between generations of ACI. CONCLUSION: There is no significant difference between MS, ACI, and OAT in improving function and pain at intermediate-term follow-up. Further randomized trials with long-term outcomes are warranted.

Pre-operative intra-articular hip injection as a predictor of short-term outcome following arthroscopic management of femoroacetabular impingement.

PURPOSE: Diagnostic hip injections are often used to confirm intra-articular pathology prior to arthroscopic treatment for femoroacetabular impingement (FAI). However, little is known whether the type of response correlates with the post-operative functional outcomes. The purpose of this study is to document the ability of a diagnostic hip injection to predict short-term functional outcomes following arthroscopic surgical management. METHODS: A prospective cohort of 52 patients diagnosed with FAI who had an intra-articular hip injection prior to arthroscopic surgery was evaluated. A pain diary was used during the 2 weeks after hip injection to document response. In addition, the modified Harris Hip Score (mHHS) was administered preoperatively and 6 months post-operatively to assess functional outcomes. The relationship between response to an intra-articular hip injection and mHHS scores 6 months after FAI surgery was evaluated. RESULTS: Overall, 42 of 52 (81 %) patients diagnosed with FAI achieved pain relief from the hip injection. Outcomes according to mHHS scores improved significantly at the 6-month follow-up visit (19 points, 95 % CI 15-24, p = 0.001). The therapeutic utility of the hip injection suggested that lack of pain relief predicted a lack of functional improvement following arthroscopic surgery. CONCLUSION: In this study, the data suggests that a positive response from an intra-articular hip injection is not a strong predictor of short-term functional outcomes following arthroscopic management of FAI. However, a negative response from an intra-articular hip injection may predict a higher likelihood of having a negative result from surgery.

Consistency of reported outcomes after arthroscopic management of femoroacetabular impingement.

PURPOSE: The purpose of this systematic review is to evaluate the consistency of the reporting of clinical and radiographic outcomes after arthroscopic management of femoroacetabular impingement (FAI). METHODS: Two databases (Medline and EMBASE) were screened for clinical studies involving the arthroscopic management of FAI. A full-text review of eligible studies was conducted, and the references were searched. Inclusion and exclusion criteria were applied to the searched studies, and a quality assessment was completed for included studies. RESULTS: We identified 29 eligible studies involving 2,816 patients. There was a lack of consensus with regard to reported outcomes (clinical and radiographic) after arthroscopic treatment of FAI. Clinical outcomes reported include the Harris Hip Score (45%) and the Non-Arthritic Hip Scale (28%), range of motion (34%), pain scores (24%), and patient satisfaction (28%). The most commonly reported radiographic outcomes included the alpha angle (38%), head-neck offset (14%), and degenerative changes (21%). CONCLUSIONS: There is significant variation in reported clinical and radiographic outcomes after arthroscopic treatment of FAI. This study highlights the need for consistent outcome reporting after arthroscopic FAI surgery. LEVEL OF EVIDENCE: Level IV, systematic review of Level II, III, and IV studies.

Surgical indications for treatment for femoroacetabular impingement with surgical hip dislocation.

PURPOSE: There is a lack of detailed information about the indications of surgical treatment for femoroacetabular impingement (FAI), particularly using open surgical dislocation. The purpose of this review was to systematically review the reported indications for surgical dislocation of the hip for FAI. METHODS: Two databases (MEDLINE and EMBASE) were screened for clinical studies involving the treatment for FAI with surgical hip dislocation. We conducted a full-text review and the references for each included paper were hand-searched for other eligible studies. Papers published until September 2011 were included in this review. Two individuals reviewed all identified studies independently, and any disagreement was resolved through consensus. RESULTS: Fifteen studies met the eligibility criteria, which included a total of 822 patients. We identified a lack of consensus for clinical and radiographic indications for surgical hip dislocation to treat FAI. The most common clinical indications reported were clinical symptoms such as hip pain in 10 papers (67 %), a positive impingement sign in 9 papers (60 %), painful/reduced range of motion in 9 papers (60 %), activity-related groin pain in 4 papers (27 %), and non-responsive to non-operative treatment in 4 papers (27 %). The most commonly reported radiographic indicators for surgical hip dislocation were a variety of impingement findings from radiographs in all 15 included papers (100 %), a combination of radiographs and MRA in 5 papers (33 %) or radiographs and MRI in 3 papers (20 %). CONCLUSIONS: These results showed that that there was an inconsistency between the clinical and radiographic indications for surgical hip dislocation as a treatment for femoroacetabular impingement. This review suggests that there is a need for the development of standardized clinical and radiological criteria that serve as guidelines for surgical treatment for FAI. LEVEL OF EVIDENCE: Systematic review, Level IV.