Comparison between dedicated MRI and symphyseal fluoroscopic guided contrast agent injection in the diagnosis of cleft sign in athletic groin pain and association with pelvic ring instability.

OBJECTIVE: To compare dedicated MRI with targeted fluoroscopic guided symphyseal contrast agent injection regarding the assessment of symphyseal cleft signs in men with athletic groin pain and assessment of radiographic pelvic ring instability. METHODS: Sixty-six athletic men were prospectively included after an initial clinical examination by an experienced surgeon using a standardized procedure. Diagnostic fluoroscopic symphyseal injection of a contrast agent was performed. Additionally, standing single-leg stance radiography and dedicated 3-Tesla MRI protocol were employed. The presence of cleft injuries (superior, secondary, combined, atypical) and osteitis pubis was recorded. RESULTS: Symphyseal bone marrow edema (BME) was present in 50 patients, bilaterally in 41 patients and in 28 with an asymmetrical distribution. Comparison of MRI and symphysography was as followed: no clefts: 14 cases (MRI) vs. 24 cases (symphysography), isolated superior cleft sign: 13 vs. 10, isolated secondary cleft sign: 15 vs. 21 cases and combined injuries: 18 vs. 11 cases. In 7 cases a combined cleft sign was observed in MRI but only an isolated secondary cleft sign was visible in symphysography. Anterior pelvic ring instability was observed in 25 patients and was linked to a cleft sign in 23 cases (7 superior cleft sign, 8 secondary cleft signs, 6 combined clefts, 2 atypical cleft injuries). Additional BME could be diagnosed in 18 of those 23. CONCLUSION: Dedicated 3-Tesla MRI outmatches symphysography for purely diagnostic purposes of cleft injuries. Microtearing at the prepubic aponeurotic complex and the presence of BME is a prerequisite for the development of anterior pelvic ring instability. CLINICAL RELEVANCE STATEMENT: For diagnostic of symphyseal cleft injuries dedicated 3-T MRI protocols outmatch fluoroscopic symphysography. Prior specific clinical examination is highly beneficial and additional flamingo view x-rays are recommended for assessment of pelvic ring instability in these patients. KEY POINTS: • Assessment of symphyseal cleft injuries is more accurate by use of dedicated MRI as compared to fluoroscopic symphysography. • Additional fluoroscopy may be important for therapeutic injections. • The presence of cleft injury might be a prerequisite for the development of pelvic ring instability.

Knot tying in arthroplasty and arthroscopy causes lesions to surgical gloves: a potential risk of infection.

PURPOSE: Recent studies have shown that the incidence of glove lesions during arthroscopy is much lower than that during primary and revision arthroplasty. However, the rate of glove damage after knot tying has not yet been systematically recorded. Therefore, the aim of the study was to determine the impact of surgical knot tying on glove integrity. It was hypothesized that knot tying increases the rate of glove damage, especially in arthroscopic surgery, which could be of special relevance in the treatment of rotator cuff tears. METHODS: Gloves that were changed immediately before suturing and only worn during knot tying were investigated for their integrity by means of water tightening test according to EN455. A total of 234 gloves from 40 total hip arthroplasties (THAs), 42 total knee arthroplasties (TKAs) and 36 rotator cuff repairs (RCRs) were collected. A bacterial pass-through test (BPTT) on glove lesions was performed under simulated sterile surgical conditions for 3 surgeons after a wear duration of 45 min. RESULTS: Glove damage by knot tying occurred in 25% of THA, 36.6% of TKA and 25% of RCR surgeries. In THA, the pulling hand (PH) was affected in 46.2%, and the main area of damage (15.4%) was detected on the tip of the middle finger; in TKAs the PH was damaged in 75%, and in RCRs the PH was affected in 66.7%, with most of the lesions (20% each) occurring on the tip of the index finger and the ring finger. The BPTT showed Staphylococcus hominis and Bacillus cereus. CONCLUSION: Intraoperative knot tying causes damage to gloves, which is of special relevance for arthroscopic surgery. Whereas knot tying is only partly responsible for glove damage in arthroplasty, the general rate of glove damage in arthroscopic surgery is low without knot tying. The surgical knot tying process must be understood as a possible damaging impact on the glove. Therefore, single gloving is not recommended, which is especially important in arthroscopic surgery, where double gloving is not yet standard. LEVEL OF EVIDENCE: IV.

All-Arthroscopic Hydrogel-Based Autologous Chondrocyte Transplantation in the Knee Joint: Good Clinical and Magnetic Resonance Imaging Outcome After 24 Months.

PURPOSE: To evaluate subjective and objective clinical and magnetic resonance imaging-based radiologic outcomes after short-term follow-up in patients with focal full-size cartilage lesions of the knee joint treated with all-arthroscopic hydrogel-based autologous chondrocyte transplantation. METHODS: A retrospective study on patients with isolated focal cartilage defects of the knee joint who were treated with arthroscopically conducted matrix-induced autologous chondrocyte transplantation was performed. Clinical scores were assessed at baseline and final follow-up using the Tegner Score, visual analog scale, the International Knee Documentation Committee, and the 5 subscales of the Knee Injury and Osteoarthritis Outcome Score. Magnetic resonance imaging scans of the treated knee joints were evaluated with the updated MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) 2.0 scoring system at follow-up. RESULTS: Twenty-nine consecutive patients were included in the study. Mean time to follow-up was 24.9 ± 1.1 months. Average visual analog scale decreased significantly from 6.5 ± 3.1 preoperatively to 2.3 ± 1.6 at follow-up (P < .0001). Tegner score increased from 3.1 ± 1.3 to 4.3 ± 1.2 (P < .0001) and the International Knee Documentation Committee from 43.8 ± 21.9 to 64.9 ± 18.9 (P < .0001). Also, all Knee Injury and Osteoarthritis Outcome Score subscales displayed significant improvements. Patients showed similar improvements of nearly all clinical scores independent of the defect size. Average MOCART2.0 score was 70.0 ± 13.6 and 20 patients scored ≥70 points. All 8 patients with large defects (>5 cm2) scored ≥75 points. CONCLUSIONS: In this small study, injectable matrix-induced autologous chondrocyte transplantation therapy in the knee joint led to favourable clinical and radiologic short-term results with significant improvements in all clinical scores and MOCART2.0 scores, confirming morphologic integrity of the transplanted chondrocytes. Therefore, this minimally invasive procedure represents a promising operative technique for cartilage regeneration, even for large-diameter lesions. LEVEL OF EVIDENCE: IV, therapeutic case series.

Predictors for an unsuccessful conservative treatment of patients with medial patellar plica syndrome.

INTRODUCTION: In several cases persistent medial knee pain remains after conservative treatment in patients with medial patellar plica syndrome. In recent literature accepted criteria for surgical indication are lacking. In this retrospective study patients after conservative treatment were evaluated to identify predictors for an unsuccessful outcome. MATERIALS AND METHODS: 117 Patients with medial patellar plica syndrome between 2016 and 2019 were retrospectively evaluated. All patients received conservative treatment for three months. Surgery was indicated due to failed conservative treatment (n = 76) with persistent medial knee pain and restriction of activity after 3 months. Preoperative MRI analysis, Lysholm score, pain by the visual analog scale (VAS), postoperative sports participation (RTS) and Tegner activity score were collected at least 12 months after definite treatment. Statistical analysis was performed to evaluate differences between patients with successful and unsuccessful conservative treatment. RESULTS: There were significant differences in the clinical and radiological findings between patients with successful and unsuccessful conservative treatment. Patients with failed conservative treatment showed a significant larger diameter of the medial patellar plica (0.8 ± 0.3 mm vs. 1.6 ± 0.4 mm; p < 0.05) and a significant higher rate of contact of the plica to the adjacent cartilage. Furthermore, these patients reported a significant higher rate of medial knee pain from flexion to extension and snapping symptoms. At final follow-up the patient-reported outcome by means of Lysholm score (96.25 vs. 95.93), RTS (96.2% vs. 97%) and Tegner activity score (6.0 vs. 6.01) was excellent after conservative and surgical treatment. There were no statistical differences in the preoperative and postoperative outcomes between both. CONCLUSIONS: The diameter of a medial patellar plica and contact of the plica to the retropatellar cartilage as well as clinical signs like persistent medial knee pain from flexion to extension with snapping symptoms might be predictors for an unsuccessful conservative treatment and the need for surgical intervention in patients with painful medial patellar plica syndrome.

[Readmission rates of back pain patients after primarily conservative inpatient treatment at a university hospital]. / Wiederaufnahmeraten von Rückenschmerzpatienten an einer Universitätsklinik nach primär konservativer stationärer Therapie.

BACKGROUND: The number of patients receiving inpatient treatment for back pain is increasing, as the current structures of outpatient care cannot meet the demand adequately. Although the infrastructure of the maximum care provider ensures possible emergency care and imaging procedures on the one hand, it is not geared to providing replacement services for outpatient care on the other. OBJECTIVES: Analysis of the readmission rates of primarily conservatively treated inpatients with back pain. MATERIALS AND METHODS: In this retrospective study, the recovery rate of patients with back pain who were admitted as emergency inpatients and treated primarily conservatively as inpatients was investigated within 6 months at a university orthopaedic clinic. The study period was 2 years with a follow-up of 6 months. 413 patients were evaluated. RESULTS: After primarily conservative therapy, 17.9% of the patients were readmitted to hospital. It took 25 (±33.25) days until the first readmission and 25.9 (±31.99) days until the second readmission. Pensioners were admitted to hospital significantly more often but were treated mainly conservatively during their stays; 66.8% of the presentations were emergencies without referral. CONCLUSIONS: Readmission after primarily conservative inpatient treatment is relatively high. In most cases, the return of the patient to outpatient care can be achieved by tight management with a rapid diagnostic procedure and targeted aftercare strategies. The patient may return to outpatient care for surgical treatment or, unplanned, due to failed conservative, outpatient treatment.

A Controlled Trial of Erenumab for Episodic Migraine.

BACKGROUND: We tested erenumab, a fully human monoclonal antibody that inhibits the calcitonin gene-related peptide receptor, for the prevention of episodic migraine. METHODS: We randomly assigned patients to receive a subcutaneous injection of either erenumab, at a dose of 70 mg or 140 mg, or placebo monthly for 6 months. The primary end point was the change from baseline to months 4 through 6 in the mean number of migraine days per month. Secondary end points were a 50% or greater reduction in mean migraine days per month, change in the number of days of use of acute migraine-specific medication, and change in scores on the physical-impairment and everyday-activities domains of the Migraine Physical Function Impact Diary (scale transformed to 0 to 100, with higher scores representing greater migraine burden on functioning). RESULTS: A total of 955 patients underwent randomization: 317 were assigned to the 70-mg erenumab group, 319 to the 140-mg erenumab group, and 319 to the placebo group. The mean number of migraine days per month at baseline was 8.3 in the overall population; by months 4 through 6, the number of days was reduced by 3.2 in the 70-mg erenumab group and by 3.7 in the 140-mg erenumab group, as compared with 1.8 days in the placebo group (P<0.001 for each dose vs. placebo). A 50% or greater reduction in the mean number of migraine days per month was achieved for 43.3% of patients in the 70-mg erenumab group and 50.0% of patients in the 140-mg erenumab group, as compared with 26.6% in the placebo group (P<0.001 for each dose vs. placebo), and the number of days of use of acute migraine-specific medication was reduced by 1.1 days in the 70-mg erenumab group and by 1.6 days in the 140-mg erenumab group, as compared with 0.2 days in the placebo group (P<0.001 for each dose vs. placebo). Physical-impairment scores improved by 4.2 and 4.8 points in the 70-mg and 140-mg erenumab groups, respectively, as compared with 2.4 points in the placebo group (P<0.001 for each dose vs. placebo), and everyday-activities scores improved by 5.5 and 5.9 points in the 70-mg and 140-mg erenumab groups, respectively, as compared with 3.3 points in the placebo group (P<0.001 for each dose vs. placebo). The rates of adverse events were similar between erenumab and placebo. CONCLUSIONS: Erenumab administered subcutaneously at a monthly dose of 70 mg or 140 mg significantly reduced migraine frequency, the effects of migraines on daily activities, and the use of acute migraine-specific medication over a period of 6 months. The long-term safety and durability of the effect of erenumab require further study. (Funded by Amgen and Novartis; STRIVE ClinicalTrials.gov number, NCT02456740 .).

The spectrum of response to erenumab in patients with chronic migraine and subgroup analysis of patients achieving ≥50%, ≥75%, and 100% response.

OBJECTIVE: To assess the efficacy of erenumab across the spectrum of response thresholds (≥50%, ≥75%, 100%) based on monthly migraine days (MMD) reduction in patients with chronic migraine from a 12-week, randomized study (NCT02066415). METHODS: Patients (n = 667) received (3:2:2) placebo or erenumab 70/140 mg once-monthly. The proportion of patients achieving a given response threshold was assessed. A post-hoc analysis was conducted to contextualize the actual treatment benefit in subgroups of patients achieving (or not) specified response thresholds. Outcome measures included MMD, acute migraine-specific medication treatment days (MSMD) and disability. RESULTS: The proportion of patients responding to erenumab exceeded that of placebo at the ≥50% and ≥75% response thresholds. At month 3, 39.9% and 41.2% of patients on erenumab 70 and 140 mg, respectively, achieved ≥50% response versus placebo (23.5%). Similarly, at month 3, 17.0% and 20.9% of patients on erenumab 70 and 140 mg, respectively, achieved ≥75% response versus placebo (7.8%). Compared with the overall erenumab-treated population (change in MMD: -6.6 [both 70 and 140 mg]), ≥50% responders showed MMD reductions of -12.2/-12.5 for 70 mg/140 mg versus -2.6/-2.2 for those not achieving ≥50% response. ≥75% responders showed MMD reductions of -13.9/-14.8 for 70 mg/140 mg versus -5.0/-4.3 for those not achieving ≥75% response. Relative improvements in MSMD and disability were observed in responders versus overall erenumab-treated population. CONCLUSION: For erenumab-treated patients achieving ≥50% response, the actual reduction in MMD was almost twice that of the overall population. These findings provide context for setting realistic expectations regarding actual treatment benefit experienced by patients responding to treatment.

The Spectrum of Response to Erenumab in Patients With Episodic Migraine and Subgroup Analysis of Patients Achieving ≥50%, ≥75%, and 100% Response.

OBJECTIVE: To assess the efficacy of erenumab at the ≥50%, ≥75%, and 100% reduction in monthly migraine days (MMD) response thresholds, using data from the 6-month double-blind treatment phase (DBTP) of the Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention (STRIVE) pivotal clinical trial. METHODS: Enrolled patients with episodic migraine (EM; ≥4 MMD and <15 monthly headache days) were randomized (1:1:1) to erenumab 70 mg (n = 312), erenumab 140 mg (n = 318), or placebo (n = 316) once monthly. We determined the proportions of patients with ≥50%, ≥75% and 100% reduction in MMD over the last 3 months of the STRIVE DBTP (months 4 through 6) and conducted post hoc analyses to contextualize the treatment benefit in patient subgroups achieving, and not achieving, these response thresholds. Outcome measures included changes in MMD, acute migraine-specific medication days (MSMD), and patient-reported outcomes. RESULTS: The proportions of patients with a reduction in MMD from baseline were greater for erenumab than for placebo at all response thresholds. As previously reported for the ≥50% response threshold, 135/312 (43.3%) of patients on erenumab 70 mg and 159/318 (50.0%) on erenumab 140 mg responded, vs 84/316 (26.6%) for placebo. At months 4 through 6, 65/312 (20.8%) and 70/318 (22.0%) of those on erenumab 70 mg and erenumab 140 mg, respectively, achieved ≥75% reductions vs 25/316 (7.9%) on placebo. A reduction of 100% response, which required no migraine days over 3 consecutive months based on observed data, was achieved by 10/312 (3.2%) of patients treated with erenumab 70 mg and 16/318 (5.0%) for erenumab 140 mg, vs 9/316 (2.8%) for placebo. At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early. Meanwhile, 60/312 (19.2%) and 53/318 (16.7%) patients on erenumab 70 and 140 mg, respectively, had no reduction in MMD from baseline in months 4 through 6, compared with 104/316 (32.9%) patients on placebo. CONCLUSIONS: The responses at the ≥50%, ≥75%, and 100% thresholds provide context for establishing realistic patient and physician expectations regarding the magnitude of treatment benefit that may be achieved by patients with EM responding to erenumab (STRIVE, NCT02456740).

[Pitfalls due to manufacturer instructions in modern joint surgery]. / Fallstricke durch Herstellerinstruktionen in der modernen Gelenkchirurgie.

Endoprosthetic implantations require the user to know numerous details of the installation process. Instructions from manufacturers are, therefore, always an essential part of legal proceedings in the event of premature implant failure. In addition to the application steps, the question of the application limits of the implants is also important. Patients' excessive safety expectations of the manufacturer or the medical user can also lead to avoidable product liability. Overall, there is a need to define standards and minimum requirements in package inserts and instructions, even if these can only be developed in accordance with the current state of science.

Treatment patterns and characteristics of patients with migraine in Japan: A retrospective analysis of health insurance claims data.

OBJECTIVE: To describe treatment patterns of migraine patients in the Japan Medical Data Center (JMDC) database. METHODS: Patients aged ≥18 years with ≥1 inpatient or ≥2 outpatient migraine diagnoses, ≥1 outpatient diagnosis and ≥1 migraine-specific acute treatment (triptan or ergotamine), or ≥2 migraine-specific acute treatments from 1 May 2011 to 30 April 2014 were identified. Patients were required to be enrolled in a health plan for ≥1 year before and after the index date. The first migraine diagnosis or acute treatment defined the index date. Patients were stratified by the migraine treatments observed after the index date (i.e. migraine-specific acute treatment only [AT], prophylactic with or without migraine-specific acute treatment [PT], or no treatment [NT]) and described regarding the first migraine treatment regimen and subsequent treatment patterns during up to 1 year of follow-up. RESULTS: A total of 16,443 patients met the eligibility criteria (9873 AT, 3022 PT, and 3548 NT). AT patients had mean (SD) 10.3 (20.5) acute treatment days during 1-year follow-up, and 81.9% received triptans. When assessing the first migraine treatment regimen during follow-up in PT patients, 29.2% received prophylactic treatment only and 51.7% received both acute and prophylactic treatment. Calcium-channel blockers with or without concomitant triptans (34.4%) were the most common first regimen. Approximately 62.2% discontinued initial prophylactic treatment after an average of 61.2 days (SD = 65.3) of persistent treatment. Among discontinuers, 15.2% reinitiated original treatment and 7.0% switched treatment post-discontinuation within a year, while the remaining patients did not receive prophylactic therapy following discontinuation. CONCLUSIONS: Among Japanese migraine patients, prophylactic use was low and associated with a high rate of discontinuation following a brief treatment period. Many patients reinitiated or switched treatment following discontinuation, while a significant proportion of patients remained discontinued from prophylactic therapy, suggesting a high unmet need.

Efficacy and safety of erenumab (AMG334) in episodic migraine patients with prior preventive treatment failure: A subgroup analysis of a randomized, double-blind, placebo-controlled study.

BACKGROUND: Erenumab was effective and well tolerated in a pivotal clinical trial of episodic migraine that included subjects both naïve to, and those who had failed, previous preventives. Here we evaluated the efficacy and safety of erenumab (70 mg or 140 mg) versus placebo in the subgroup of patients who had previously failed preventive treatment(s): ≥1 or ≥2 prior failed migraine preventive categories, and in patients who had never failed. METHODS: Prespecified subgroup analyses evaluated change from baseline to months 4-6 (the primary endpoint of the blinded study phase) in monthly migraine days, achievement of ≥50% and ≥75% reduction in monthly migraine days, and change from baseline in acute migraine-specific medication days. Adverse events were also evaluated. RESULTS: Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days at months 4-6 (treatment difference versus placebo [95% CI], never failed subgroup: -0.9 [-1.5, -0.3] for 70 mg and -1.3 [-1.9, -0.7] for 140 mg; ≥1 prior failed medication categories subgroup: -2.0 [-2.8, -1.2] for 70 mg and -2.5 [-3.4, -1.7] for 140 mg; ≥2 prior failed medication categories subgroup: -1.3 [-2.6, 0.0] for 70 mg and -2.7 [-4.0, -1.4] for 140 mg). Similar results were observed in the monthly acute migraine-specific medication days endpoint, and in the achievement of ≥50% and ≥75% reduction in monthly migraine days. For the ≥50% reduction in monthly migraine day endpoint, placebo response in the no prior treatment failed group was 32.6%, in the ≥1 failed treatment 17.5%, and in the ≥2 failed treatments 11.1%. CONCLUSION: Erenumab showed consistent efficacy in episodic migraine patients who had failed prior preventive treatments and was well tolerated across subgroups. The data suggest prior patients with prior treatment failures have lower placebo response rates.

A Randomized Phase 2 Study of Erenumab for the Prevention of Episodic Migraine in Japanese Adults.

OBJECTIVE: A phase 2, double-blind, placebo-controlled study to evaluate the efficacy and safety of erenumab for the prevention of episodic migraine in Japanese patients was conducted. BACKGROUND: Previous global clinical studies have demonstrated the efficacy of erenumab in the prevention of migraine. METHODS: Patients were randomized to placebo or erenumab 28, 70, or 140 mg administered subcutaneously once per month for 6 months. The primary endpoint was change from baseline in mean monthly migraine days over months 4-6 of the double-blind treatment phase. Secondary endpoints included the proportion of patients achieving ≥50% reduction from baseline in mean monthly migraine days (≥50% response) and change from baseline in mean monthly acute migraine-specific medication treatment days (MSMD) and mean Headache Impact Test (HIT-6™) scores. Efficacy outcomes were also determined at months 1, 2, and 3. RESULTS: Four hundred and seventy five patients were randomized 2:1:2:2 to placebo and erenumab 28, 70, and 140 mg, respectively. Greater reductions in monthly migraine days were observed for erenumab vs placebo with differences of -1.25 (95% CI: -2.10 to -0.41; P = .004), -2.31 (95% CI: -3.00 to -1.62; P < .001), and -1.89 (95% CI: -2.58 to -1.20; P < .001) days for erenumab 28, 70, and 140 mg. The odds of having a ≥50% response were 3.2, 5.6, and 4.7 times greater for erenumab 28 mg (95% CI: 1.30-7.88; P = .009), 70 mg (95% CI: 2.60-12.06; P < .001), and 140 mg (95% CI: 2.24-9.99; P < .001) than for placebo. Greater reductions from baseline in mean acute monthly MSMD were observed for erenumab vs placebo with differences of -1.07 (95% CI: -1.80 to -0.35; P = .004), -2.07 (95% CI: -2.66 to -1.49; P < .001), and -2.04 (95% CI: -2.63 to -1.45; P < .001) days for erenumab 28, 70, and 140 mg. Erenumab 70 and 140 mg also resulted in greater improvements in HIT-6™ scores. The safety profile was similar across treatment groups. The most common adverse event was nasopharyngitis, which occurred in 29.4% of patients in the placebo group and 28.9%-33.3% of patients in the erenumab groups. CONCLUSION: Monthly subcutaneous injections of erenumab 70 mg demonstrated statistically significant and numerically maximal efficacy with a favorable safety profile, suggesting that erenumab is a potential new therapy for migraine prevention in Japan.

Impact of compression stockings on leg swelling after arthroscopy - a prospective randomised pilot study.

BACKGROUND: Post-operative limb swelling may negatively affect the outcome of arthroscopic surgery and prolong rehabilitation. The aim of this pilot study was to evaluate the effect of compression stockings versus no compression on post-operative swelling and pain in the early post-operative phase. METHODS: A single-centre, randomised controlled trial was performed. Patients who underwent minor knee arthroscopy were randomised to wear class II compression stockings (23-32 mmHg) (CS) or no compression stockings (NCS) immediately post-operatively for ten days. All patients received low molecular weight heparin (LMWH) at prophylactic dosage. The primary outcome variable was post-operative swelling of the limb, quantified by using an optical 3D measurement system (Bodytronic© 600). Pain was rated on a visual analogue scale (VAS). From a total of 76 patients assessed, 19 patients were eligible for final analysis. The trial followed the CONSORT criteria, was registered at clinicaltrial.gov and approved by the local ethics committee. RESULTS: The circumference at the middle thigh (cF) was significantly different between groups at day 10 (p = 0.032; circumference - 1.35 ± 2.15% (CS) and + 0.79 ± 3.71% (NCS)). Significant differences were also noted around the knee (cD) at day 10 (p = 0.026) and a significant trend at cD and at the mid lower leg (cB1) at day 4. The volume of the thigh was also different with marked difference between days 1 and 4 between the two groups (p = 0.021; volume + 0.54 ± 2.03% (CS) and + 4.17 ± 4.67 (NCS)). Pain was lower in compression group (not statistically significant). CONCLUSIONS: Post-operative limb swelling can be reduced significantly by wearing compression stockings in the early post-operative phase when compared to not wearing stockings. This may improve the rehabilitation process after arthroscopic surgery. The optimal duration of compression therapy seems to be between three and ten days. TRIAL REGISTRATION: clinicaltrials.gov ( NCT02096562 , date of registration 11.11.2013).

Evaluation of Rock Climbing Related Injuries in Older Athletes.

INTRODUCTION: With the growing enthusiasm from people of all ages about rock climbing and bouldering, adaptions and medical conditions of the older athlete have become increasingly important. We aimed to analyze injury demographics, distribution, and severity for the older rock-climbing athlete. METHODS: During a 3-y period, we performed a single-center injury surveillance in athletes ≥35 y of age presenting with rock climbing-related injuries or complaints. A standard questionnaire and examination protocol were conducted. RESULTS: A total of 198 patients (age 44.2±7.1 [35-77] y) (mean±SD, with range) with 275 independent injuries were recorded. Ninety percent of all injuries affected the upper extremity, 6% the lower extremity, and 4% other body regions. The Union Internationale des Associations d'Alpinisme injury scores were 2.0±0.3 (1-4), and no fatalities occurred. Acute injuries were observed in 32% and overuse injuries in 68% of all injuries. Among the overuse injuries, 47% were classified as degenerative overuse conditions. Athlete age did not significantly correlate with the development of overuse injuries and UIAA injury score, but subgroup analysis showed a weak correlation of the climber age with the development of degenerative conditions (P<0.05). The leading diagnosis of degenerative conditions was subacromial impingement syndrome of the shoulder. CONCLUSIONS: Compared to younger athletes, older rock climbers demonstrate a higher proportion of overuse injuries, especially degenerative conditions. Profound knowledge of climbing injuries patterns and conditions in older rock climbers is crucial to prevent injuries among all age groups and to decrease the number of degenerative injuries.

Efficacy and safety of erenumab (AMG334) in chronic migraine patients with prior preventive treatment failure: A subgroup analysis of a randomized, double-blind, placebo-controlled study.

Background Erenumab was effective and well tolerated in a pivotal clinical trial of chronic migraine. Here, we evaluated efficacy and safety of monthly erenumab (70 mg or 140 mg) versus placebo in the subgroup of patients who had previously failed preventive treatment(s) (≥ 1, ≥ 2 prior failed medication categories) and in patients who had never failed. Methods Subgroup analyses evaluated change from baseline in monthly migraine days; achievement of ≥ 50% and ≥ 75% reduction in monthly migraine days; and change in monthly acute migraine-specific medication days. Adverse events were evaluated for each subgroup. Results Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days (primary endpoint) at Month 3 (treatment difference [95% CI], never failed subgroup: -2.2 [-4.1, -0.3] for 70 mg and -0.5 [-2.4, 1.5] for 140 mg; ≥ 1 prior failed medication categories subgroup: -2.5 [-3.8, -1.2], for 70 mg and -3.3 [-4.6, -2.1] for 140 mg; ≥ 2 prior failed medication categories subgroup: -2.7 [-4.2, -1.2], for 70 mg and -4.3 [-5.8, -2.8] for 140 mg). Similar results were observed in the monthly acute migraine-specific medication days endpoint, and in the achievement of ≥ 50% and ≥ 75% reduction in monthly migraine days. There were no new or unexpected safety issues. Conclusion Erenumab showed consistent efficacy in chronic migraine patients who had failed prior preventive treatments and was well tolerated across subgroups.

ARISE: A Phase 3 randomized trial of erenumab for episodic migraine.

Background Calcitonin gene-related peptide plays an important role in migraine pathophysiology. Erenumab, a human monoclonal antibody that inhibits the calcitonin gene-related peptide receptor, is being evaluated for migraine prevention. Methods In this randomized, double-blind, placebo-controlled, phase 3 study, 577 adults with episodic migraine were randomized to placebo or 70 mg erenumab; 570 patients were included in efficacy analyses. Primary endpoint was change in monthly migraine days. Secondary endpoints were ≥50% reduction in monthly migraine days, change in acute migraine-specific medication treatment days, and ≥5-point reduction in Physical Impairment and Impact on Everyday Activities domain scores measured by the Migraine Physical Function Impact Diary. All endpoints assessed change from baseline at month 3. Results Patients receiving erenumab experienced -2.9 days change in monthly migraine days, compared with -1.8 days for placebo, least-squares mean (95% CI) treatment difference of -1.0 (-1.6, -0.5) ( p < 0.001). A ≥ 50% reduction in monthly migraine days was achieved by 39.7% (erenumab) and 29.5% (placebo) of patients (OR:1.59 (95% CI: 1.12, 2.27) ( p = 0.010). Migraine-specific medication treatment days were reduced by -1.2 (erenumab) and -0.6 (placebo) days, a treatment difference of -0.6 (-1.0, -0.2) ( p = 0.002). The ≥5-point reduction rates in Migraine Physical Function Impact Diary - Physical Impairment were 33.0% and 27.1% (OR:1.33 (0.92, 1.90) ( p = 0.13) and in Migraine Physical Function Impact Diary - Everyday Activities were 40.4% and 35.8% (OR:1.22 (0.87, 1.71) ( p = 0.26). Safety and adverse event profiles of erenumab were similar to placebo. Most frequent adverse events were upper respiratory tract infection, injection site pain, and nasopharyngitis. Conclusions As a preventive treatment of episodic migraine, erenumab at a dosage of 70 mg monthly significantly reduced migraine frequency and acute migraine-specific medication use. (Funded by Amgen). Trial registration ClinicalTrials.gov, NCT02483585.

Migraine-related disability, impact, and health-related quality of life among patients with episodic migraine receiving preventive treatment with erenumab.

Background We evaluated the effect of erenumab, a fully human monoclonal antibody that inhibits the canonical calcitonin gene-related peptide receptor, on migraine-related disability, impact, and health-related quality of life among patients with episodic migraine. Methods Patients enrolled in a phase 3, 6-month, double-blind, placebo-controlled study of once-monthly erenumab 70 and 140 mg for migraine prevention (STRIVE) used an eDiary during the baseline and double-blind treatment phases to complete validated, specific questionnaires, including the modified (monthly) Migraine Disability Assessment Questionnaire; Headache Impact Test; and Migraine-Specific Quality of Life Questionnaire-role function-restrictive (MSQ-RFR), -role function-preventive (MSQ-RFP), and -emotional function (MSQ-EF). Results A total of 955 patients were randomized to receive erenumab 70 mg (n = 317), erenumab 140 mg (n = 319), or placebo (n = 319). Erenumab versus placebo resulted in significantly greater improvements in all patient-reported outcomes; changes from baseline were numerically higher with 140 mg erenumab. Improvements occurred rapidly and were maintained over 6 months of treatment. Between-group differences from placebo over months 4-6 for the 70- and 140-mg dose groups were, respectively, -2.1 and -2.8 for modified (monthly) Migraine Disability Assessment Questionnaire, -2.1 and -2.3 for Headache Impact Test, 5.1 and 6.5 for MSQ-RFR, 4.2 and 5.4 for MSQ-RFP, and 5.2 and 6.7 for MSQ-EF ( p < 0.001 for all). Erenumab also significantly reduced the proportion of patients with severe and very severe migraine-related disability and increased the proportion of patients with clinically meaningful improvements in migraine-related impact and health-related quality of life. Conclusion Erenumab reduced migraine disability and impact and improved patients' health-related quality of life, reinforcing its role as a promising new therapy for migraine prevention.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Erenumab on Exercise Time During a Treadmill Test in Patients With Stable Angina.

OBJECTIVE: To determine the potential impact of erenumab, a human anti-calcitonin gene-related peptide (CGRP) receptor monoclonal antibody, on total exercise time (TET), time to exercise-induced angina, and ST depression in a double-blind, placebo-controlled study in patients with stable angina due to documented coronary artery disease. BACKGROUND: The relative importance of the CGRP receptor pathway during myocardial ischemia has not been established. METHODS: An exercise treadmill test was conducted following a single IV infusion of erenumab 140 mg or placebo. The primary endpoint was the change from baseline in exercise duration as measured by TET with a noninferiority margin of -90 seconds. Safety follow-up visits occurred through week 12. Eighty-eight participants were included in the analysis. RESULTS: LS mean (SE) change in TET was -2.9 [14.8] seconds in the erenumab group and 8.1 [14.4] seconds in placebo; adjusted mean (90% CI) treatment difference was -11.0 (-44.9, 22.9) seconds. The CI lower bound (-44.9 sec) did not reach pre-defined non-inferiority margin of -90 seconds, demonstrating that TET change from baseline in the erenumab group was non-inferior to placebo. There was no difference in time to exercise-induced angina in erenumab and placebo groups (median [90% CI] time of 500 [420, 540] vs 508 [405, 572] seconds; hazard ratio [90% CI]: 1.11 [0.73, 1.69], P = .69) or time to onset of ≥1 mm ST-segment depression (median [90% CI] time of 407 [380, 443] vs 420 [409,480] seconds; hazard ratio [95% CI]: 1.14 [0.76, 1.69], P = .59). Adverse events were reported by 27% and 32% of patients in erenumab and placebo groups. CONCLUSIONS: Erenumab did not adversely affect exercise time in a high cardiovascular risk population of patients, supporting that inhibition of the canonical CGRP receptor does not worsen myocardial ischemia.

Migraine Prophylaxis and Acute Treatment Patterns Among Commercially Insured Patients in the United States.

OBJECTIVES: To describe prophylactic and acute medication treatment patterns, including timing, medication type, and duration of use in migraine patients initiating prophylaxis. BACKGROUND: Patients with migraine can be treated with acute and prophylactic therapies. Current treatment options for migraine prophylaxis are associated with poor tolerability and low adherence and persistence. METHODS: This retrospective cohort study used the Truven Health Analytics MarketScan® Research Databases to identify adults in the United States with a migraine diagnosis who initiated migraine prophylactic medication (index event) between January 1, 2008, and December 31, 2011. Prescribed prophylactic medications evaluated included topiramate, beta-blockers, and tricyclic antidepressants. Patients were required to have 12 months of pre- and post-index continuous enrollment. Patient characteristics, migraine-specific prescribed prophylactic treatment patterns (including gaps in therapy, treatment switches, and additions of index medications), and prescribed acute medication utilization were assessed. RESULTS: The study population comprised 107,122 patients, with 52,275 (49%) initiating topiramate, 22,658 (21%) initiating beta-blockers, and 32,189 (30%) initiating tricyclic antidepressants. Mean (SD) age was 41 (12) years and 83% were female. Persistence with migraine prophylactic medication was low; 81% of patients had gaps of >90 days in their migraine prophylaxis in the first year. The gap in therapy occurred early in treatment (mean, 95 days), and only 10% of patients restarted prophylactic therapy within that year. Switching from index medication to another prophylactic medication or adding prophylaxis was uncommon (13% and 5%, respectively). One year after initiating prophylaxis, 65% of patients were not receiving any prophylactic therapies. Most patients initiating migraine prophylaxis also utilized acute treatments (81%); opioid use was more frequent than triptan use (53% vs 48%) and was common (40%) among patients without other chronic pain conditions (eg, arthritis, fibromyalgia, and lower back pain). CONCLUSION: Patients with migraine who initiated prophylactic therapy had poor persistence with early gaps in therapy, were unlikely to switch prophylactic treatments, and most discontinued prophylaxis by the end of the first year.

Impact of the patella height on the strain pattern of the medial patellofemoral ligament after reconstruction: a computer model-based study.

PURPOSE: Medial patellofemoral ligament (MPFL) reconstruction is a key procedure for treating patellofemoral instability. However, controversy exists regarding the correct graft placement in different patellar heights. Therefore, our study aimed to investigate the influence of patellar height on MPFL insertion points. METHODS: Strain patterns of the reconstructed MPFL were calculated using a dynamic musculoskeletal multibody simulation. Numerous patellar (proximal, central, distal) and femoral attachment sites (around the radiological point according to Schöttle) were analysed in the presence of different patella heights [Insall-Salvati (IS) indices 0.74, 1.0, 1.5] during dynamic knee flexion from 0° to 120°. RESULTS: The reconstructed MPFL showed an almost isometric behaviour at the anatomic insertion (IS 1.0). Slight variation (<5 mm) around the ideal femoral insertion point resulted in only small changes in MPFL tension. However, a displacement of 10 mm led to a significant increase in MPFL tension, especially in the more anteriorly/proximally located femoral attachment points. Depending on the patella height, there exists an area of absolute isometry of the MPFL (length change <3 %) on the femoral condyle, which did not necessarily coincide exactly with the radiological point, but was located within a radius of 5 mm around it. CONCLUSIONS: When reconstructed in the radiological femoral insertion point, MPFL strain patterns were only slightly affected by different patella heights (IS 0.74-1.5) suggesting that MPFL reconstruction could be safely performed using the radiological insertion. However, in case of a patella alta (IS 1.5), a slightly more proximal femoral insertion is beneficial for the biomechanical behaviour of the reconstructed MPFL.