Fixation Using Alternative Implants for the Treatment of Hip Fractures

Objectives: To conduct a pilot trial for the Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) protocol to assess feasibility of a definitive trial. Design: Pilot trial. Setting: Twenty-five clinical sites across North America and Australia were initiated, but enrolment occurred in only 15 North American sites. Patients/participants: Ninety-one randomized adults aged 18 to 60 years with a femoral neck fracture requiring surgical fixation. Intervention: Eligible patients were randomized to receive surgical treatment (sliding hip screw or cancellous screws) AND nutritional supplementation (4000 IU of vitamin D or placebo) for 6 months postfracture. Main outcome measurements: Feasibility outcomes included: clinical site initiation, participant enrolment rate, proportion of participants with complete 12-month follow-up, level of data quality, and rate of protocol adherence (number of randomization errors, crossovers between treatment groups, and daily supplementation adherence). Results: Eighty-six of 91 participants randomized into the pilot trial from 15 North American hospitals were deemed eligible. Four of five primary feasibility criteria were not achieved as we were unable to initiate clinical sites outside of North America and Australia due to feasibility constraints, slow participant enrolment (60 participants recruited over 36 mo), low adherence with daily nutritional supplementation at the 6-week (72.1%), 3-month (60.5%), and 6-month (54.7%) follow-up visits, and a high loss to follow-up rate of 22.1% at 12 months. Conclusions: Despite not meeting key feasibility criteria, we increased our knowledge on the logistics and anticipated barriers when conducting vitamin D supplementation trials in this trauma population, which can be used to inform the design and conduct of future trials on this topic

Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Clinical Outcomes of a Multicenter 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients

Objective: To assess whether the fixation method and vitamin D supplementation affect the risk of patient-important outcomes within 12 months of injury in nongeriatric femoral neck fracture patients. Design: A pilot factorial randomized controlled trial. Setting: Fifteen North American clinical sites. Participants: Ninety-one adults 18–60 years of age with a femoral neck fracture requiring surgical fixation. Intervention: Participants were randomized to a surgical intervention (sliding hip screw or cancellous screws) and a vitamin D intervention (vitamin D3 4000 IU daily vs. placebo for 6 months). Main Outcome Measurements: The primary clinical outcome was a composite of patient-important complications (reoperation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion). Secondary outcomes included fracture-healing complications and radiographic fracture healing. Results: Eighty-six participants with a mean age of 41 years were included. We found no statistically significant difference in the risk of patient-important outcomes between the surgical treatment arms (hazard ratio 0.90, 95% confidence interval 0.40–2.02, P = 0.80) and vitamin D supplementation treatment arms (hazard ratio 0.96, 95% confidence interval 0.42–2.18, P = 0.92). Conclusions: These pilot trial results continue to describe the results of current fixation implants, inform the challenges of improving outcomes in this fracture population, and may guide future vitamin D trials to improve healing outcomes in young fracture populations. Although the pilot trial was not adequately powered to detect treatment effects, publishing these results may facilitate future meta-analyses on this topic. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence

Subsequent Surgery After Revision Anterior Cruciate Ligament Reconstruction: Rates and Risk Factors From a Multicenter Cohort

BACKGROUND: While revision anterior cruciate ligament reconstruction (ACLR) can be performed to restore knee stability and improve patient activity levels, outcomes after this surgery are reported to be inferior to those after primary ACLR. Further reoperations after revision ACLR can have an even more profound effect on patient satisfaction and outcomes. However, there is a current lack of information regarding the rate and risk factors for subsequent surgery after revision ACLR. PURPOSE: To report the rate of reoperations, procedures performed, and risk factors for a reoperation 2 years after revision ACLR. STUDY DESIGN: Case-control study; Level of evidence, 3. METHODS: A total of 1205 patients who underwent revision ACLR were enrolled in the Multicenter ACL Revision Study (MARS) between 2006 and 2011, composing the prospective cohort. Two-year questionnaire follow-up was obtained for 989 patients (82%), while telephone follow-up was obtained for 1112 patients (92%). If a patient reported having undergone subsequent surgery, operative reports detailing the subsequent procedure(s) were obtained and categorized. Multivariate regression analysis was performed to determine independent risk factors for a reoperation. RESULTS: Of the 1112 patients included in the analysis, 122 patients (11%) underwent a total of 172 subsequent procedures on the ipsilateral knee at 2-year follow-up. Of the reoperations, 27% were meniscal procedures (69% meniscectomy, 26% repair), 19% were subsequent revision ACLR, 17% were cartilage procedures (61% chondroplasty, 17% microfracture, 13% mosaicplasty), 11% were hardware removal, and 9% were procedures for arthrofibrosis. Multivariate analysis revealed that patients aged <20 years had twice the odds of patients aged 20 to 29 years to undergo a reoperation. The use of an allograft at the time of revision ACLR (odds ratio [OR], 1.79; P = .007) was a significant predictor for reoperations at 2 years, while staged revision (bone grafting of tunnels before revision ACLR) (OR, 1.93; P = .052) did not reach significance. Patients with grade 4 cartilage damage seen during revision ACLR were 78% less likely to undergo subsequent operations within 2 years. Sex, body mass index, smoking history, Marx activity score, technique for femoral tunnel placement, and meniscal tearing or meniscal treatment at the time of revision ACLR showed no significant effect on the reoperation rate. CONCLUSION: There was a significant reoperation rate after revision ACLR at 2 years (11%), with meniscal procedures most commonly involved. Independent risk factors for subsequent surgery on the ipsilateral knee included age <20 years and the use of allograft tissue at the time of revision ACLR

Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials

An amendment to this paper has been published and can be accessed via the original article

Factors Associated with Revision Surgery after Internal Fixation of Hip Fractures

Background: Femoral neck fractures are associated with high rates of revision surgery after management with internal fixation. Using data from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial evaluating methods of internal fixation in patients with femoral neck fractures, we investigated associations between baseline and surgical factors and the need for revision surgery to promote healing, relieve pain, treat infection or improve function over 24 months postsurgery. Additionally, we investigated factors associated with (1) hardware removal and (2) implant exchange from cancellous screws (CS) or sliding hip screw (SHS) to total hip arthroplasty, hemiarthroplasty, or another internal fixation device. Methods: We identified 15 potential factors a priori that may be associated with revision surgery, 7 with hardware removal, and 14 with implant exchange. We used multivariable Cox proportional hazards analyses in our investigation. Results: Factors associated with increased risk of revision surgery included: female sex, [hazard ratio (HR) 1.79, 95% confidence interval (CI) 1.25-2.50; P = 0.001], higher body mass index (fo

SYLOS lasers – the frontier of few-cycle, multi-TW, kHz lasers for ultrafast applications at extreme light infrastructure attosecond light pulse source

The extreme light infrastructure attosecond light pulse source offers beamtime for users of various attosecond and particle sources driven by versatile laser systems. Here we report on the state of the art of a few-cycle, multi-TW, 1kHz repetition rate laser system, now fully operational in the facility. The system is based on four stages of optical parametric amplifiers (OPAs) pumped by a total of 320mJ, 80ps frequency-doubled Nd:YAG laser pulses. All OPA stages utilize double crystal configuration, which design has been also confirmed by model calculations. The 1kHz SYLOS 2 system produces 32mJ laser pulses around a central wavelength of 891nm with 6.6fs (<2.3 optical cycles) pulse duration exceeding the peak power of 4.8 TW on a daily basis. The recorded best pulse duration is 6.3fs, which corresponds to 2.12 cycles and 5.1 TW peak power. During long-term (24h) performance tests, energy stability of 1.2%, carrier-envelope phase (CEP) stability of 210mrad, and pointing stability of 0.4 mu rad were demonstrated, while the Strehl ratio of the beam is kept above 0.75. In order to help the alignment of all the different experiments at the facility and to reduce the workload on SYLOS 2 system, a second laser system has been developed. The so-called SYLOS Experimental Alignment (SEA) laser mimicks the performance of the SYLOS 2 laser, but at a repetition rate two orders of magnitude lower and without CEP-stabilization. The three single-crystal OPA stages of the SEA laser provide 42mJ pulse energy for the users, while having energy stability of 0.87% and sub-13fs pulse duration at a repetition rate ranging from a single shot up to 10Hz

A Multicenter Randomized Control Trial Comparing a Novel Intramedullary Device (InterTAN) Versus Conventional Treatment (Sliding Hip Screw) of Geriatric Hip Fractures

Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. Objectives: To compare outcomes in elderly patients with intertrochanteric hip fractures treated with either the sliding hip screw (SHS) or InterTAN intramedullary device (IT). Design: Prospective, randomized, multicenter clinical trial. Setting: Five level 1 trauma centers. Patients: Two hundred forty-nine patients 55 years of age or older with AO/OTA 31A1 (43) and OA/OTA 31A2 (206) fractures were prospectively enrolled and followed for 12 months. Intervention: Computer generated randomization to either IT (n = 123) or SHS (n = 126). Main Outcome Measurements: The Functional Independence Measure (FIM) and the Timed Up and Go test (TUG) were used to measure function and motor performance. Secondary outcome measures included femoral shortening, complications, and mortality. Results: Demographics, comorbidities, preinjury FIM scores and TUG scores were similar between groups. Patients (17.2%) who received an IT had limb shortening greater than 2 cm compared with 42.9% who received an SHS (P \u3c 0.001). To determine the importance of preinjury function and fracture stability, we analyzed the subgroup of patients with the ability to walk 150 m independently preinjury and an OA/OTA 31A-2 fracture (n = 70). In this subgroup, patients treated with SHS had greater shortening and demonstrated poorer FIM and TUG scores compared with patients treated with an IT. Conclusions: Overall, most patients with intertrochanteric femur fractures can expect similar functional results whether treated with an intramedullary or extramedullary device. However, active, functional patients have an improved outcome when the InterTAN is used to treat their unstable intertrochanteric fracture. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence