Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience

Contains fulltext : 110505.pdf (publisher's version ) (Open Access)BACKGROUND: Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. METHODS: Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. RESULTS: Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217). CONCLUSIONS: In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00761813

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

Bioabsorbable Versus Metallic Screw Fixation for Tibiofibular Syndesmotic Ruptures: A Meta-Analysis

Ankle fractures with syndesmotic rupture require operative treatment. In most cases, this consists of fixation of the tibiofibular joint with 1 or more screws. Bioabsorbable screws are used for the same purpose but have the advantage that screw removal is unnecessary. The aim of the present study was to compare the results of bioabsorbable and metallic syndesmotic screws. A systematic search was performed in the Ovid MEDLINE electronic database and Google Scholar. Three randomized controlled trials and one comparison study, with 260 patients, were included. The experimental group consisted of patients with syndesmotic injuries treated with bioabsorbable screws versus the control group (patients treated with metallic screws). The primary outcomes were complications and wound infections. No statistically significant difference was demonstrable in the overall number of complications between the 2 groups. In the group of patients with a bioabsorbable screw, 32 of 137 (23.4%) experienced a complication versus 7 of 123 patients (5.7%) with a metallic screw. Data on wound-related complications showed no statistically significant difference, 19.7% versus 5.7%. The average maximum range of motion in both groups was comparable. Bioabsorbable syndesmotic screws and metallic syndesmotic screws were comparable with respect to the incidence of complications and range of motion. However, the absolute number of complications was greater with bioabsorbable screw

Intraobserver and interobserver variability in diagnosing scapholunate dissociation by cineradiography

To evaluate the intraobserver and interobserver variability in diagnosing scapholunate dissociation (SLD) by wrist cineradiography. A musculoskeletal radiologist, hand surgeon, and trauma surgeon assessed the records of 50 consecutive wrist cineradiographies performed in 25 patients. Fluoroscopy was performed on the unaffected and affected wrist and consisted of radiographer-controlled passive flexion-extension and passive radial-ulnar deviation in both posteroanterior and lateral projections. To determine the intraobserver variability, the 3 reviewers reassessed all wrist cineradiographies 6 months after their first assessment. The kappa coefficient for interobserver agreement was calculated using the jackknife method. The Cohen kappa was used to assess intraobserver variability. The interobserver variability for diagnosing SLD by cineradiography was excellent (κ = 0.84). The intraobserver variability for the hand surgeon was excellent (κ = 0.80), and was good for the radiologist (κ = 0.72) and the trauma surgeon (κ = 0.76). Cineradiography is a promising and helpful, noninvasive tool for diagnosing SLD. It is widely available and has relatively low costs. Conventional radiographs remain essential in the primary workup for suspected SLD. However, we recommend cineradiography when an SLD is clinically suspected. Diagnostic II

Rerupture rate after early weightbearing in operative versus conservative treatment of Achilles tendon ruptures: a meta-analysis

Whether Achilles tendon rupture benefits from surgery or conservative treatment remains controversial. Moreover, the outcome can be influenced by the rehabilitation protocol. The goal of the present meta-analysis was to compare the rerupture rate after surgical repair of the Achilles tendon followed by weightbearing within 4 weeks versus conservative treatment with weightbearing within 4 weeks. In addition, a secondary analysis was performed to compare the rerupture rates in patients who started weightbearing after 4 weeks. Seven randomized controlled trials published from 2001 to 2012, with 576 adult patients, were included. The primary outcome measure was the rerupture rate. The secondary outcomes were minor and major complications other than rerupture. In the early weightbearing group, 7 of 182 operatively treated patients (4%) experienced rerupture versus 21 of 176 of the conservatively treated patients (12%). A secondary analysis of the patients treated with late weightbearing showed a rerupture rate of 6% (7 of 108) for operatively treated patients versus 10% (11 of 110) for conservatively treated patients. The differences concerning the rerupture rate in both groups were not statistically significant. No differences were found in the occurrence of minor or major complications after early weightbearing in both patient groups. In conclusion, we found no difference in the rerupture rate between the surgically and nonsurgically treated patients followed by early weightbearing. Weightbearing after 4 weeks also resulted in no differences in the rupture rate in the surgical versus conservatively treated patients. However, surgical treatment was associated with a twofold greater complication rate than conservative treatmen

The effect of postoperative wound infections on functional outcome following intra-articular calcaneal fractures

High rates of postoperative wound infections (POWI) are reported following the operative treatment of calcaneal fractures. This leads to additional therapy, prolonged hospital stay, burden for patients and increased costs. The primary aim of this study is to evaluate the effect of POWI following the extended lateral approach of displaced intra-articular calcaneal fractures on functional outcome. Secondary aims are assessment of health-related quality of life and patient satisfaction. All consecutive adult patients with a calcaneal fracture treated between 2000 and 2011 with open reduction and internal fixation through an extended lateral approach were retrospectively included and sent a questionnaire. Functional outcome was measured using the Foot Function Index (FFI, best score 0 points) and the American Orthopaedic Foot and Ankle Society (AOFAS, best score 100 points) hindfoot score. The EuroQOL-5D was used for quality of life (QOL) and a Visual Analogue Scale (VAS, best score 10 points) for overall patients satisfaction. Of 135 eligible patients, 94 returned the questionnaire (response rate 70 %). The median FFI was 12 points (IQR 3-33) and AOFAS 79 points (IQR 61-90). The FFI and AOFAS were, respectively, 17 and 9 points higher in favour of patients without POWI (n = 69) compared to patients with POWI (n = 25). Albeit large differences, they were not statistically significant given the current number of patients. Patients without POWI scored better on all health-related aspects of QOL in the EQ-5D, but this did not reach statistical significance. However, the VAS on overall patient satisfaction did show a statistically significant difference of 1.3 points (9.0 vs 7.7; p = 0.01) in favour of patients without POWI. Importantly, a clinically relevant difference was found with the FFI as the estimated minimal clinical important difference of the FFI is 10 points. Our results implicate that postoperative wound infection leads lower functional outcome scores following calcaneal fracture surgery, but no statistical significance was reached. In addition, patients do not report significant worse QOL or physical impairment. Overall patient satisfaction measured by a VAS was significantly lower in case of a POWI, reflecting the burden caused by a wound complicatio