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Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study.

ABSTRACT: The role of low-intensity pulsed ultrasound (LIPUS) in the management of fractures remains controversial. The purpose of this study was to assess the feasibility of a definitive trial to determine the effect of LIPUS on functional and clinical outcomes in tibial fractures managed operatively.We conducted a multicenter, concealed, blinded randomized trial of 51 skeletally mature adults with operatively managed tibial fractures who were treated with either LIPUS or a sham device. All participating centers were located in Canada and site investigators were orthopedic surgeons specializing in trauma surgery. The goals of our pilot study were to determine recruitment rates in individual centers, investigators' ability to adhere to study protocol and data collection procedures, our ability to achieve close to 100% follow-up rates, and the degree to which patients were compliant with treatment. Patients were followed for one year and a committee (blinded to allocation) adjudicated all outcomes. The committee adjudicators were experienced (10 or more years in practice) orthopedic surgeons with formal research training, specializing in trauma surgery.Our overall rate of recruitment was approximately 0.8 patients per center per month and site investigators successfully adhered to the study protocol and procedures. Our rate of follow-up at one year was 84%. Patient compliance, measured by an internal timer in the study devices, revealed that 39 (76%) of the patients were fully compliant and 12 (24%) demonstrated a greater than 50% compliance. Based on patient feedback regarding excessive questionnaire burden, we conducted an analysis using data from another tibial fracture trial that revealed the Short Musculoskeletal Function Assessment (SMFA) dysfunction index offered no important advantages over the SF-36 Physical Component Summary (PCS) score. No device-related adverse events were reported.Our pilot study identified key issues that might have rendered a definitive trial unfeasible. By modifying our protocol to address these challenges we have enhanced the feasibility of a definitive trial to explore the effect of LIPUS on tibial fracture healing.The TRUST definitive trial was registered at ClinicalTrials.gov on 21 April 2008 (identifier: NCT00667849).

SUBMITTER: Busse JW

PROVIDER: S-EPMC4060850 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

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Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study.

Busse Jason W JW Bhandari Mohit M Einhorn Thomas A TA Heckman James D JD Leung Kwok-Sui KS Schemitsch Emil E Tornetta Paul P Walter Stephen D SD Guyatt Gordon H GH

Trials 20140604

<h4>Background</h4>The role of low-intensity pulsed ultrasound (LIPUS) in the management of fractures remains controversial. The purpose of this study was to assess the feasibility of a definitive trial to determine the effect of LIPUS on functional and clinical outcomes in tibial fractures managed operatively.<h4>Methods</h4>We conducted a multicenter, concealed, blinded randomized trial of 51 skeletally mature adults with operatively managed tibial fractures who were treated with either LIPUS ...[more]

PMID: 24898987

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Project description:OBJECTIVE: To determine whether low intensity pulsed ultrasound (LIPUS), compared with sham treatment, accelerates functional recovery and radiographic healing in patients with operatively managed tibial fractures. DESIGN: A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 501 patients, enrolled between October 2008 and September 2012, and followed for one year. SETTING: 43 North American academic trauma centers. PARTICIPANTS: Skeletally mature men or women with an open or closed tibial fracture amenable to intramedullary nail fixation. Exclusions comprised pilon fractures, tibial shaft fractures that extended into the joint and required reduction, pathological fractures, bilateral tibial fractures, segmental fractures, spiral fractures >7.5 cm in length, concomitant injuries that were likely to impair function for at least as long as the patient's tibial fracture, and tibial fractures that showed <25% cortical contact and >1 cm gap after surgical fixation. 3105 consecutive patients who underwent intramedullary nailing for tibial fracture were assessed, 599 were eligible and 501 provided informed consent and were enrolled. INTERVENTIONS: Patients were allocated centrally to self administer daily LIPUS (n=250) or use a sham device (n=251) until their tibial fracture showed radiographic healing or until one year after intramedullary fixation. MAIN OUTCOME MEASURES: Primary registry specified outcome was time to radiographic healing within one year of fixation; secondary outcome was rate of non-union. Additional protocol specified outcomes included short form-36 (SF-36) physical component summary (PCS) scores, return to work, return to household activities, return to ?80% of function before injury, return to leisure activities, time to full weight bearing, scores on the health utilities index (mark 3), and adverse events related to the device. RESULTS: SF-36 PCS data were acquired from 481/501 (96%) patients, for whom we had 2303/2886 (80%) observations, and radiographic healing data were acquired from 482/501 (96%) patients, of whom 82 were censored. Results showed no impact on SF-36 PCS scores between LIPUS and control groups (mean difference 0.55, 95% confidence interval -0.75 to 1.84; P=0.41) or for the interaction between time and treatment (P=0.30); minimal important difference is 3-5 points) or in other functional measures. There was also no difference in time to radiographic healing (hazard ratio 1.07, 95% confidence interval 0.86 to 1.34; P=0.55). There were no differences in safety outcomes between treatment groups. Patient compliance was moderate; 73% of patients administered ?50% of all recommended treatments. CONCLUSIONS: Postoperative use of LIPUS after tibial fracture fixation does not accelerate radiographic healing and fails to improve functional recovery.Study registration ClinicalTrialGov Identifier: NCT00667849.

Project description:There remains a compelling biological rationale for both reamed and unreamed intramedullary nailing for the treatment of tibial shaft fractures. Previous small trials have left the evidence for either approach inconclusive. We compared reamed and unreamed intramedullary nailing with regard to the rates of reoperations and complications in patients with tibial shaft fractures.We conducted a multicenter, blinded randomized trial of 1319 adults in whom a tibial shaft fracture was treated with either reamed or unreamed intramedullary nailing. Perioperative care was standardized, and reoperations for nonunion before six months were disallowed. The primary composite outcome measured at twelve months postoperatively included bone-grafting, implant exchange, and dynamization in patients with a fracture gap of <1 cm. Infection and fasciotomy were considered as part of the composite outcome, irrespective of the postoperative gap.One thousand two hundred and twenty-six participants (93%) completed one year of follow-up. Of these, 622 patients were randomized to reamed nailing and 604 patients were randomized to unreamed nailing. Among all patients, fifty-seven (4.6%) required implant exchange or bone-grafting because of nonunion. Among all patients, 105 in the reamed nailing group and 114 in the unreamed nailing group experienced a primary outcome event (relative risk, 0.90; 95% confidence interval, 0.71 to 1.15). In patients with closed fractures, forty-five (11%) of 416 in the reamed nailing group and sixty-eight (17%) of 410 in the unreamed nailing group experienced a primary event (relative risk, 0.67; 95% confidence interval, 0.47 to 0.96; p = 0.03). This difference was largely due to differences in dynamization. In patients with open fractures, sixty of 206 in the reamed nailing group and forty-six of 194 in the unreamed nailing group experienced a primary event (relative risk, 1.27; 95% confidence interval, 0.91 to 1.78; p = 0.16).The present study demonstrates a possible benefit for reamed intramedullary nailing in patients with closed fractures. We found no difference between approaches in patients with open fractures. Delaying reoperation for nonunion for at least six months may substantially decrease the need for reoperation.

Project description:BackgroundRandomized controlled trials (RCT) are regarded as the gold standard for effect evaluation in clinical interventions. However, RCTs may not produce relevant results to all patient groups. We aimed to assess the external validity of a multicenter RCT (DelPhi trial).MethodsThe DelPhi RCT investigated whether elderly patients with displaced proximal humeral fractures (PHFs) receiving reversed total shoulder prosthetic replacement (RTSA) gained better functional outcomes compared to open reduction and internal fixation (ORIF) using an proximal humerus locking plate (PHILOS). Eligible patients were between 65 and 85 years old with severely displaced 11-B2 or 11-C2 fractures (AO/OTA-classification, 2007). We compared baseline and follow-up data of patients for two of the seven hospitals that were included in the DelPhi trial (n = 54) with non-included patients (n = 69). Comparisons were made based on reviewing medical records regarding demographic, health and fracture parameters.ResultsForty-four percent of the eligible patients were included in the DelPhi trial. Comparing included and non-included patients indicated higher incidences of serious heart disease (P = 0.044) and a tendency toward higher tobacco intake (P = 0.067) in non-included patients. Furthermore, non-included patients were older (P = 0.040) and had higher ASA classification (P < 0.001) and were in more need for resident aid (in-home assistance) (P = 0.022) than included patients. The cause of PHF was more frequently related to fall indoors in non-included vs. included patients (P = 0.018) and non-included patients were more prone to other concomitant fractures (P = 0.004). Having concomitant fractures was associated with osteoporosis (P = 0.014). We observed no significant differences in rates of complications or deaths between included and non-included patients within 3 months after treatment. In descending order, non-included patients were treated conservatively, with PHILOS, RTSA, anatomic hemi-prothesis or an alternative type of ORIF. RTSA was the preferred treatment choice for C2-type fractures (P < 0.001).ConclusionsResults from the DelPhi RCT may not directly apply to older PHFs patients with lower health status or concomitant fractures.Level of evidenceLevel 4.

Project description:BackgroundSurgeons agree on the benefits of operative treatment of tibial fractures - the most common of long bone fractures - with an intramedullary rod or nail. Rates of re-operation remain high - between 23% and 60% in prior trials - and the two alternative nailing approaches, reamed or non-reamed, each have a compelling biological rationale and strong proponents, resulting in ongoing controversy regarding which is better.Methods/designThe objective of this trial was to assess the impact of reamed versus non-reamed intramedullary nailing on rates of re-operation in patients with open and closed fractures of the tibial shaft. The study to prospectively evaluate reamed intramedullary nails in tibial fractures (S.P.R.I.N.T) was a multi-center, randomized trial including 29 clinical sites in Canada, the United States and the Netherlands which enrolled 1200 skeletally mature patients with open (Gustilo Types I-IIIB) or closed (Tscherne Types 0-3) fractures of the tibial shaft amenable to surgical treatment with an intramedullary nail. Patients received a statically locked intramedullary nail with either reamed or non-reamed insertion. The first strategy involved fixation of the fracture with an intramedullary nail following reaming to enlarge the intramedullary canal (Reamed Group). The second treatment strategy involved fixation of the fracture with an intramedullary nail without prior reaming of the intramedullary canal (Non-Reamed Group). Patients, outcome assessors, and data analysts were blinded to treatment allocation. Peri-operative care was standardized, and re-operations before 6 months were proscribed. Patients were followed at discharge, 2 weeks post-discharge, and at 6 weeks, 3, 6, 9, and 12 months post surgery. A committee, blinded to allocation, adjudicated all outcomes.DiscussionThe primary outcome was re-operation to promote healing, treat infection, or preserve the limb (fasciotomy for compartment syndrome after nailing). The primary outcome was a composite comprising the following re-operations: bone grafts, implant exchanges, and dynamizations, in patients with fracture gaps less than 1 cm post intramedullary nail insertion. Infections and fasciotomies were considered events irrespective of the fracture gap. We planned a priori to conduct a subgroup analysis of outcomes in patients with open and closed fractures. S.P.R.I.N.T is the largest collaborative trial evaluating alternative orthopaedic surgical interventions in patients with tibial shaft fractures. The methodological rigor will set new benchmarks for future trials in the field and its results will have important impact on patient care. The S.P.R.I.N.T trial was registered [ID NCT00038129] and received research ethics approval (REB#99-077).

Project description:BACKGROUND AND OBJECTIVES:Canadian home hemodialysis guidelines highlight the potential differences in complications associated with arteriovenous fistula (AVF) cannulation technique as a research priority. Our primary objective was to determine the feasibility of randomizing patients with ESKD training for home hemodialysis to buttonhole versus stepladder cannulation of the AVF. Secondary objectives included training time, pain with needling, complications, and cost by cannulation technique. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:All patients training for home hemodialysis at seven Canadian hospitals were assessed for eligibility, and demographic information and access type was collected on everyone. Patients who consented to participate were randomized to buttonhole or stepladder cannulation technique. Time to train for home hemodialysis, pain scores on cannulation, and complications over 12 months was recorded. For eligible but not randomized patients, reasons for not participating in the trial were documented. RESULTS:Patient recruitment was November 2013 to November 2015. During this time, 158 patients began training for home hemodialysis, and 108 were ineligible for the trial. Diabetes mellitus as a cause of ESKD (31% versus 12%) and central venous catheter use (74% versus 6%) were more common in ineligible patients. Of the 50 eligible patients, 14 patients from four out of seven sites consented to participate in the study (28%). The most common reason for declining to participate was a strong preference for a particular cannulation technique (33%). Patients randomized to buttonhole versus stepladder cannulation required a shorter time to complete home hemodialysis training. We did not observe a reduction in cannulation pain or complications with the buttonhole method. Data linkages for a formal cost analysis were not conducted. CONCLUSIONS:We were unable to demonstrate the feasibility of conducting a randomized, controlled trial of buttonhole versus stepladder cannulation in Canada with a sufficient number of patients on home hemodialysis to be able to draw meaningful conclusions.

Project description:BackgroundOpen tibial fractures are common injuries in low and middle-income countries, but there is no consensus regarding treatment with intramedullary nailing versus external fixation. The purpose of the present study was to compare the outcomes of initial treatment with intramedullary nailing or external fixation in adults with open tibial fractures.MethodsWe conducted a randomized clinical trial (RCT) at a tertiary orthopaedic center in Tanzania. Adults with acute diaphyseal open tibial fractures were randomly assigned to statically locked, hand-reamed intramedullary nailing or uniplanar external fixation. The primary outcome was death or reoperation for the treatment of deep infection, nonunion, or malalignment. Secondary outcomes included quality of life as measured with the EuroQol-5 Dimensions (EQ-5D) questionnaire, radiographic alignment, and healing as measured with the modified Radiographic Union Scale for Tibial fractures (mRUST).ResultsOf the 240 patients who were enrolled, 221 (92.1%) (including 111 managed with intramedullary nailing and 110 managed with external fixation) completed 1-year follow-up. There were 44 primary outcome events (with rates of 18.0% and 21.9% in the intramedullary nailing and external fixation groups, respectively) (relative risk [RR] = 0.83 [95% confidence interval (CI), 0.49 to 1.41]; p = 0.505). There was no significant difference between the groups in terms of the rate of deep infection. Intramedullary nailing was associated with a lower risk of coronal malalignment (RR = 0.11 [95% CI, 0.01 to 0.85]; p = 0.01) and sagittal malalignment (RR = 0.17 [95% CI, 0.02 to 1.35]; p = 0.065) at 1 year. The EQ-5D index favored intramedullary nailing at 6 weeks (mean difference [MD] = 0.07 [95% CI = 0.03 to 0.11]; p < 0.001), but this difference dissipated by 1 year. Radiographic healing (mRUST) favored intramedullary nailing at 6 weeks (MD = 1.2 [95% CI = 0.4 to 2.0]; p = 0.005), 12 weeks (MD = 1.0 [95% CI = 0.3 to 1.7]; p = 0.005), and 1 year (MD = 0.8 [95% CI = 0.2 to 1.5]; p = 0.013).ConclusionsTo our knowledge, the present study is the first RCT assessing intramedullary nailing versus external fixation for the treatment of open tibial fractures in sub-Saharan Africa. Differences in primary events were not detected, and only coronal alignment significantly favored the use of intramedullary nailing.Level of evidenceTherapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

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Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study.

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Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study.

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