Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial.

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.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: The TRUST definitive trial was registered at ClinicalTrials.gov on 21 April 2008 (identifier: NCT00667849).

The fate of manuscripts rejected by The Journal of Bone and Joint Surgery (American Volume).

BACKGROUND: Of the many manuscripts that are submitted to The Journal of Bone and Joint Surgery (American Volume) (JBJS-A) for publication, the majority are not accepted. However, little is known about the outcome of these rejected submissions. To determine the fate of studies rejected by JBJS-A, we conducted a follow-up investigation of all clinical and basic science manuscripts that were submitted to The Journal between January 2004 and June 2005 but were not accepted. METHODS: For each rejected manuscript, data were extracted on a wide variety of scientific and nonscientific characteristics, which were plausibly related to subsequent publication. PubMed searches were conducted to determine which manuscripts achieved full publication within five years, and logistic regression was used to identify the factors associated with publication. To further elucidate the factors associated with publication, a survey was administered to the corresponding author of each rejected manuscript. RESULTS: At five years following rejection by JBJS-A, 75.8% (696 of 918) of manuscripts had reached full publication. In the multivariate analysis, factors associated with a higher likelihood of subsequent publication included grade of initial review by JBJS-A (p = 0.029), disclosure of a for-profit or nonprofit conflict of interest (p = 0.028 and 0.027, respectively), and a greater number of prior publications in frequently cited orthopaedic journals by the corresponding author (p < 0.0001). Manuscripts were less likely to reach full publication if the corresponding author was from Asia or the Middle East (p = 0.004) or was a woman (p = 0.003). Among survey respondents who indicated that their study had not yet reached full publication, the most commonly cited reason was lack of time (reported by 51.4% of respondents [thirty-eight of seventy-four]). CONCLUSIONS: Most manuscripts (75.8%) not accepted by JBJS-A were published elsewhere within five years of rejection. The factors predictive of subsequent publication were primarily investigator-related as opposed to study-related. Given this low threshold for eventual publication, readers are encouraged to use criteria other than inclusion in the PubMed database to identify high-quality papers.

Nonoperative treatment of an os peroneum fracture in a high-level athlete: a case report.

BACKGROUND: The os peroneum is a sesamoid bone in the peroneus longus tendon. Fractures of the os peroneum are rare. Some authors recommend surgery for active patients. CASE DESCRIPTION: A 41-year-old male professional tennis coach sustained a minimally displaced fracture of the os peroneum. He was treated with restricted weightbearing for 2 weeks, followed by physical therapy and gradual return to activities. He returned to tennis 8 weeks after injury. Followup 7 years after the injury showed he had full strength, full motion, and a radiographically healed os peroneum. The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale score was 100 and Ankle Activity Score and Tegner Activity Level Scale were unchanged from those before injury. LITERATURE REVIEW: Fracture of the os peroneum is a rare injury and treatment recommendations are based largely on very small series and case reports. Proposed treatment strategies for fracture of the os peroneum include nonoperative treatment, fixation of the fracture, excision of the bone with direct repair of the tendon, and tenodesis of the peroneus longus to the peroneus brevis. PURPOSES AND CLINICAL RELEVANCE: Although some surgeons suggest fracture of the os peroneum should be treated operatively in active patients, this case shows nonoperative treatment allowed pain-free return to activities in a high-level athlete with a minimally-displaced fracture.

Testing for the presence of positive-outcome bias in peer review: a randomized controlled trial.

BACKGROUND: If positive-outcome bias exists, it threatens the integrity of evidence-based medicine. METHODS: We sought to determine whether positive-outcome bias is present during peer review by testing whether peer reviewers would (1) recommend publication of a "positive" version of a fabricated manuscript over an otherwise identical "no-difference" version, (2) identify more purposefully placed errors in the no-difference version, and (3) rate the "Methods" section in the positive version more highly than the identical "Methods" section in the no-difference version. Two versions of a well-designed randomized controlled trial that differed only in the direction of the finding of the principal study end point were submitted for peer review to 2 journals in 2008-2009. Of 238 reviewers for The Journal of Bone and Joint Surgery and Clinical Orthopaedics and Related Research randomly allocated to review either a positive or a no-difference version of the manuscript, 210 returned reviews. RESULTS: Reviewers were more likely to recommend the positive version of the test manuscript for publication than the no-difference version (97.3% vs 80.0%, P < .001). Reviewers detected more errors in the no-difference version than in the positive version (0.85 vs 0.41, P < .001). Reviewers awarded higher methods scores to the positive manuscript than to the no-difference manuscript (8.24 vs 7.53, P = .005), although the "Methods" sections in the 2 versions were identical. CONCLUSIONS: Positive-outcome bias was present during peer review. A fabricated manuscript with a positive outcome was more likely to be recommended for publication than was an otherwise identical no-difference manuscript.