Aims

The Fluid Lavage in Open Fracture Wounds (FLOW) trial was a multicentre, blinded, randomized controlled trial that used a 2 × 3 factorial design to evaluate the effect of irrigation solution (soap versus normal saline) and irrigation pressure (very low versus low versus high) on health-related quality of life (HRQL) in patients with open fractures. In this study, we used this dataset to ascertain whether these factors affect whether HRQL returns to pre-injury levels at 12-months post-injury.

Purpose: We aimed to preliminarily validate a newly developed system, the radiographic union scale for tibial (RUST) fracture healing. We hypothesized that RUST would demonstrate better inter-rater reliability than assessment of the number of cortices bridged and correlate with functional outcomes at least as strongly as surgeon’s assessment of cortical bridging.

Method: Three blinded orthopaedic trauma surgeons independently assigned a RUST score and a number of cortices bridged by callus (zero to four) to each set of AP and lateral radiographs at each follow up period. RUST is scored from four (definitely not healed) to 12 (definitely healed) based on the presence or absence of callus and of a visible fracture line at the total of four cortices visible.

Results: For 549 sets of reviewed radiographs, inter-rater reliability for RUST scores were found to be substantially higher than for assessment of the number of cortices bridged (intra-class correlation coefficient=0.84; 95% CI, 0.80–0.87 versus kappa = 0.73; 95% CI, 0.64 – 0.81, respectively). Both methods of assessing radiographic healing were strongly correlated with weight-bearing status (r and ρ> 0.50), moderately correlated with patient-reported functional recovery and the SF-36 Physical Functioning component scores (r and ρ> 0.30), and minimally correlated with HUI Mark II scores, return to work, and the SF-36 Role Physical component and Physical Component Summary scores (r and ρ> 0.10). Neither assessment was correlated with patient-reported pain scores. All correlations were similar for RUST and the number of cortices bridged.

Conclusion: This study provides preliminary evidence that RUST can be used as a valid and reliable alternative assessment of tibial fracture healing.

Purpose: Radiographic healing is a common outcome measure in orthopaedic trials and adjudication by outcome assessors is often conducted using only plain radiographs. We explored the effect of adding clinical notes to radiographs in the adjudication process of a pilot trial of tibial shaft fractures.

Method: Radiographic and clinical data from a multicenter clinical trial of 51 patients with operatively treated tibial fractures formed the basis of the study data. An independent adjudication committee of three blinded orthopaedic trauma surgeons evaluated radiographs for time to fracture healing. This committee then evaluated clinical notes associated with each radiographic follow up visit and were asked to either revise or maintain their initial impression. We calculated the proportion of time to healing consensus decisions that changed after evaluation of clinical notes. We further examined the contents of the clinical notes and its relative influence on the committee’s decisions.

Results: Forty-seven of 51 patients were determined to have radiographic evidence of healing during the trial follow-up period, and consideration of the clinical notes resulted in a change of 40% (19 of 47) of time to healing consensus decisions; however, revised decisions were equally likely to support an earlier or a later time to healing.

Conclusion: Addition of clinical notes changed the adjudication committee’s decision of radiographic fracture healing in a substantial number of cases. Our findings suggest that orthopedic trialists should consider the addition of clinical notes to adjudication material in studies of fracture healing.

Purpose: Unbiased outcome assessment in orthopedic clinical trials has the potential to improve trial validity. The approaches used to limit bias in outcome assessment in orthopaedic trials remain unclear. The objective of this systematic review was to assess the reporting and process of outcomes assessment practices in the current orthopaedic trauma literature.

Method: We searched eight high-impact-factor medical and orthopaedic journals manually and using the MED-LINE electronic database for reports of randomized controlled trials published from 2005 to 2008 pertaining to the surgical treatment of trauma-related injuries. Two reviewers independently determined study eligibility and extracted relevant data from included trials.

Results: Of the 7910 citations identified during our search, 47 randomized controlled trials, which included a total of 4706 patients, met our inclusion criteria. Of 47 studies, 39 (83%) provided a statement to describe some process of outcome assessment and 29 (74%) reported using an unblinded individual as the outcome adjudicator. Four studies (10%) reported using a second assessor to verify outcome measurements, and three studies (8%) reported the use of an adjudication committee to reach endpoint decisions via consensus. No included study provided a rationale for the use of their chosen approach to adjudication. The most commonly adjudicated outcomes included fracture healing (15 studies), reoperation rate (6 studies), and general clinical assessment of post-operative complications and limb function (30 studies), mainly by orthopaedic surgeons. Blinding of outcome assessors was not performed or unclear in 38 studies (81%).

Conclusion: Despite the importance of the outcome assessment process in orthopedic trauma trials, key aspects of outcome assessment are insufficiently reported. This limits the ability of readers to assess the validity of published trials.

Purpose: Although blinding of outcome assessors is crucial to minimize bias in clinical trials, the majority of surgical trials do not blind these individuals in part due to practical difficulties inherent in surgical interventions. We devised and tested techniques to blind outcome assessors in trials of femoral neck fracture fixation.

Method: We developed three techniques to mask radiographs of femoral neck fractures fixated with cancellous screws or dynamic hip screws: Blackout, Subtraction, and Overlay. 50 orthopaedic trauma surgeons assessed 32 radiographs blinded with each of these techniques. We considered:

The ability to mask the surgeons (the proportion of radiographs in which the surgeons were able to correctly identify the implant and the Bang Blinding Index);

Results: All three techniques achieved low proportions of correct identification of cancellous or dynamic screws (14.9% for Blackout, 26.9% for Subtraction, 22.1% for Overlay) and high proportions of “don’t know” responses (72.3%, 48.4%, 52.8% respectively). The Bang Blinding Indices were close to 0 (perfect blinding) for all three techniques (−0.024 to 0.008). The interrater reliability of quality of reduction in the blinded images (ICC = 0.55 – 0.57) was similar to the reliability of the unblinded radiographs (ICC = 0.60). Surgeons perceived the Overlay images as much more difficult to rate in 6.9% of radiographs, compared with 9.7% of Subtraction images (p=0.25) and 28.0% of Blackout images (p< 0.001).

Conclusion: Three techniques of blinding radiographs of femoral neck fractures successfully mask surgeons to the type of implant fixated, do not compromise reliability of reduction ratings, and do not make the rating process substantially more difficult. Trialists should explore creative approaches such as these to blind as many individuals as possible when designing trials, and should incorporate rigorous approaches to testing the success of blinding.