Patients with tibial pilon fractures have a higher incidence of post-traumatic osteoarthritis than those with fractures of the tibial plateau. This may indicate that pilon fractures present a greater mechanical insult to the joint than do plateau fractures. We tested the hypothesis that fracture energy and articular fracture edge length, two independent indicators of severity, are higher in pilon than plateau fractures. We also evaluated whether clinical fracture classification systems accurately reflect severity. Seventy-five tibial plateau fractures and 52 tibial pilon fractures from a multi-institutional study were selected to span the spectrum of severity. Fracture severity measures were calculated using objective CT-based image analysis methods. The ranges of fracture energies measured for tibial plateau and pilon fractures were 3.2-33.2 Joules (J) and 3.6-32.2 J, respectively, and articular fracture edge lengths were 68.0-493.0 mm and 56.1-288.6 mm, respectively. There were no differences in the fracture energies between the two fracture types, but plateau fractures had greater articular fracture edge lengths (p < 0.001). The clinical fracture classifications generally reflected severity, but there was substantial overlap of fracture severity measures between different classes. Similar fracture energies with different degrees of articular surface involvement suggest a possible explanation for dissimilar rates of post-traumatic osteoarthritis for fractures of the tibial plateau compared to the tibial pilon. The substantial overlap of severity measures between different fracture classes may well have confounded prior clinical studies relying on fracture classification as a surrogate for severity. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:618-624, 2017.

Collaborations between orthopaedic training programs in developed countries and international sites in austere environments offer abundant benefits and mutual enrichment. It is often assumed that the exchange is one-sided and we hope to dispel that assumption. Despite the logistical challenges inherent in these partnerships, our experience has been unanimously reviewed as "greatly beneficial" to visiting residents/faculty and surgeons/trainees at the host location. We hope that this article will (1) encourage faculty at training programs to permit and enable residents to experience international orthopaedics while still in training; (2) encourage faculty to visit international hospitals while contributing expertise in subspecialty surgery, research, and teaching; and (3) encourage international hospitals to create opportunities for clinical and research collaboration with academic orthopaedics departments.

Objectives

Determine the agreement between subjective assessments of fracture severity and an objective computed tomography (CT)-based metric of fracture energy in tibial plateau fractures.

Methods

Six fellowship-trained orthopaedic trauma surgeons independently rank-ordered 20 tibial plateau fractures in terms of severity based on anteroposterior and lateral knee radiographs. A CT-based image analysis methodology was used to quantify the fracture energy, and agreement between the surgeons' severity rankings and the fracture energy metric was tested by computing their concordance, a statistical measure that estimates the probability that any 2 cases would be ranked with the same ordering by 2 different raters or methods.

Results

Concordance between the 6 orthopaedic surgeons ranged from 82% to 93%, and concordance between surgeon severity rankings and the computed fracture energy ranged from 73% to 78%.

Conclusions

There is a high level of agreement between experienced surgeons in their assessments of tibial plateau fracture severity, and a slightly lower agreement between the surgeon assessments and an objective CT-based metric of fracture energy. Taken together, these results suggest that experienced surgeons share a similar understanding of what makes a tibial plateau fracture more or less severe, and an objective CT-based metric of fracture energy captures much but not all of that information. Further research is ongoing to characterize the relationship between surgeon assessments of severity, fracture energy, and the eventual clinical outcomes for patients with fractures of the tibial plateau.

Level of evidence

Prognostic Level II.

Introduction

Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent.

Methods

The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have.

Results

Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation.

Discussion

Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

Introduction

Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.

Methods

Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.

Results

7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p < 0.001).

Conclusions

Implementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.