Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials

An amendment to this paper has been published and can be accessed via the original article

The Effects of Locking Inserts and Overtorque on the Mechanical Properties of a Large Fragment Locking Compression Plate

PURPOSE: The study was to determine the effect of locking hole inserts and their insertion torque on the fatigue life of a large fragment Locking Compression Plate (LCP) under bending forces. METHODS: Fatigue strength of the LCP was examined using cyclic three-point bend testing at 80% yield strength of the construct. Locking hole inserts were used in 2, 4, and 6-hole of a 12-hole plate to simulate three different working lengths. Within each working length, plates were tested without locking inserts serving as the control group. In the experimental groups, inserts were tightened to manufacturer recommendations (4 Nm) and using overtorque (8 Nm). RESULTS: Significantly fewer cycles to failure were observed in control groups versus the locking hole insert groups for all working lengths (2-hole: 4 Nm p = 0.003, 8 Nm p = 0.003; 4-hole: 4 Nm p = 0.02, 8 Nm p \u3c 0.001; 6-hole: 4 Nm p = 0.004, 8 Nm p \u3c 0.001). There was a statistically significant increase in fatigue strength when using overtorque in the 4-hole (p = 0.04) and 6-hole (p = 0.01) defect groups. This was not shown in the 2-hole defect group (p = 0.99). CONCLUSIONS: By placing locking inserts in the empty locking regions of Combi holes along the working length, the number of cycles to failure was increased. Tightening inserts to twice the recommended insertion torque further increased cycles to failure in longer working length models. A longer fatigue life has the potential to decease the incidence of plate failure especially in the setting of delayed union due to poor intrinsic healing capacity, fractures in the geriatric population, osteoporosis and periprosthetic fractures

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

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