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

Factors Associated with Revision Surgery after Internal Fixation of Hip Fractures

Background: Femoral neck fractures are associated with high rates of revision surgery after management with internal fixation. Using data from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial evaluating methods of internal fixation in patients with femoral neck fractures, we investigated associations between baseline and surgical factors and the need for revision surgery to promote healing, relieve pain, treat infection or improve function over 24 months postsurgery. Additionally, we investigated factors associated with (1) hardware removal and (2) implant exchange from cancellous screws (CS) or sliding hip screw (SHS) to total hip arthroplasty, hemiarthroplasty, or another internal fixation device. Methods: We identified 15 potential factors a priori that may be associated with revision surgery, 7 with hardware removal, and 14 with implant exchange. We used multivariable Cox proportional hazards analyses in our investigation. Results: Factors associated with increased risk of revision surgery included: female sex, [hazard ratio (HR) 1.79, 95% confidence interval (CI) 1.25-2.50; P = 0.001], higher body mass index (fo

Immediate Unprotected Weightbearing After Open Reduction Internal Fixation of Ankle Fractures: A Prospective Trial

Category: Trauma; Ankle Introduction/Purpose: Ankle fractures are among the most common orthopaedic injuries treated surgically, with indications well- established. However, post-operative care protocols remain controversial and vary widely between surgeons. This prospective controlled trial compared functional outcomes of the local institutional standard (control group) of nonweightbearing (NWB) for two weeks in a short leg splint followed by weightbearing as-tolerated (WBAT) in a boot with range of motion (ROM), versus immediate unprotected weightbearing (IMWB). Methods: 40 consecutive patients undergoing ankle fracture open reduction internal fixation (ORIF) at a single level-1 trauma center meeting inclusion and exclusion criteria were enrolled into the control group, and the next 40 consecutive patients were enrolled in the IMWB group. The study sample size was powered to detect a statistically significant difference in the Olerud- Molander score (OMAS), the primary study outcome. Secondary outcome measures included the Euroquol-5D (EQ5D) self reported patient score and Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) scores, ankle ROM, wound complications, time to return to work, radiograph measurements and loss of fracture reduction. Patients underwent ankle ORIF with surgical technique and implant choice left to the surgeon’s discretion. Postoperative follow-ups were done at 2, 6, and 12 weeks. Results: Demographics of the two groups were similar except for the control group having 4 patients with type II diabetes and the IMWB group having none. There was no statistically significant difference in OMAS at any time point. There were also no statistically significant differences in the EQ5D or WPAI:SHP scores, ROM, time to return to work, or radiographic measurements at any time point. The IMWB group had 5 superficial wound complications versus 1 in the control group. There were 2 cases of loss of reduction in the IMWB group versus none in the control group. Both loss of reductions were determined to not be related to the post operative protocol. Conclusion: Immediate unprotected weightbearing after ORIF of ankle fractures results in equivocal functional outcomes compared with 2 weeks of NWB followed by protected weightbearing and ROM over the first 3 postoperative months. An increased number of wound healing complications was seen in the IMWB group which requires further investigation

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

Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial

Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. Findings Between Mar