The impact of COVID-19 restrictions on participant enrollment in the PREPARE trial.

Background: At the initiation of the COVID-19 pandemic, restrictions forced researchers to decide whether to continue their ongoing clinical trials. The PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities) trial is a pragmatic cluster-randomized crossover trial in patients with open and closed fractures. PREPARE was enrolling over 200 participants per month at the initiation of the pandemic. We aim to describe how the COVID-19 research restrictions affected participant enrollment. Methods: The PREPARE protocol permitted telephone consent, however, sites were obtaining consent in-person. To continue enrollment after the initiation of the restrictions participating sites obtained ethics approval for telephone consent scripts and the waiver of a signature on the consent form. We recorded the number of sites that switched to telephone consent, paused enrollment, and the length of the pause. We used t-tests to compare the differences in monthly enrollment between July 2019 and November 2020. Results: All 19 sites quickly implement telephone consent. Fourteen out of nineteen (73.6%) sites paused enrollment due to COVID-19 restrictions. The median length of enrollment pause was 46.5 days (range, 7-121 days; interquartile range, 61 days). The months immediately following the implementation of restrictions had significantly lower enrollment. Conclusion: A pragmatic design allowed sites to quickly adapt their procedures for obtaining informed consent via telephone and allowed for minimal interruptions to enrollment during the pandemic.

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.

Percutaneous Plate Osteosynthesis of Ulnar Shaft Fractures: A Surgical Technique and Case Series.

Treatment of ulnar diaphyseal fractures can range broadly from nonoperative with immobilization to surgical intervention with a variety of implants or approaches. At a Level 1 trauma center, a series of ulnar shaft fractures have been treated using a percutaneous plating technique that is base beneath the extensor carpi ulnaris. This technique description illustrates relevant anatomy, important patient and injury characteristics, implant considerations, and potential outcomes and complications. The described treatment option provides an effective way of spanning comminuted fracture patterns without disrupting the surrounding biology while providing stable fixation. An associated patient series is included which enumerates associated injuries and describes limited follow-up. In the multiply injured trauma patient, such a fixation method also had potential benefits for their overall care and rehabilitation.

A technique for low-profile intramedullary fixation of intraarticular proximal ulnar fractures.

A technique for low-profile fixation of intraarticular proximal ulnar fractures using an intramedullary (IM) screw is described. A retrospective study of the early outcome of patients treated with this technique versus patients treated with 3.5-mm LCDP plating is also presented. The authors report on 33 patients managed with IM fixation and 16 managed with plate fixation. Mean follow-up time was 16 months. Injuries managed with IM fixation had decreased flexion contractures and improved pronation (p<.05) compared with injuries treated with plating. Elbow arc of motion and supination did not differ significantly. Hardware removal was required in 56% of injuries treated with plating and in 9% of injuries treated with IM fixation. Release for limited motion was required in about 25% of patients in both groups. Mayo scores did not differ between both groups. Low-profile intramedullary fixation facilitates wound closure and soft tissue management and results in similar short-term outcomes as plating. The authors recommend this technique for cases with significant soft tissue injury where plating may result in a difficult closure or prominent hardware.

Clinical results of olecranon fractures treated with multiplanar locked intramedullary nailing.

BACKGROUND: Proximal ulnar fractures have traditionally been fixed with either tension band wiring or plate and screw fixation. These traditional techniques often irritate the surrounding soft tissues, potentially leading to subsequent secondary hardware removal surgeries. Intramedullary proximal ulnar fixation provides similar rigid fixation, however, no review yet exists to support the clinical use of currently available implants. OBJECTIVES: To investigate the clinical and radiographic short-term outcomes for multiplanar locked intramedullary nails used to treat proximal ulnar fractures. METHODS: A retrospective multicenter review was conducted in 28 patients with unstable olecranon fractures treated with a new multiplanar locked intramedullary nailing system (OlecraNail, Mylad Orthopedic Solutions, McLean, VA). Radiographic union was estimated, and serial clinical outcome up to one year was assessed by strength, motion, pain (visual analog scale), and a subcutaneous ulna border palpation (SCUBP) test to assess hardware prominence. RESULTS: All fractures achieved union by 8 weeks. At 12 weeks postoperatively, all motion was within 10 degrees of the contralateral side in all directions. Of the 18 patients who underwent SCUBP testing, all 18 patients reported to have no pain at 12 weeks. At one-year follow-up, all patients had resumed normal activities, including work and athletics. All of the patients who underwent the SCUBP testing continued to have no pain. CONCLUSIONS: Multiplanar locked intramedullary nails offer effective management for proximal ulna fractures similar to those reported with plating techniques. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.