Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol.

Importance: The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair. Objective: To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair. Design, Setting, and Participants: The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders. Discussion: The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice. Trial Registration: ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962.

A Survey for End-Stage Ankle Arthritis Treatment: Ankle Arthrodesis Versus Ankle Arthroplasty.

With promising technological advances, ankle arthroplasty has become an alternative to arthrodesis, traditionally the gold standard, for treating end-stage ankle arthritis. We collected knowledge and perceptions on both procedures to determine the need for a patient decision aid for these patients by administering a cross-sectional survey to 103 orthopaedic surgeons. Respondents were predominantly male and 41 to 50 years old. Half of those who stated that they do not perform arthroplasty said this was because they do not have adequate training. Additionally, certain variables were associated with the surgeon's choice of intervention: patient gender, age, body mass index, postoperative activity level, employment type, perceived risk of infection, neurovascular injury or wound complication, risk of developing or pre-existing adjacent arthritis, deformity, malalignment, bone loss or abnormal bone quality, number of prior ankle operations, cause of arthritis, and desire for motion preservation. The majority agreed that they always incorporate patient preferences into their decisions and that a decision aid would be beneficial. This survey revealed that several patient characteristics are influential in the surgeon's preference for either arthroplasty or arthrodesis for end-stage ankle arthritis. Because the majority of surgeons incorporate patient preferences in their decisions and report that a decision aid would be beneficial for informed decision-making in this clinical scenario, this survey identified an unmet need supporting the development of such a tool for these patients.

Posterior-Based Approaches to Open Reduction Internal Fixation of Bimalleolar and Trimalleolar Fractures: A Systematic Review and Meta-analysis.

Although there is growing evidence supporting posterior-based surgical approaches to open reduction internal fixation (ORIF) of malleolar fractures, the lateral approach still remains the standard of care for this injury. The purpose of this review was to integrate the results of several studies investigating outcomes following posterior-based approaches to the ORIF of malleolar fractures. The literature search was undertaken using PubMed, the Cochrane Library, and Embase. Crude event rates for fracture healing and postoperative complications were calculated. When possible, meta-analyses were conducted to estimate the relative risk of these outcomes between patients treated by posterior-based approaches versus other approaches to ORIF of malleolar fractures. Twenty-two studies were eligible, and 4 studies were included in the meta-analyses. The healing rate was 100% in all patients, regardless of the surgical approach. Overall, 1.26% of patients developed an infection, 0.63% required reoperation, 1.13% experienced aseptic loosening, 5.53% experienced pain after treatment, and 2.52% experienced symptomatic hardware. No malunion or heterotopic ossification was reported in any study. Among patients treated with a posterior-based approach, the most frequently reported complication was infection (2.50%), with lower rates of reoperation and postoperative pain. Patients with trimalleolar fractures experienced slightly poorer outcomes. Patients treated by posterior-based approaches had a significantly increased risk of infection (p = .010) relative to those treated by the lateral approach; patients treated by the lateral approach had a significantly increased risk of pain after surgery (p = .004) and symptomatic hardware (p = .007). This study brought together evidence that posterior-based surgical approaches and non-posterior-based approaches to ORIF are effective in healing malleolar fractures, with significant differences in specific postoperative complications that need to be further explored.

Intra-articular Injections in the Treatment of Symptoms from Ankle Arthritis: A Systematic Review.

BACKGROUND: Intra-articular (IA) injections are commonly used to treat knee arthritis pain; however, whether their efficacy generalizes to ankle arthritis remains debatable. We aimed to evaluate the evidence for IA therapies in the management of this patient population. METHODS: We performed a literature search for observational and randomized controlled trials (RCTs). Treatments included corticosteroids (CS), hyaluronic acid (HA), platelet-rich plasma (PRP), and mesenchymal stem cells (MSC). We extracted study details, patient demographics, treatment characteristics, efficacy outcomes, and safety. When feasible, data from RCTs were meta-analyzed using a random-effects model and 95% confidence intervals (CIs) were calculated. A P value <.05 was considered statistically significant. RESULTS: We identified 27 studies (1085 patients). Ankle OA, rheumatoid arthritis (RA), and hemophilic arthropathy populations were examined. The majority of studies were observational (20 studies); the only RCTs were those evaluating HA. Case series demonstrated favorable results in terms of symptomatic relief with CS, HA, PRP, and MSC injections; however, the effects of CS may only be short term and the evidence on MSCs was limited to 1 study with 6 ankle OA patients. Pooled results (3 RCTs, 109 patients) suggested significantly improved Ankle Osteoarthritis Scale scores with HA over saline at 6 months, with a mean difference of 12.47 points (95% CI 1.18-23.77, P = .03). CONCLUSION: Evidence from small trials favors HA and PRP injections for the treatment of pain associated with ankle osteoarthritis. However, the relative efficacy of all injectable therapies is far from definitive and warrants further high-quality comparative trials. LEVEL OF EVIDENCE: Level III, systematic review.

Electrical stimulation for fracture healing: current evidence.

This article provides an overview of the biology behind the use of electrical stimulation in fracture healing and discusses the current methods of electrical bone growth stimulation. In addition, we review the best available clinical evidence for the use of electrical stimulation in the treatment of delayed and nonunions of fractures. Our search identified 4 meta-analyses on the use of electrical stimulation on fracture healing. The most methodologically rigorous and recent meta-analysis suggests that the current evidence is insufficient to conclude a benefit of electromagnetic stimulation in improving the rate of union in patients with a fresh fracture, osteotomy, delayed union, or nonunion. The other 3 meta-analyses that we identified suggested a more significant treatment effect from electrical stimulation. Although the evidence supporting electrical stimulation does trend in favor of its use to help achieve bony union, further large, multicenter, randomized, controlled trials are required to resolve the current uncertainty surrounding the use of electrical stimulation and fracture healing.

Making decisions about prognosis in evidence-based practice.

Prognostic studies are designed to investigate factors that impact the outcome of a disease or its treatment. These factors include, but are not limited to, inherent patient characteristics, the state of the disease, and severity of symptoms. The results of prognostic studies can be used to guide the treatment of patients with similar conditions and overall characteristics. It is the purpose of this paper to provide an outline of how to perform an unbiased appraisal of a prognostic study, allowing the physician to assess the applicability of the results to their patient and thereby assist with decision making in clinical practice.