Assessing Soft Tissue Perfusion Using Laser-Assisted Angiography in Tibial Plateau and Pilon Fractures: A Pilot Study.

OBJECTIVES: To determine whether skin perfusion surrounding tibial plateau and pilon fractures is associated with the Tscherne classification for severity of soft tissue injury. The secondary aim was to determine if soft tissue perfusion improves from the time of injury to the time of definitive fracture fixation in fractures treated using a staged protocol. DESIGN: Prospective cohort study. SETTING: Academic trauma center. PATIENTS: Eight pilon fracture patients and 19 tibial plateau fracture patients who underwent open reduction internal fixation. MAIN OUTCOME MEASURES: Skin perfusion (fluorescence units) as measured by LA-ICGA. RESULTS: Six patients were classified as Tscherne grade 0, 9 as grade 1, 10 as grade 2, and 2 as grade 3. Perfusion decreased by 14 fluorescence units (95% confidence interval, -21 to -6; P < 0.01) with each increase in Tscherne grade. Sixteen patients underwent staged fixation with an external fixator (mean time to definitive fixation 14.1 days). The mean perfusion increased significantly at the time of definitive fixation by a mean of 13.9 fluorescence units (95% confidence interval 4.8-22.9; P = 0.01). CONCLUSIONS: LA-ICGA perfusion measures are associated with severity of soft tissue injury surrounding orthopaedic trauma fractures and appear to improve over time when fractures are stabilized in an external fixator. Further research is warranted to investigate whether objective perfusion measures are predictive of postoperative wound healing complications and whether this tool can be used to effectively guide timing of safe surgical fixation. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

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.

A Prospective Clinical Trial Comparing Surgical Fixation Versus Nonoperative Management of Minimally Displaced Complete Lateral Compression Pelvis Fractures.

OBJECTIVE: To compare the early pain and functional outcomes of operative fixation versus nonoperative management for minimally displaced complete lateral compression (LC; OTA/AO 61-B1/B2) pelvic fractures. DESIGN: Prospective clinical trial. SETTING: Two academic trauma centers. PATIENTS: Forty-eight adult patients with LC pelvic ring injuries with <10 mm of displacement were treated nonoperatively and 47 with surgical fixation. Sixty percent of participants were randomized. Seventy-three percent of the fractures were displaced <5 mm, and 71% were LC-1 patterns. INTERVENTION: Operative fixation versus nonoperative management. MAIN OUTCOME MEASUREMENTS: The primary outcome was patient-reported pain using the 10-point Brief Pain Inventory. Functional outcome was measured using the Majeed pelvic score. Outcomes were analyzed using hierarchical Bayesian models to compare the average treatment effect from injury to 12 and 52 weeks postinjury. The probability of the mean treatment benefit exceeding a clinically important difference was determined. RESULTS: The 3-month average treatment effect of surgery compared with nonoperative management was a 1.2-point reduction in pain [95% credible interval (CrI): 0.4-1.9] and an 8% absolute improvement in the Majeed score (95% CrI: 3%-14%). Similar results persisted to 1 year. Patients with initial fracture displacement ≥5 mm experienced a larger reduction in pain (2.2, 95% CrI: 0.9-3.5) compared with those patients with less initial displacement (0.9, 95% CrI: 0.1-1.8). CONCLUSION: On average, surgical fixation likely provides a small improvement in pain and functional outcome for up to 12 months. Patients with ≥5 mm of posterior pelvic ring displacement are more likely to experience clinically important improvements in pain. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Quantitative Evaluation of Embolic Load in Femoral and Tibial Shaft Fractures Treated With Reamed Intramedullary Fixation.

OBJECTIVES: To compare the volume of embolic load during intramedullary fixation of femoral and tibial shaft fractures. Our hypothesis was that tibial intramedullary nails (IMNs) would be associated with less volume of intravasation of marrow than IM nailing of femur fractures. DESIGN: Prospective observational study. SETTING: Urban Level I trauma center. PATIENTS/PARTICIPANTS: Twenty-three patients consented for the study: 14 with femoral shaft fractures and 9 with tibial shaft fractures. INTERVENTION: All patients underwent continuous transesophageal echocardiography, and volume of embolic load was evaluated during 5 distinct stages: postinduction, initial guide wire, reaming (REAM), nail insertion, and postoperative. MAIN OUTCOME MEASUREMENTS: Volume of embolic load was measured based on previously described luminosity scores. The embolic load based on fracture location and procedure stage was evaluated using a mixed effects model. RESULTS: The IMN procedure increased the embolic load by 215% (-12% to 442%, P = 0.07) in femur patients relative to tibia patients after adjusting for baseline levels. Of the 5 steps measured, REAM was associated with the greatest increase in embolic load relative to the guide wire placement and controlling for fracture location (421%, 95% confidence interval: 169%-673%, P < 0.01). CONCLUSIONS: Femoral shaft IMN fixation was associated with a 215% increase in embolic load in comparison with tibial shaft IMN fixation, with the greatest quantitative load during the REAM stage; however, both procedures produce embolic load. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

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.