Pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solution in open fractures (Aqueous-PREP): the feasibility of a cluster randomized crossover study.

BACKGROUND: Preoperative antiseptic skin solutions are used prior to most surgical procedures; however, there is no definitive research comparing infection-related outcomes following use of the various solutions available to orthopedic trauma surgeons. The objective of this pilot study was to test the feasibility of a cluster randomized crossover trial that assesses the comparative effectiveness of a 10% povidone-iodine solution versus a 4% chlorhexidine gluconate solution for the management of open fractures. METHODS: Two orthopedic trauma centers participated in this pilot study. Each of these clinical sites was randomized to a starting solution (povidone-iodine solution or chlorhexidine gluconate) then subsequently crossed over to the other treatment after 2 months. During the 4-month enrollment phase, we assessed compliance, enrollment rates, participant follow-up, and accurate documentation of the primary clinical outcome. Feasibility outcomes included (1) the implementation of the interventions during a run-in period; (2) enrollment of participants during two 2-month enrollment phases; (3) application of the trial interventions as per the cluster randomization crossover scheme; (4) participant follow-up; and (5) accurate documentation of the primary outcome (surgical site infection). Feasibility outcomes were summarized using descriptive statistics reported as means (standard deviation) or medians (first quartile, third quartile) for continuous variables depending on their distribution and counts (percentage) for categorical variables. Corresponding 95% confidence intervals (CIs) were also reported. RESULTS: All five of the criteria for feasibility were met. During the run-in phase, all 18 of the eligible patients identified at the two clinical sites received the correct cluster-assigned treatment. A total of 135 patients were enrolled across both sites during the 4-month recruitment phase, which equates to 92% (95% CI 85.9 to 96.4%) of eligible patients being enrolled. Compliance with the assigned treatment in the pilot study was 98% (95% CI 93.5 to 99.8%). Ninety-eight percent (95% CI 93.5 to 99.8%) of participants completed the 90-day post-surgery follow-up and the primary outcome (SSI) was accurately documented for 100% (95% CI 96.6 to 100.0%) of the participants. CONCLUSIONS: These results confirm the feasibility of a definitive study comparing antiseptic solutions using a cluster randomized crossover trial design. Building upon the infrastructure established during the pilot phase, a definitive study has been successfully initiated. TRIAL REGISTRATION: ClincialTrials.gov , number NCT03385304 . Registered December 28, 2017.

A prospective randomized controlled trial of a bioresorbable calcium phosphate paste (alpha-BSM) in treatment of displaced intra-articular calcaneal fractures.

BACKGROUND: Displaced intra-articular calcaneal fractures are devastating injuries and pose a therapeutic challenge. The purpose of this study was to determine whether open reduction internal fixation (ORIF) plus an injectable bioresorbable calcium phosphate paste (alpha-BSM [bone substitute material]) is superior to ORIF alone in the treatment of calcaneal bone voids encountered after operative treatment of displaced intra-articular calcaneal fractures. METHODS: We prospectively randomized 47 patients with 52 closed displaced intra-articular fractures necessitating operative fixation to receive ORIF alone (n = 28) or ORIF plus alpha-BSM (n = 24). The maintenance of Böhler's angle was evaluated at follow-up visits for more than 1 year. Secondary outcome measures included the SF-36 and lower extremity measure every 6 months, and the Oral Analog Scale (OAS) score at 2 years. RESULTS: There was no difference between the groups in the degree of collapse of Böhler's angle at 6 weeks and 3 months when compared with initial postoperative values. However, at 6 months, the mean collapse of the alpha-BSM and ORIF group was 5.6 degree (SD, 4.5 degree) and ORIF alone was 9.1 degree (SD, 5.8 degree), which was statistically significant (p = 0.03). Final radiographic evaluation after 1 year revealed a Böhler's angle loss of 6.2 degree (SD 5.9 degree) and 10.4 degree (SD 7.1 degree) in alpha-BSM and ORIF and ORIF alone groups, respectively, (p = 0.05). There was no difference between the two groups in regards to secondary outcome measures of general health, limb specific function, and pain past 2 years. CONCLUSION: These results support the use of an injectable, in situ hardening calcium phosphate paste to fill the bone void after a displaced intra-articular calcaneal fracture. There was no impact on general health, limb specific function, and pain past 2 years and no associated complications with alpha-BSM use, supporting it safety as an augment to ORIF.

The cost effectiveness of minimally invasive spine surgery in the treatment of adult degenerative scoliosis: a comparison of transpsoas and open techniques.

INTRODUCTION: Surgical treatment improves quality of life in patients with adult degenerative scoliosis (ADS). However, open ADS surgeries are complex, large magnitude operations associated with a high rate of complications. The lateral transpsoas interbody fusion technique is a less invasive alternative to open ADS surgery, but less invasive techniques tend to be more expensive. The objective of this study was to evaluate the cost effectiveness of the transpsoas technique for patients with ADS over a 12-month time horizon from a public payer perspective. METHODS: A cost-effectiveness analysis was performed based on a consecutive case series of patients who underwent ADS surgeries between 2006 and 2012. Effectiveness was expressed as the difference in patient reported preoperative and 12-month postoperative health-related quality of life (HRQOL), which was measured in quality-adjusted life years. Health-care resource use was tabulated based on a clinical chart review on an item-by-item basis. Unit cost data were obtained from published provincial costs in Alberta, Canada. All costs were adjusted to 2015 Canadian dollars. The base case analysis included costs for the surgery, initial hospitalization, and treatment for complications over a 12-month follow-up period. The uncomplicated case analysis included costs for the surgery and initial hospitalization only. The joint uncertainty surrounding the cost and HRQOL differences was estimated using bootstrapping with 10,000 replicates. RESULTS: A total of 10 open technique and 12 transpsoas technique T11-pelvis fusions were included in the analysis. In the base case analysis, the transpsoas technique was less costly compared with the open technique, total cost of $83,513 (95% CI: $72,772-$94,253) versus $111,381 (95% CI: $36,340-$186,423), respectively (incremental cost $27,869), and was associated with 0.06 more quality-adjusted life years and/or patient. However, in the uncomplicated case, the open technique was less costly compared with the transpsoas technique ($47,795 [95% CI: $39,003-$56,586] vs $76,510 [95% CI: $72,273-$80,746]), respectively, with an incremental cost of $28,715. Based on the probabilistic analysis of 10,000 bootstrap iterations for the base case analysis, the transpsoas technique was more effective and less costly compared with the open technique 57% of time. One-way deterministic sensitivity analysis by adjusting bone-morphogenetic protein-2 dosage further improved cost effectiveness of the transpsoas technique by lowering overall costs. CONCLUSIONS: Transpsoas surgeries were associated with better outcomes in terms of HRQOL and lower costs over 1-year follow-up period compared with more invasive open technique. This study should be viewed as a pilot evaluation and should be replicated in a larger prospective multicenter controlled study.

Can Views of the Proximal Femur Be Reliably Used to Predict Malrotation After Femoral Nail Insertion? A Cadaver Validation Study.

INTRODUCTION: We investigated the relationship between the size of the lesser trochanter visualized on an AP view of the hip and femoral rotation after femoral shaft fracture fixation. We hypothesized that the amount of the lesser trochanter visualized can accurately detect differences in femoral shaft rotation. METHODS: Sequential fluoroscopic images of 19 matched pairs of cadaver femora were obtained of the proximal femur at 10° increments of internal and external rotation. The relationship between the percentage of the lesser trochanter and the angle of femoral rotation was assessed by regression analysis. RESULTS: Rotation of the proximal femur follows a relatively linear relationship centered around the neutral rotation position. A 10% change in the lesser trochanter size corresponds to approximately 7° of femoral rotation. CONCLUSION: The relationship between the size of the lesser trochanter visualized and the degree of femoral rotation after femoral shaft fracture fixation is approximately linear and sensitive to relatively small changes in rotation, making it potentially useful for assessing malrotation after femoral shaft fracture fixation.

Early Postoperative Displacement of Combined Pelvic Ring Injury With Acetabular Fracture.

Combined pelvic ring and acetabular injuries present a management challenge. The literature on this topic is scarce, with few outcomes studies available. This retrospective study assessed whether the incidence of postoperative displacement and loss of reduction is higher with combined injuries compared with isolated pelvic ring injuries and isolated acetabular fractures. The charts and radiographs of 33 patients with combined pelvic ring and acetabular fractures treated operatively during a 7-year period at a single institution were reviewed. Pelvic ring and acetabular displacements were measured during the early postoperative period and compared with final follow-up measurements (minimum 5 months after surgery). Measurements also were compared with those from isolated pelvic ring fractures (n=33) and isolated acetabular fractures (n=33). Groups were matched for injury pattern and were propensity-matched by age and Injury Severity Score. Patients with combined injuries and patients with isolated pelvic ring injuries had similar initial pelvic ring reductions on anteroposterior and outlet view radiographs. By final follow-up, the combined injury group had experienced significant additional pelvic ring displacement. The presence of combined injury was an independent risk factor for postoperative pelvic ring displacement. Initial postoperative acetabular displacement was higher in the combined injury group compared with the isolated acetabular fracture group (2.6±1.8 vs 1.1±1.1 mm). By final followup, apparent displacement decreased significantly for both groups. Patients with combined pelvic ring and acetabular fractures were more likely to have poorer acetabular reduction and additional displacement of the pelvic ring component during the postoperative period compared with patients with isolated injuries. [Orthopedics. 2017; 40(3):163-168.].

Does Lumbopelvic Fixation Add Stability? A Cadaveric Biomechanical Analysis of an Unstable Pelvic Fracture Model.

OBJECTIVE: We sought to determine the role of lumbopelvic fixation (LPF) in the treatment of zone II sacral fractures with varying levels of sacral comminution combined with anterior pelvic ring (PR) instability. We also sought to determine the proximal extent of LPF necessary for adequate stabilization and the role of LPF in complex sacral fractures when only 1 transiliac-transsacral (TI-TS) screw is feasible. MATERIALS AND METHODS: Fifteen L4 to pelvis fresh-frozen cadaveric specimens were tested intact in flexion-extension (FE) and axial rotation (AR) in a bilateral stance gliding hip model. Two comminution severities were simulated through the sacral foramen using an oscillating saw, with either a single vertical fracture (small gap, 1 mm) or 2 vertical fractures 10 mm apart with the intermediary bone removed (large gap). We assessed sacral fracture zone (SZ), PR, and total lumbopelvic (TL) stability during FE and AR. The following variables were tested: (1) presence of transverse cross-connector, (2) presence of anterior plate, (3) extent of LPF (L4 vs. L5), (4) fracture gap size (small vs. large), (5) number of TI-TS screws (1 vs. 2). RESULTS: The transverse cross-connector and anterior plate significantly increased PR stability during AR (P = 0.02 and P = 0.01, respectively). Increased sacral comminution significantly affected SZ stability during FE (P = 0.01). Two versus 1 TI-TS screw in a large-gap model significantly affected TL stability (P = 0.04) and trended toward increased SZ stabilization during FE (P = 0.08). Addition of LPF (L4 and L5) significantly improved SZ and TL stability during AR and FE (P < 0.05). LPF in combination with TI-TS screws resulted in the least amount of motion across all 3 zones (SZ, PR, and TL) compared with all other constructs in both small-gap and large-gap models. CONCLUSIONS: The role of LPF in the treatment of complex sacral fractures is supported, especially in the setting of sacral comminution. LPF with proximal fixation at L4 in a hybrid approach might be needed in highly comminuted cases and when only 1 TI-TS screw is feasible to obtain maximum biomechanical support across the fracture zone.

Levels of evidence at the Orthopaedic Trauma Association annual meetings.

OBJECTIVE: To examine the strength of evidence presented at the Orthopaedic Trauma Association (OTA) annual meetings before and after the level of evidence guidelines became popular in the literature. DATA SOURCES: 10 years of abstracts from OTA podium presentations, preguidelines (1998-2002), and postguidelines (2007-2011). STUDY SELECTION: All abstracts were blinded and randomized for review. Only therapeutic, diagnostic, prognostic, and economic study types were included. DATA EXTRACTION: Study type and level of evidence were determined for each abstract. DATA SYNTHESIS: Five hundred thirteen abstracts were included, primarily consisting of therapeutic studies (63%). The distribution of study types between the pre- and postguideline periods was similar (P = 0.37). The levels of evidence for podium presentations in the preguideline period were as follows: level I, 10%; level II, 16%; level III, 14%; and level IV, 60%. The distribution in the postguideline period was as follows: level I, 13%; level II, 2%; level III, 29%; and level IV, 36%. The differences between the pre- and postguideline presentations were significant (P < 0.0001), indicating an improvement in the strength of evidence presented at the annual meetings. CONCLUSIONS: The majority of podium presentations at the OTA annual meetings are level IV studies; however, there has been a measurable decrease in the number of uncontrolled case series presented at more recent meetings. Encouraging reporting of levels of evidence at future annual meetings has the potential to positively influence the orthopaedic trauma community by improving readers' understanding of the strength of evidence presented, the study design hierarchy, and encouraging investigators to conduct controlled study designs when possible.