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 The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation.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.

Comparison of Curved and Straight Anchor Insertion for Bankart Repair.

The quality of Bankart repair may be compromised by the presence of glenoid perforation during suture anchor placement. The purpose of this study was to compare the rate of glenoid perforation and biomechanical strength of antero-inferior suture anchors placed with a curved vs a traditional straight technique through an anteroinferior portal. Ten bilateral pairs of fresh human cadaveric shoulders were randomized to either a curved or a straight suture anchor insertion technique. An anteroinferior portal was used to place a 1.5-mm soft anchor in the anteroinferior glenoid (5:30 position for right shoulders). Anatomic dissection was performed, and the maximum load of each anchor was measured using a materials testing system. The overall rate of glenoid perforation by the anteroinferior anchor was 50%. The rate of glenoid perforation was 40% in the straight group and 60% in the curved group (P=.41). The median maximum load was 86 N in the straight group and 137 N in the curved group (P=.23). The median maximum load of the anchors that did perforate the glenoid was 102 N and of those that did not was 118 N (P=.72). The mode of failure was suture anchor pullout in all except one specimen. The curved guide was not superior to the traditional straight guide in terms of the rate of glenoid perforation or the maximum load of the suture anchors. Anterior cortical perforation of the glenoid during anteroinferior suture anchor placement is common with both techniques. [Orthopedics. 2019; 42(2):e242-e246.].

Comparison of Curved and Straight Anchor Insertion for SLAP Repair: A Cadaveric Study.

PURPOSE: To compare a curved drill guide with a straight guide for suture anchor placement into the posterosuperior glenoid from an anterolateral portal with respect to glenoid perforation, drill contact with the suprascapular nerve, and maximum load. METHODS: Ten bilateral pairs of fresh human cadaveric shoulders were randomized to the curved technique on 1 side and the straight technique on the contralateral side. An anterolateral trans-rotator cuff portal was used for placement of anchors at the posterior (11 o'clock right shoulder) and far posterior (10 o'clock right shoulder) positions on the glenoid with a 24-mm drill stop, and the drill tip was marked with ink. Specimens were dissected for glenoid perforation and drill contact with the suprascapular nerve. The maximum load of each anchor was measured using a material testing system. RESULTS: Glenoid perforation occurred in 30% in the curved group and 60% in the straight group overall (P = .01). Ink markings demonstrated a direct hit on the suprascapular nerve in most of the penetrations (13 of 18) but was not significantly different between the curved and straight guides (P = .25). Maximum load of the posterior anchor was greater in the curved group than that in the straight group (199.5 vs 146.7 N, respectively; P = .01). CONCLUSIONS: The curved technique has a lower rate of glenoid perforation and greater maximum load than the straight technique. However, the curved technique can result in glenoid perforation and injury to the suprascapular nerve, and we do not recommend it. CLINICAL RELEVANCE: Placing suture anchors through an anterolateral portal with a curved guide provides a more optimal trajectory with decreased risk of glenoid perforation and superior biomechanical strength than that with the straight guide, but it is not safe.

Postoperative Deep Vein Thrombosis, Pulmonary Embolism, and Myocardial Infarction: Complications After Therapeutic Anticoagulation in the Patient With Spine Trauma.

STUDY DESIGN: A retrospective review (2001-2014) was conducted using prospectively collected data at a level I trauma center. OBJECTIVE: We sought to determine the incidence and characteristics of complications occurring secondary to therapeutic anticoagulation in adult spine trauma patients. SUMMARY OF BACKGROUND DATA: Numerous studies have assessed prophylactic anticoagulation after spine surgery, but none has investigated the risks of therapeutic doses of anticoagulation for treatment of postoperative thromboembolic events. METHODS: Patients were included if they sustained a postoperative thromboembolic event (deep venous thrombosis, pulmonary embolism, or myocardial infarction). Patients were excluded if anticoagulation was subtherapeutic. Of 1712 patients, 62 who received therapeutic anticoagulation and 174 propensity-matched control patients who did not receive therapeutic anticoagulation were included in the study. RESULTS: Initial anticoagulation was obtained by heparin infusion (51%), low-molecular-weight heparin (LMWH, 46%), and warfarin (3%). Complications requiring unplanned reoperation occurred in 18% of anticoagulated patients and 10% of nonanticoagulated patients (P = 0.17). The reoperation rate after heparin infusion was 31% and after LMWH was 6.5% (P = 0.02). Epidural hematoma occurred in 3% and 1% of anticoagulated and nonanticoagulated patients, respectively. Multivariate logistic regression analysis of the two groups showed a trend toward increased risk of reoperation in the anticoagulation group. Analysis of the heparin infusion subgroup separate from the LMWH subgroup compared with the control group showed an increased risk of reoperation for any complication (odds ratio, 3.57; P = 0.01) and for bleeding complications (odds ratio, 43.1; P = 0.01). CONCLUSION: This is the first study to quantify complications secondary to postoperative therapeutic anticoagulation in spine patients. Postoperative spine trauma patients who underwent therapeutic anticoagulation experienced an unplanned reoperation rate of 18%, including a 3% incidence of spinal epidural hematoma. Therapeutic anticoagulation using heparin infusion seems to drive the overall rate of reoperation (31%) compared with LMWH. LEVEL OF EVIDENCE: 3.

Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High-Energy Fracture Surgery (OXYGEN Study).

Supplemental perioperative oxygen (SPO) therapy has been proposed as one approach for reducing the risk of surgical site infection (SSI). Current data are mixed regarding efficacy in decreasing SSI rates and hospital inpatient stays in general and few data exist for orthopaedic trauma patients. This study is a phase III, double-blind, prospective randomized clinical trial with a primary goal of assessing the efficacy of 2 different concentrations of perioperative oxygen in the prevention of SSIs in adults with tibial plateau, pilon (tibial plafond), or calcaneus fractures at higher risk of infection and definitively treated with plate and screw fixation. Patients are block randomized (within center) in a 1:1 ratio to either treatment group (FiO2 80%) or control group (FiO2 30%) and stratified by each study injury location. Secondary objectives of the study are to compare species and antibacterial sensitivities of the bacteria in patients who develop SSIs, to validate a previously developed risk prediction model for the development of SSI after fracture surgery, and to measure and compare resource utilization and cost associated with SSI in the 2 study groups. SPO is a low cost and readily available resource that could be easily disseminated to trauma centers across the country and the world if proved to be effective.

Knee Donor Site Morbidity Following Harvest of Medial Femoral Trochlea Osteochondral Flaps for Carpal Reconstruction.

PURPOSE: This study examines donor site morbidity associated with the medial femoral trochlea (MFT) when used as a donor site for vascularized osteochondral flaps for reconstruction of challenging carpal defects such as proximal pole scaphoid nonunion and advanced Kienböck disease. METHODS: The retrospective study population included all patients who had undergone MFT flap harvest for scaphoid or lunate reconstruction. Chart review, patient questionnaires, and validated knee function assessment tools were used: International Knee Documentation Committee Subjective Knee Form scores ranged from 0 (maximal disability) to 100 (no disability). Western Ontario and McMaster Universities osteoarthritis index scores ranged from 0% (no disability) to 100% (maximal disability). Magnetic resonance imaging and radiographs were obtained on the donor knee on the majority of patients. RESULTS: Questionnaire response rate was 79% (45 of 57 patients). Average patient age was 35 ± 11 years (range, 19-70 years). Average postoperative follow-up was 27 ± 17 months (range, 9-108 months). The indication for MFT flap reconstruction was scaphoid nonunion in 30 patients and Kienböck disease in 15 patients. All 45 patients had a stable knee on examination. Magnetic resonance and radiographic imaging obtained on 35 patients exhibited no pathological changes. Average duration of postoperative pain was 56 ± 59 days (range, 0-360 days); average duration until patients reported the knee returning to normal was 90 ± 60 days (range, 14-360 days). Forty-three of 44 patients would have the same surgery again if needed; overall satisfaction with the surgery was rated as 5 ± 1 (range, 2-5) on a scale from 0 (no satisfaction) to 5 (maximal satisfaction). Average International Knee Documentation Committee score was 96 ± 9 (range, 56.3-100) and the average Western Ontario and McMaster Universities score was 6% ± 16% (range, 0%-68%). CONCLUSIONS: Medial femoral trochlea osteochondral flap harvest results in minimal donor site morbidity in the majority of patients. Symptoms are time limited. Intermediate-term follow-up demonstrates excellent results in subjective outcome measures. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

Septic Arthritis and Osteomyelitis Caused by Pasteurella multocida.

This report presents a case of progressive septic arthritis and osteomyelitis caused by a rare pathogen, Pasteurella multocida, thought to be provoked by the use of systemic corticosteroids. Despite initial improvement after antibiotics and surgical procedure, the patient returned with new, associated symptoms 1 month later. This concurrent set of circumstances leading to a life-threatening condition has not been reported, to the best of our knowledge. Physicians aware of such a case will be better prepared to diagnose, treat, and educate their patients. Additionally, the diagnostic challenge presented by this case report emphasizes the need for vigilance and thoroughness in obtaining histories from patients presenting with seemingly benign complaints, especially in vulnerable populations, such as infants, pregnant women, and immunocompromised adults.

Upper extremity injuries in motorcyclists: Implications for mortality and need for rehabilitation services.

BACKGROUND: Motorcycle crashes (MCCs) constitute a disproportionately high number of road accidents that result in mortality and injury, compared with other motor vehicle collisions. Distribution and characteristics of upper extremity injuries sustained by motorcyclists and their implications are not well established. We sought to determine the epidemiology of upper extremity injuries in motorcyclists and the independent effects of the injuries on mortality and need for rehabilitative services. METHODS: All motorcyclist admissions at our Level I trauma center from 2006 through 2010 were retrospectively reviewed. We identified and categorized all upper extremity injuries. Demographic data, in-hospital mortality, disposition to a rehabilitation facility, and other potential confounding covariates were recorded. Propensity score-adjusted logistic regression models quantified the effects of upper limb injuries on mortality and transfer to rehabilitation facilities. RESULTS: Thirty-five percent (759 of 2,151 patients) involved in MCCs sustained upper extremity injury. Shoulder girdle injuries were most common (n = 433), followed by forearm fractures (n = 272). Mortality rate was 4% (87 of 2,151 patients) for all MCC admissions. Propensity score-adjusted logistic regression models showed that injuries distal to the humerus had an independent odds ratio for mortality of 0.41 (95% confidence interval, 0.21-0.8). Odds of requiring rehabilitation after discharge were 1.82 times (95% confidence interval, 1.47-2.26) higher when any upper extremity injury was sustained. CONCLUSION: Upper extremity injuries are common in MCCs. Distal injuries are associated with lower mortality rates possibly because of a "crumple zone effect" of distal upper extremities sparing the head and neck region from direct impact in head-first injuries. MCC patients with upper extremity injuries are more likely to require rehabilitation services. LEVEL OF EVIDENCE: Epidemiologic study, level III.

Current rates of publication for podium and poster presentations at the american society for surgery of the hand annual meetings.

BACKGROUND: Research projects are presented at the Annual Meetings of the American Society for Surgery of the Hand (ASSH). It is unknown how many achieve publication in peer-reviewed journals. We sought to determine current rates of publication of podium and poster presentations. METHODS: All ASSH podium and poster presentations from 2000 to 2005 were reviewed, and an Internet-based search using PubMed and Google was conducted to determine whether the presented studies had been published. Times to publication and journal names were recorded. Data were analyzed with descriptive statistics. Fisher's exact test was conducted to compare current trends with previous trends. RESULTS: Of 1127 podium and poster presentations reviewed, 46% were published in peer-reviewed journals. Forty-seven percent of published presentations (242 presentations) were in Journal of Hand Surgery, and 11% (59 presentations) were in Journal of Bone and Joint Surgery. Forty-five percent of presentations were published within 2 years and 66% within 3 years. The publication rate for podium presentations was significantly higher than that previously reported for Journal of Hand Surgery, at 54% compared with 44% (P=0.004). CONCLUSIONS: Currently, fewer than half of the studies presented at Annual Meetings of the ASSH achieve publication in peer-reviewed journals. Presentations are most likely to be published within 3 years, and almost half are published in Journal of Hand Surgery.

Salvage of upper extremities with humeral fracture and associated brachial artery injury.

BACKGROUND: Humeral fractures with brachial artery injury present a challenge for treating surgeons. Treatment practices vary, including use of vascular shunts, multispecialty teams versus an upper-extremity surgeon, and temporizing external fixation. Our objectives were to describe our treatment approach, to define "absolute ischaemia," to determine whether to use a vascular shunt, and to identify variables that could improve limb salvage rate. METHODS: We conducted a retrospective study of 38 patients with humeral fracture and brachial artery injury from 1999 through 2012 at a level I trauma centre. Demographic and treatment characteristics were compared between blunt and penetrating injuries and between treatment by multispecialty teams and treatment by an upper-extremity surgeon. We investigated other variables of interest, including immediate internal fixation, shunt use, time to brachial artery repair, and flap coverage. This study focused on immediate limb salvage and not on eventual functional outcomes of the limb or patient satisfaction regarding the extremity. The main outcome measure was salvage versus amputation. RESULTS: Thirty-six upper extremities were successfully salvaged, and two underwent eventual amputation. Immediate internal fixation (33 of 38 patients) did not have an adverse effect on the rate of successful limb salvage (p > .05). Shunt use and treatment by an upper-extremity surgeon were not associated with improved salvage rate (p > .05). The need for flap coverage was significantly associated with failed salvage of the extremity (p = .02). CONCLUSIONS: Salvage of the upper extremity with humeral fracture and associated brachial artery injury is not dependent on time to brachial artery repair, shunt use, or specialty of treating surgeon. Immediate internal fixation can be performed without adversely affecting the potential for successful salvage. Flap coverage, which is an indicator of severity of soft-tissue injury, correlates with amputation in these severe injuries. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic III.

Injury to the suprascapular nerve during superior labrum anterior and posterior repair: is a rotator interval portal safer than an anterosuperior portal?

PURPOSE: The purpose of this study was to compare the risk of injury to the suprascapular nerve during suture anchor placement in the glenoid when using an anterosuperior portal versus a rotator interval portal. METHODS: Ten bilateral fresh human cadaveric shoulders were randomized to anchor placement through the anterosuperior portal on one shoulder and the rotator interval portal on the contralateral shoulder. Standard 3 × 14 mm suture anchors were placed in the glenoid rim (1 o'clock, 11 o'clock, and 10 o'clock positions for the right shoulder). The suprascapular nerve was dissected. When glenoid perforation occurred, the distance from the anchor tip to the suprascapular nerve, the distance from the glenoid rim to the suprascapular nerve, and the drill-hole depth at each entry site were recorded. RESULTS: All far-posterior anchors perforated the glenoid rim when using the anterosuperior or rotator interval portal. The distance from the far-posterior anchor tip to the suprascapular nerve averaged 8 mm (range, 3.4 to 14 mm) for the anterosuperior portal and 2.1 mm (range, 0 to 5.5 mm) for the rotator interval portal (P ≤ .001). CONCLUSIONS: Using an anterosuperior or rotator interval portal results in consistent penetration of 1 o'clock and 2 o'clock posterior anchors and might place the suprascapular nerve at risk of iatrogenic injury. Based on closer proximity of the anchor tip to the suprascapular nerve, the risk of injury is significantly greater with a rotator interval portal. CLINICAL RELEVANCE: Using a rotator interval portal for suture anchor placement in the posterior aspect of the glenoid rim can lead to a higher likelihood of suprascapular nerve injury.

Perioperative supplemental oxygen to reduce surgical site infection after open fixation of high-risk fractures: a randomized controlled pilot trial.

BACKGROUND: Higher concentrations of fraction of inspired oxygen (FIO2) have been shown to be associated with lower risk for surgical site infection in multiple studies outside the domain of orthopedic surgery. We evaluated the efficacy of high FIO2 administered during the perioperative period to reduce the rate of surgical site infection after open fixation of lower-extremity fractures at high risk of infection. METHODS: We conducted a randomized controlled, parallel design, double-blind study. Patients sustaining high-energy tibial plateau, tibial pilon, and calcaneus fractures treated in a staged fashion were selected for enrollment because these injuries are associated with high risk of infection. The study population included 222 patients with 235 fractures. Consenting patients were randomized by random number sequence to either the treatment or the control group. Treatment group patients received 80% FIO2 intraoperatively and for 2 hours afterward. Control group patients received 30% FIO2 during the same period. Surgeons, patients, and personnel who performed wound assessments were blinded to group assignment. The primary outcome measure was surgical site infection as defined by the Centers for Disease Control criteria for postoperative wound infection. RESULTS: The overall rates of postoperative surgical site infection were 12% (14 of 119 fractures) in the treatment group and 16% (19 of 116 fractures) in the control group (p = 0.31). Multivariate analysis, accounting for risk factors for infection, yielded the closest to a statistically significant reduction in the odds of infection with treatment (odds ratio, 0.54; p = 0.17). No treatment-associated events were observed. CONCLUSION: Use of a high concentration of FIO2 during the perioperative period is safe and shows a trend toward reduction of surgical site infection in patients undergoing open operative fixation of high-energy traumatic lower-extremity fractures. Further study in a larger patient population is indicated. LEVEL OF EVIDENCE: Therapeutic study, level III.

Predictive model for surgical site infection risk after surgery for high-energy lower-extremity fractures: development of the risk of infection in orthopedic trauma surgery score.

BACKGROUND: Current infection risk scores are not designed to predict the likelihood of surgical site infection after orthopedic fracture surgery. We hypothesized that the National Nosocomial Infections Surveillance (NNIS) System and the Study on the Efficacy of Nosocomial Infection Control (SENIC) scores are not predictive of infection after orthopedic fracture surgery and that risk factors for infection can be identified and a new score created (Emerg Infect Dis. 2003;9:196-203). METHODS: We conducted a secondary analysis of data from a trial involving internal fixation of 235 tibial plateau, pilon, and calcaneus fractures treated between 2007 and 2010 at a Level I trauma center. The predictive value of the NNIS System and SENIC scores was evaluated based on areas under the receiver operating characteristic (ROC) curve. Bivariate and multiple logistic regression analyses were used to build an improved prediction model, creating the Risk of Infection in Orthopedic Trauma Surgery (RIOTS) score. The predictive value of the RIOTS score was evaluated via the ROC curve. RESULTS: NNIS System and SENIC scores were not predictive of surgical site infection after orthopedic fracture surgery. In our final regression model, the relative odds of infection among patients with AO [Arbeitsgemeinschaft für Osteosynthesefragen] type C3 or Sanders type 4 fractures compared with fractures of lower classification was 5.40. American Society of Anesthesiologists class 3 or higher and body mass index less than 30 were also predictive of infection, with odds ratios of 2.87 and 3.49, respectively. The area under the ROC curve for the RIOTS score was 0.75, significantly higher than the areas for the NNIS System and SENIC scores. CONCLUSION: The NNIS System and SENIC scores were not useful in predicting the risk of infection after fixation of fractures. We propose a new score that incorporates fracture classification, American Society of Anesthesiologists classification, and body mass index as predictors of infection. LEVEL OF EVIDENCE: Prognostic study, level II.

Acute exertional lumbar paraspinal compartment syndrome.

STUDY DESIGN: A case report and review of the literature. OBJECTIVE: To report a rare case of paraspinal compartment syndrome that presented a diagnostic challenge. SUMMARY OF BACKGROUND DATA: Paraspinal compartment syndrome is a rare condition defined as increased pressure within a closed fibro-osseous space, resulting in reduced blood flow and tissue perfusion in that space. The reduced perfusion causes ischemic pain and irreversible damage to the tissues of the compartment if unrecognized or left untreated. METHODS: A 20-year-old African-American man presented with 2 days of new-onset progressive back pain after repetitive lifting of 235 lbs in a deadlift exercise. The patient had significantly tender lumbar paraspinal muscles, was unable rise from a supine position, and had severe pain with attempted active rolling or sitting. Findings of supine radiographs were normal. Findings of initial laboratory investigations were consistent with rhabdomyolysis and acute kidney injury. Despite aggressive hydration and narcotic analgesia, the patient's creatinine kinase and myoglobin continued to rise and his pain continued to worsen. Computed tomography of the spine revealed enlarged paraspinal musculature and decreased enhancement bilaterally. Gadolinium-enhanced magnetic resonance imaging of the spine showed increased T2 signal and paraspinal muscle edema with areas of decreased contrast uptake, consistent with ischemia and necrosis. Compartment pressures measured 78 mm Hg on the left and 26 mm Hg on the right. RESULTS: Because hydration and analgesia had failed, the patient was taken urgently to the operating room for bilateral paraspinal fasciotomies with delayed closure. His symptoms and rhabdomyolysis then resolved during the next 2 days. CONCLUSION: The diagnostic challenge presented by this case, especially considering the rarity of paraspinal compartment syndrome, indicates the need for a high index of suspicion in the appropriate setting.

Use of 2 column screws to treat transcondylar distal humeral fractures in geriatric patients.

We describe fixation of transcondylar distal humeral fractures with column screws in geriatric patients and review our initial results. We conducted a retrospective review of a prospectively collected database at a Level I trauma center. Six patients met inclusion criteria of age older than 65 years and treatment of minimally or nondisplaced transcondylar distal humeral fracture with column screws only. All were closed fractures with no associated nerve injuries. One patient was lost to follow-up. The mechanism of injury was low-energy fall for the 5 remaining patients (average age, 74 y; age range, 70 to 83 y; average follow-up duration, 10.6 wk). One patient had a traumatic brain injury and a contralateral metacarpal fracture that was treated with internal fixation. The remaining 4 patients sustained isolated distal humeral fractures. No complications were noted, and all fractures healed at an average radiographic union time of 7.2 weeks. Average range of motion was 22 degrees extension [95% CI (-1.47, 45.47)], 114 degrees flexion [95% CI (89.4, 138.6)], and 92 degrees arc of motion [95% CI (58.68, 125.38)]. Treatment of select transcondylar distal humeral fractures with column screws in geriatric patients provides an option for stable fixation that allows early range of motion with minimal surgical morbidity.