Syndesmotic Suture Button Fixation Results in Higher Tegner Activity Scale Scores When Compared to Screw Fixation: A Multicenter Investigation.

BACKGROUND: Suture buttons and metal screws have been used and compared in biomechanical, radiographic, and clinical outcome studies for syndesmotic injuries, with neither implant demonstrating clear superiority. The aim of this study was to compare clinical outcomes of both implants. METHODS: Patients who underwent syndesmosis fixation at 2 separate academic centers from 2010 through 2017 were compared. Thirty-one patients treated with a suture button and 21 patients treated with screws were included. Patients in each group were matched by age, sex, and Orthopaedic Trauma Association fracture classification. Tegner Activity Scale (TAS), Foot and Ankle Ability Measure (FAAM), patient satisfaction score, surgical failure, and reoperation rates were compared. RESULTS: Patients who underwent suture button fixation had significantly higher TAS scores than those who underwent screw fixation (p < 0.001). There was no significant difference in FAAM ADL scores between cohorts (p = 0.08). Symptomatic hardware removal rates were similar (3.2% suture button cohort vs 9.0% in screw cohort). One patient (4.5%) underwent revision surgery secondary to syndesmotic malreduction after screw fixation, for a reoperation rate of 13.5%. CONCLUSION: Patients with unstable syndesmotic injuries treated with suture button fixation had higher mean TAS scores compared to patients treated with screws. Foot and Ankle Ability Measure and ADL scores in these cohorts were similar.Level of Evidence: Level 3 Retrospective Matched Case-Cohort.

Small residual fracture gaps delay time to union in length stable femur fractures treated with intrameduallary fixation.

OBJECTIVES: The purpose of this study was to investigate whether residual fracture gapping and translation at time of intramedullary nail (IMN) fixation for diaphyseal femur fractures were associated with delayed healing or nonunion. DESIGN: Retrospective cohort study SETTING: Level 1 trauma hospital, quaternary referral center PATIENTS/PARTICIPANTS/INTERVENTION: Length stable Winquist type 1 and 2 diaphyseal femur fractures treated with IMN at a single Level I trauma center were retrospectively reviewed. MAIN OUTCOME MEASURE: The largest fracture gap and translation were evaluated on immediate anteroposterior (AP) and lateral postoperative radiographs. Radiographic healing was assessed using Radiographic Union Score in Femur (RUSF) scores at each follow-up. Radiographic union was defined as a RUSF score ≥8 and consolidation of at least 3 cortices. ANOVA and student's t-tests were used to evaluate the influence of fracture gap parameters on time to union (TTU) and nonunion rate. Patients were stratified to measured average gap and translation distances <1mm, 1-3mm and >3mm for portions of the analysis. RESULTS: Sixty-six patients who underwent IMN with adequate follow-up were identified. A total of 93.9% of patients achieved union at an average of 2.8 months. Fractures with average AP/lateral gaps of <1mm, 1-2.9 mm, and >3mm had an average TTU of 70.1, 91.7, and 111.9 days respectively; fractures with larger residual gap sizes had a significantly longer TTU (p=0.009). Fractures with an average gap of 1-2.9mm and >3 mm had a significantly higher nonunion rate (1.5% and 4.5% respectively) compared to 0% nonunion in the <1 mm group (p=0.003). CONCLUSION: Residual gapping following intramedullary fixation of length stable diaphyseal femur fractures is associated with a significant increase in likelihood of nonunion. SUMMARY: Residual displacement of length stable femoral shaft fractures following intramedullary nailing can have a significantly negative impact on fracture healing. An average 3 mm AP/lateral residual fracture gap or a total of 6 mm of the AP + lateral fracture gap appeared to be a critical gap size with increased rates of nonunion and time to union. Therefore, we suggest minimizing the sum of the residual AP and lateral fracture gap to less than a total of 6 mm.

A Comparison of the Prevalence of, Demographics of, and Effects on Outcomes of Bilateral Versus Unilateral Femoral Shaft Fractures: A Retrospective Cohort Analysis From the National Trauma Data Bank.

OBJECTIVES: To document the prevalence of, and the effect on outcomes, operatively treated bilateral femur fractures treated using contemporary treatments. DESIGN: A retrospective cohort using data from the National Trauma Data Bank. PARTICIPANTS: In total, 119,213 patients in the National Trauma Data Bank between the years 2007 and 2015 who had operatively treated femoral shaft fractures. MAIN OUTCOME MEASUREMENTS: Complication rates, hospital length of stay (LOS), days in the intensive care unit (ICU LOS), days on a ventilator, and mortality rates. RESULTS: Patients with bilateral femur fractures had increased overall complications (0.74 vs. 0.50, P < 0.0001), a longer LOS (14.3 vs. 9.2, P < 0.0001), an increased ICU LOS (5.3 vs. 2.4, P < 0.0001), and more days on a ventilator (3.1 vs. 1.3, P < 0.0001), when compared with unilateral fractures. Bilateral femoral shaft fractures were independently associated with worse outcomes in all primary domains when adjusted by Injury Severity Score (P < 0.0001), apart from mortality rates. Age-adjusted bilateral injuries were independently associated with worse outcomes in all primary domains (P < 0.0001) except for the overall complication rate. A delay in fracture fixation beyond 24 hours was associated with increased mortality (P < 0.0001) and worse outcomes for all other primary measures (P < 0.0001 to P = 0.0278) for all patients. CONCLUSIONS: Bilateral femoral shaft fractures are an independent marker for increased hospital and ICU LOS, number of days on a ventilator, and increased complication rates, when compared with unilateral injuries and adjusted for age and Injury Severity Score. Timely definitive fixation, in a physiologically appropriate patient, is critical because a delay is associated with worse inpatient outcome measures and higher mortality rates. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Progression of Tibia Fracture Healing Using RUST: Are Early Radiographs Helpful?

OBJECTIVES: To report the progression of radiographic healing after intramedullary nailing of tibial shaft fractures using the Radiographic Union Score for Tibial fractures (RUST) and determine the ideal timing of early postoperative radiographs. DESIGN: Retrospective case series. SETTING: Urban academic Level 1 trauma center. PATIENTS/PARTICIPANTS: Three hundred three patients with acute tibial shaft fractures underwent intramedullary nailing between 2006 and 2013, met inclusion criteria, and had at least 3 months of radiographic follow-up. INTERVENTION: Baseline demographic, injury, and surgical data were recorded for each patient. Each set of postoperative radiographs were scored using RUST and evaluated for implant failure. MAIN OUTCOME MEASUREMENTS: Postoperative time distribution for each RUST score, RUST score distribution for 4 common follow-up time points, and the presence and timing of implant failure. RESULTS: The fifth percentile and median times, respectively, for reaching "any radiographic healing" (RUST = 5) was 4.0 weeks and 8.4 weeks, "radiographically healed" (RUST = 9) was 12.1 and 20.9 weeks, and "healed and remodeled" (RUST = 12) was 23.5 weeks and 47.7 weeks. At 6 weeks, 84% of radiographs were scored as RUST ≤ 6 (2 or fewer cortices with callus). No implant failure occurred within the first 8 weeks after surgery, and the indication for all 7 reoperations within this period was apparent on physical examination or immediate postoperative radiographs. CONCLUSIONS: The median time to radiographic union (RUST = 9) after tibial nailing was approximately 20 weeks, and little radiographic healing occurred within the first 8 weeks after surgery. Routine radiographs in this period may offer little additional information in the absence of clinical concerns such as new trauma, malalignment, or infection. LEVEL OF EVIDENCE: Diagnostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

In-Hospital Morbidity and Mortality With Delays in Femoral Shaft Fracture Fixation.

OBJECTIVES: To investigate trends in the timing of femur fracture fixation in trauma centers in the United States, identify predictors for delayed treatment, and analyze the association of timing of fixation with in-hospital morbidity and mortality using data from the National Trauma Data Bank. METHODS: Patients with femoral shaft fractures treated from 2007 to 2015 were identified from the National Trauma Data Bank and grouped by timing of femur fixation: <24, 24-48 hours, and >48 hours after hospital presentation. The primary outcome measure was in-hospital postoperative mortality rate. Secondary outcomes included complication rates, hospital length of stay (LOS), days spent in the intensive care unit LOS (ICU LOS), and days on a ventilator. RESULTS: Among the 108,825 unilateral femoral shaft fractures identified, 74.2% was fixed within 24 hours, 16.5% between 24 and 48 hours, and 9.4% >48 hours. The mortality rate was 1.6% overall for the group. When fixation was delayed >48 hours, patients were at risk of significantly higher mortality rate [odds ratio (OR) 3.60; 95% confidence interval (CI), 3.13-4.14], longer LOS (OR 2.14; CI 2.06-2.22), longer intensive care unit LOS (OR 3.92; CI 3.66-4.20), more days on a ventilator (OR 5.38; CI 4.89-5.91), and more postoperative complications (OR 2.05; CI 1.94-2.17; P < 0.0001). CONCLUSIONS: Our study confirms that delayed fixation of femoral shaft fractures is associated with increased patient morbidity and mortality. Patients who underwent fixation >48 hours after presentation were at the greatest risk of increased morbidity and mortality. Although some patients require optimization/resuscitation before fracture fixation, efforts should be made to expedite operative fixation. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Proximal Tibia Skeletal Traction: Technique and Indications.

SUMMARY: Skeletal traction is a fundamental tool for the orthopaedic surgeon caring for patients with traumatic pelvic and lower-extremity orthopaedic injuries. Skeletal traction has proven to be an effective initial means of stabilization in patients with these injuries. Traction may be used for both temporary and definitive treatment in a variety of orthopaedic injuries. With the appropriate knowledge of regional anatomy, skeletal traction pins can be placed safely and with a low rate of complications. Several methods for placing skeletal traction have been described, and it is critical for orthopaedic surgeons to be proficient not only in their application but also understanding of the appropriate indications for use. Here we present a case example of a patient with a right femur fracture and discuss the technique and indications for placement of proximal tibia skeletal traction.

Surgical Wound Complications After Percutaneous Posterior Pelvic Ring Fixation in Patients Who Undergo Pelvic Arterial Embolization.

OBJECTIVE: To report on the incidence of surgical wound complications after percutaneous posterior pelvic ring fixation in patients who have also undergone pelvic arterial embolization (PAE) and determine whether the risks outweigh the benefits. DESIGN: Retrospective cohort study. SETTING: Academic level 1 trauma center. PATIENTS: Two hundred one consecutive patients who underwent percutaneous posterior pelvic fixation at our institution were included in this study. Of these, 27 patients underwent pelvic arterial embolization. INTERVENTION: Percutaneous posterior pelvic fixation and pelvic arterial embolization. MAIN OUTCOME MEASUREMENTS: Charts were reviewed for posterior percutaneous surgical wound complications including infection, dehiscence, seroma, tissue necrosis, and return to OR for debridement in all patients. RESULTS: Of the 27 patients who received PAE, none developed posterior surgical wound complications. Of those who did not receive PAE, there was one posterior surgical wound complication documented. There were no cases of wound infection in either group. CONCLUSION: Pelvic arterial embolization can be a valuable intervention in treating hemodynamically unstable patients with pelvic ring injuries. Although even selective pelvic arterial embolization is not entirely benign, there seems to be minimal risk of wound complications when percutaneous posterior pelvic ring fixation is performed. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Kocher-Langenbeck Approach for Posterior Wall Acetabular Fractures.

Adequate surgical exposure is necessary for anatomical reduction and fixation of posterior wall acetabular fractures. This video demonstrates the Kocher-Langenbeck approach to the posterior acetabulum, as well as operative indications, surgical reduction and fixation techniques, and outcomes for posterior wall acetabular fractures.

Are Two-Part Intertrochanteric Femur Fractures Stable and Does Stability Depend on Fixation Method?

OBJECTIVES: To determine stability of 2-part intertrochanteric femur fractures and to determine whether secondary collapse is related to fixation method. DESIGN: A retrospective cohort series. SETTING: Single Level I Trauma Center. PATIENTS: One hundred fourteen patients (82 female) older than 50 years (average age 75 years, range 50-100 years) with an acute low-energy standard obliquity 2-part intertrochanteric femur fracture (OTA/AO 31A) identified from an orthopaedic trauma database were studied. INTERVENTION: Twenty-three patients were treated with a sliding hip screw (dynamic hip screw [DHS]), 53 with a dual screw trochanteric entry nail (INTERTAN), and 38 with a single-blade or screw trochanteric entry intramedullary nail (trochanteric fixation nail [TFN]) based on surgeon choice by 4 fellowship-trained orthopaedic trauma surgeons. MAIN OUTCOME MEASURES: Fracture collapse was measured by comparing immediate postoperative radiographs to those at final follow-up while controlling for magnification and rotation. RESULTS: Collapse averaged 6.8 mm in the DHS group, 3.7 mm in the INTERTAN group, and 7.3 mm in the TFN group. When comparing groups, there was significantly more collapse in the DHS group compared with the INTERTAN group (P = 0.021), and significantly more collapse in the TFN group compared with the INTERTAN group (P < 0.001). Six patients (26%) in the DHS group had >10-mm collapse including 4 (17%) with greater than 20-mm collapse (max = 34.2 mm). Four patients (8%) in the INTERTAN group had >10-mm collapse and none had greater than 12.9 mm. Ten patients (26%) in the TFN group had >10-mm collapse and 3 (5%) had greater than 20-mm collapse (max = 30.7 mm). CONCLUSION: Stability of 2-part intertrochanteric femur fractures is dependent on the fixation device. These fractures are not necessarily stable when treated with a sliding hip screw as 26% treated with this method collapsed greater than 10 mm and 17% more than 20 mm. Dual screw intramedullary nail fixation seems to be most effective to maintain stability for patients with this fracture pattern. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Blunt Thoracolumbar-Spine Trauma Evaluation in the Emergency Department: A Meta-Analysis of Diagnostic Accuracy for History, Physical Examination, and Imaging.

BACKGROUND: Delayed diagnoses of unstable thoracolumbar spine (TL-spine) fractures can result in neurologic deficits and avoidable pain, so it is important for clinicians to reach prompt diagnostic decisions. There are no validated decision aids for determining which trauma patients warrant TL-spine imaging. OBJECTIVE: Our aim was to quantify the diagnostic accuracy of the injury mechanism, physical examination, associated injuries, clinical decision aids, and imaging for evaluating blunt TL-spine trauma patients. METHODS: A search strategy for studies including adult blunt TL-spine trauma using PubMed, Embase, Scopus, CENTRAL, Cochrane Database of Systematic Reviews, and ClinicalTrials.gov was performed. Excluded studies lacked data to construct 2 × 2 tables, were duplicates, were not primary research, did not focus on blunt trauma, examined associated injuries without any utility in identifying TL-spine injuries, only studied cervical-spine fractures, were non-English, had a pediatric setting, or were cadaver/autopsy reports. Risk of bias was assessed using the Quality Assessment Tool for Diagnostic Accuracy Studies. Diagnostic predictors were analyzed with a meta-analysis of sensitivity, specificity, and likelihood ratios. RESULTS: In blunt trauma patients in the emergency department, the weighted pretest probability of a TL-spine fracture was 15%. The estimates for detection of TL-spine fractures with plain film were: positive likelihood ratio (+LR) = 25.0 (95% confidence interval [CI] 4.1-152.2; I2 = 94%; p < 0.001) and negative likelihood ratio (-LR) = 0.43 (95% CI 0.32-0.59; I2 = 84%; p < 0.001), and for computed tomography (CT) were: +LR = 81.1 (95% CI 14.1-467.9; I2 = 87%; p < 0.001) and -LR = 0.04 (95% CI 0.02-0.08; I2 = 23%; p = 0.26). CONCLUSIONS: CT is more accurate than plain films for detecting TL-spine fractures. Injury mechanism, physical examination, and associated injuries alone are not accurate to rule-in or rule-out TL-spine fractures.

Bone marrow aspirate concentrate with cancellous allograft versus iliac crest bone graft in the treatment of long bone nonunions.

OBJECTIVES: The purpose of this study was to compare bone marrow aspirate concentrate (BMAC) with cancellous allograft to iliac crest bone graft (ICBG) in the treatment of long bone nonunions. DESIGN: Retrospective cohort study. SETTING: A single level I trauma center. PATIENTS: 26 patients with long bone diaphyseal or metaphyseal nonunions with defects >2 mm and treated with open repair and BMAC, compared to 25 patients with long bone diaphyseal or metaphyseal nonunions with defects >2 mm and treated with open repair and ICBG. INTERVENTION: Open repair of long bone nonunion using either autologous ICBG or BMAC with cancellous allograft. MAIN OUTCOME MEASURE: Nonunion healing, radiographically measured by the modified Radiographic Union Score for Tibia (mRUST) score. Secondary outcomes included risk factors associated with failed repair. RESULTS: The union rates for the BMAC and ICBG cohorts were 75% and 78%, respectively (P = .8). Infection was the only risk factor of statistical significance for failure. CONCLUSION: In this study, we found no significant difference in union rate for long bone nonunions treated with ICBG or BMAC with allograft. BMAC and allograft led to 75% successful healing in this series. Given the heterogeneity of the control group and loss to follow-up, further prospective investigation should be conducted to more rigorously compare BMAC to ICBG for nonunion treatment. LEVEL OF EVIDENCE: III, retrospective cohort.

Clinical Practice Guidelines in Action: Differences in Femoral Neck Fracture Management by Trauma and Arthroplasty Training.

INTRODUCTION: The purpose of this study was to survey trauma and arthroplasty surgeons to investigate associations between subspecialty training and management of geriatric femoral neck fractures and to compare treatments with the American Academy of Orthopaedic Surgeons clinical practice guidelines. METHODS: Five hundred fifty-six surgeons completed the online survey consisting of two sections: (1) surgeon demographics and (2) two geriatric hip fracture cases with questions regarding treatment decisions. RESULTS: In both clinical scenarios, arthroplasty surgeons were more likely than trauma surgeons to recommend total hip arthroplasty (THA) (case 1: 96% versus 84%; case 2: 29% versus 10%; P ≤ 0.02) and spinal anesthesia (case 1: 70% versus 40%; case 2: 62% versus 38%; P < 0.01). Surgeons who have made changes based on clinical practice guidelines (n = 96; 21% of surveyed) cited more use of THA (n = 56; 58% of respondents) and cemented stems (n = 28; 29% of respondents). CONCLUSION: Arthroplasty surgeons are more likely to recommend THA over hemiarthroplasty and have a higher expectation for spinal anesthesia for the management of geriatric femoral neck fractures.

Vascular Anatomy of the Medial Femoral Neck and Implications for Surface Plate Fixation.

OBJECTIVES: To describe the inferior retinacular artery (IRA) as encountered from an anterior approach, to define its intraarticular position, and to define a safe zone for buttress plate fixation of femoral neck fractures. METHODS: Thirty hips (15 fresh cadavers) were dissected through an anterior (Modified Smith-Petersen) approach after common femoral artery injection (India ink, blue latex). The origin of the IRA from the medial femoral circumflex artery and the course to its terminus were dissected. The IRA position relative to the femoral neck was described using a clock-face system: 12:00 cephalad, 3:00 anterior, 6:00 caudad, and 9:00 posterior. RESULTS: The IRA originated from the medial femoral circumflex artery and traveled within the Weitbrecht ligament in all hips. The IRA positions were 7:00 (n = 13), 7:30 (n = 15), and 8:00 (n = 2). The IRA was 0:30 anterior to (n = 24) or at the same clock-face position (n = 6) as the lesser trochanter. The mean intraarticular length was 20.4 mm (range 11-65, SD 9.1), and the mean extraarticular length was 20.5 mm (range 12-31, SD 5.1). CONCLUSIONS: The intraarticular course of the IRA lies within the Weitbrecht ligament between the femoral neck clock-face positions of 7:00 and 8:00. A medial buttress plate positioned at 6:00 along the femoral neck is anterior to the location of the IRA and does not endanger the blood supply of the femoral head. The improved understanding of the IRA course will facilitate preservation during intraarticular approaches to the femoral neck and head.

Open Reduction and Internal Fixation of the Femoral Head via the Smith-Petersen Approach.

Pipkin described femoral head fractures in the 1950s, but controversy still exists regarding indications for surgery and approaches for operative treatment of femoral head fractures. Clear indications for operative intervention include inability to reduce the hip with closed methods, a nonconcentric reduction, fracture fragments within the articulating surface of the hip, and associated injuries (acetabulum and femoral neck fractures) with their own indications for surgery. The anterior approach described by Smith-Petersen has been modified (using only the distal portion) and used to visualize, clean, reduce, and fix these fractures with and without anterior dislocation of the hip.

ORIF Pilon via Posteromedial and Anterolateral Approaches.

Tibial pilon fractures are complex injuries of soft tissue and bone that challenge patients and surgeons. Outcomes following this injury are guarded, and complications are frequently reported. Soft-tissue compromise at the time of injury is potentially amplified with surgical trauma, necessitating thorough evaluation, preoperative planning, and expertise to minimize complications and maximize outcomes. Understanding angiosome anatomy and typical fracture patterns (and their variations) allows for design of surgical tactics that accomplish these goals.

Distal Tibial Intramedullary Nailing Using an Extraarticular, Lateral Parapatellar Approach in the Semiextended Position.

Semiextended positioning can improve the surgeon's ability to obtain, maintain, and fluoroscopically evaluate a fracture reduction when performing fixation with an intramedullary nail, especially in fractures at the proximal and distal ends. Furthermore, this position allows for evaluation of instrument placement, including the start point, without moving the fluoroscopic unit into extremes of angulation or compromising the quality of the beam orientation. The intraarticular suprapatellar approach has been described as a soft tissue approach to maintain the leg in a position that would not complicate management of these fractures, especially those in the proximal third of the tibia. A semiextended extraarticular soft tissue approach to the start point was described by Kubiak et al, and the lateral parapatellar version has become commonly used on the Orthopaedic Trauma Service at Washington University in Saint Louis. This video demonstrates advantages of semiextended positioning while performing reduction and intramedullary nail fixation for distal tibia fractures. This lateral parapatellar approach can be performed without specialized instrumentation, results in precise establishment of the start point and completion of the fixation without injury to the knee.

Ankle Spanning External Fixator Application.

A 2-stage approach to treatment of tibia pilon fractures was reported in the 1990s and popularized over the ensuing decade to help avoid catastrophic soft-tissue complications experienced with one-stage open reduction and internal fixation. This approach can be expanded to the treatment of other high-energy injuries of the hind foot, with variation in external fixator application as needed. Key factors to maximize the utility and decrease complications of the external fixation stage include the following: (1) anatomic reduction of the talus under the long axis of the tibia in the coronal and sagittal planes, (2) strategic application of Schantz pins to resist deforming forces resulting from the injury, and (3) external fixation outside the zone of injury and definitive surgical treatment. This video demonstrates concepts and tactics to obtain and maintain fracture reduction with an external fixator with examples of a complex combined plafond and talus injury, as well as a more typical Orthopaedic Trauma Association/Arbeitsgemeinschaft fur Osteosynthesefragen C-type pilon fracture.

In-vivo stiffness assessment of distal femur fracture locked plating constructs.

BACKGROUND: The purpose of this study was to design and validate a novel stiffness-measuring device using locked plating of distal femur fractures as a model. METHODS: All patients underwent a laterally-based approach, with a bridging locked construct after indirect reduction. A custom and calibrated intraoperative stiffness device was applied and the stiffness of the construct was blindly recorded. Fourteen of twenty-seven patients enrolled with distal femur fractures (AO/OTA 33A and 33C) completed the study. Correlations between stiffness and callus formation, working length, working length/plate length ratio, number of distal locking screws, and fracture pattern were explored. FINDINGS: Callus and modified radiographic union scale in tibias scores as a linear function of stiffness did not correlate (R2 = 0.06 and 0.07, respectively). Construct working length and working length to plate length ratio did not correlate to stiffness (R2 = 0.18 and 0.16 respectively). A combined delayed and nonunion rate was 14%. Lower extremity measure scores were not statistically different when comparing delayed and nonunion with healed fractures. INTERPRETATION: The lack of correlation may have been due to the mechanical properties of the plate itself and its large contribution to the overall stiffness of the construct. To our knowledge, clinically relevant stiffness has not been described and this study may provide some estimates. This methodology and these preliminary findings may lay the groundwork for further investigations into this prevalent clinical problem. Other parameters not investigated may play a key role such as body mass index and bone mineral density. LEVEL OF EVIDENCE: Diagnostic/Prognostic Level II.