Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
ImportanceUnstable chest wall injuries have high rates of mortality and morbidity. In the last decade, multiple studies have reported improved outcomes with operative compared with nonoperative treatment. However, to date, an adequately powered, randomized clinical trial to support operative treatment has been lacking.ObjectiveTo compare outcomes of surgical treatment of acute unstable chest wall injuries with nonsurgical management.Design, Setting, and ParticipantsThis was a multicenter, prospective, randomized clinical trial conducted from October 10, 2011, to October 2, 2019, across 15 sites in Canada and the US. Inclusion criteria were patients between the ages of 16 to 85 years with displaced rib fractures with a flail chest or non–flail chest injuries with severe chest wall deformity. Exclusion criteria included patients with significant other injuries that would otherwise require prolonged mechanical ventilation, those medically unfit for surgery, or those who were randomly assigned to study groups after 72 hours of injury. Data were analyzed from March 20, 2019, to March 5, 2021.InterventionsPatients were randomized 1:1 to receive operative treatment with plate and screws or nonoperative treatment.Main Outcomes and MeasuresThe primary outcome was ventilator-free days (VFDs) in the first 28 days after injury. Secondary outcomes included mortality, length of hospital stay, intensive care unit stay, and rates of complications (pneumonia, ventilator-associated pneumonia, sepsis, tracheostomy).ResultsA total of 207 patients were included in the analysis (operative group: 108 patients [52.2%]; mean [SD] age, 52.9 [13.5] years; 81 male [75%]; nonoperative group: 99 patients [47.8%]; mean [SD] age, 53.2 [14.3] years; 75 male [76%]). Mean (SD) VFDs were 22.7 (7.5) days for the operative group and 20.6 (9.7) days for the nonoperative group (mean difference, 2.1 days; 95% CI, −0.3 to 4.5 days; P = .09). Mortality was significantly higher in the nonoperative group (6 [6%]) than in the operative group (0%; P = .01). Rates of complications and length of stay were similar between groups. Subgroup analysis of patients who were mechanically ventilated at the time of randomization demonstrated a mean difference of 2.8 (95% CI, 0.1-5.5) VFDs in favor of operative treatment.Conclusions and RelevanceThe findings of this randomized clinical trial suggest that operative treatment of patients with unstable chest wall injuries has modest benefit compared with nonoperative treatment. However, the potential advantage was primarily noted in the subgroup of patients who were ventilated at the time of randomization. No benefit to operative treatment was found in patients who were not ventilated.Trial RegistrationClinicalTrials.gov Identifier: NCT01367951
Background: Kneeling posterior cruciate ligament (PCL) stress radiographs are commonly used to evaluate PCL laxity. Patients, however, report significant pain, and the method’s reproducibility may be challenged due to its dependence on patient body weight distribution to produce posterior tibial displacement. Weighted gravity stress radiography may offer better reproducibility and comfort than the kneeling technique, but its efficacy has not been studied. Hypothesis: Weighted gravity PCL stress radiographs will be more comfortable and produce similar measurements of side-to-side difference in posterior tibial displacement when compared with the kneeling technique. Study Design: Cohort study (diagnosis); Level of evidence, 3. Methods: A total of 40 patients with nonoperatively or >6 months postoperatively treated PCL injuries (isolated or multiligamentous) underwent bilateral stress radiographs. Weighted gravity and kneeling stress radiographs were acquired, in random order, for each patient, as well as side-to-side difference in posterior tibial displacement between each knee, patient-reported visual analog scale knee pain (100 mm), time to acquire the images, and patient preference for technique. Paired t tests were used to compare the side-to-side difference, pain score, and time to complete the radiographs. Results: There was no difference between the 2 radiographic methods in the mean side-to-side difference (gravity: 6.45 ± 4.61 mm, kneeling: 6.82 ± 4.60 mm; P = .72), time required to acquire radiographs (kneeling: 307.3 ± 140.5 seconds, gravity: 318.7 ± 151.1 seconds; P = .073), or number of radiographs taken to obtain acceptable images (kneeling: 3.6 ± 1.6, gravity: 3.7 ± 1.7; P = .73). Patients reported significantly less knee pain during the weighted gravity views (kneeling: 31.8 ± 26.6, gravity: 4.0 ± 12.0; P < .0001). Of the patients, 88% preferred the weighted gravity method. Conclusion: Weighted gravity stress radiographs produce similar side-to-side differences in posterior tibial translation compared with the kneeling stress technique, but do not rely on patient weightbearing and provide significantly better patient comfort. Clinicians should therefore consider the use of weighted gravity stress radiographs in clinical practice to minimize the pain associated with stress radiography while allowing for accurate decision making.
Objectives: To determine whether single or double screw (DS) fixation of medial malleolar fractures results in better long-term health outcomes. Design: Randomized clinical trial; sealed envelope technique. Setting: Level 1 Trauma Hospital at University of Calgary, Canada. Patients: One hundred forty patients were randomized to receive either 1 or 2 screws to reduce a medial malleolar fracture. Thirteen patients were excluded because of loss to follow-up (n = 127). Intervention: Surgical fixation of the medial malleolar fracture was performed using 1 or 2 stainless steel screws. Main Outcome Measurements: Primary outcome was comparison of physical functioning summary score on Short Form 36 questionnaires between patients in the 2 groups. Secondary objectives were to compare the Ankle Hindfoot Scale and operating room time. Clinical and radiographic assessment occurred at the time of injury and 2, 6 weeks, 3, 6, 12, and 24 months postoperatively. Results: Fourteen patients crossed over from the DS group to the single screw (SS) group based on intraoperative decisions by the surgeon (fragment too small for 2 screws), leaving the SS (n = 75) and DS groups (n = 52). There was no difference in the operating room time, SF36, or Ankle Hindfoot Scale at all follow-up time points. Conclusions: SS medial malleolar fixation provides an equally safe and effective method of fracture care as compared to DS fixation. Twenty percent of patients receiving 2 screws can be expected to crossover to receive SS fixation as a safer alternative. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Objectives: Kneeling stress radiographs are commonly used to evaluate posterior cruciate ligament (PCL) laxity. Patients, however, report significant pain, and reproducibility is challenged due to its dependence on patient body weight distribution to produce posterior tibial displacement (PTD). Weighted gravity stress radiographs may offer better reproducibility and comfort than the kneeling technique, but its efficacy has not been studied. Hypothesis: weighted gravity radiographs will be more comfortable and produce similar PTD measurements when compared to the kneeling technique. Methods: Patients 18-70 years old with non-operatively or >6 months post-operatively treated PCL injuries (isolated or multi-ligamentous) were recruited from two academic level one trauma centers to undergo bilateral PCL stress radiographs. Exclusions: open/bilateral injuries, fractures. Patients underwent PCL stress radiographs by two randomly ordered methods. Kneeling stress views: patients knelt on padded scales (separate for each knee) with the padding distal to the tibial tubercle. Patients were verbally encouraged to place equal weight on both knees (scale outputs not visible to the patient). A digital radiography plate was placed between the legs to acquire bilateral lateral radiographs. Weighted gravity stress views: Patients lay supine with their hip and knee at 90°with the heel supported. A 20 lb weight was placed on the anterior tibia just distal to the tibial tubercle. A lateral radiograph was taken and then repeated on the contralateral leg. Images were anonymized and uploaded to PACS for measurement. Outcomes: side to side difference (SSD) in translation of the posterior tibial condyles relative to the posterior femoral condyles (primary outcome); patient-reported VAS knee pain (100 mm) during the radiographs; time required to acquire the images; patient preference for technique. Statistics: sample size = 31 patients to detect a 2 mm difference (α=0.05, power 80%, SD = 2.8 mm [Jung, 2006]). Paired t-tests were used to compare the SSD between the kneeling and weighted gravity methods, VAS pain, and time to complete the radiographs. Results: 40 patients (77.5% male, 34.5 ± 12.8yrs old, 65% left knee) were recruited. 42.5% had undergone PCL reconstruction. There was no difference between the two radiographic methods in the mean SSD (kneeling = 6.29 ± 4.58 mm, gravity = 6.82 ± 4.60 mm, p= 0.61). There was no difference in the total time required to perform the radiographs (kneeling = 307.3 s ± 140.5 s, gravity = 318.7 s ± 151.1 s, p= 0.73) or the number of radiographs taken to obtain acceptable images (kneeling = 3.6 ± 1.6, gravity = 3.7 ± 1.7, p= 0.73). The amount of weight placed on each knee during the kneeling views differed slightly but was not significant (affected = 21.5 ± 11.3 kg, unaffected = 26.1 ± 12.1 kg, p= 0.09). There was significantly less knee pain reported for the gravity views (kneeling = 31.8 ± 26.6, gravity = 4.0 ± 12.0, p < 0.0001). 94.6% of patients preferred the gravity method. Conclusion: Weighted gravity PCL stress radiographs should be considered for use in clinical practice as they produce similar posterior tibial translation values to the kneeling technique, do not rely on patient weightbearing, and provide significantly better patient comfort.
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