Summary Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. Findings Between March 3, 2008, and March 31, 2014, we randomly assigned 1108 patients to receive a sliding hip screw (n=557) or cancellous screws (n=551). Reoperations within 24 months did not differ by type of surgical fixation in those included in the primary analysis: 107 (20%) of 542 patients in the sliding hip screw group versus 117 (22%) of 537 patients in the cancellous screws group (hazard ratio [HR] 0.83, 95% CI 0.63–1.09; p=0.18). Avascular necrosis was more common in the sliding hip screw group than in the cancellous screws group (50 patients [9%] vs 28 patients [5%]; HR 1.91, 1.06–3.44; p=0.0319). However, no significant difference was found between the number of medically related adverse events between groups (p=0.82; appendix); these events included pulmonary embolism (two patients [<1%] vs four [1%] patients; p=0.41) and sepsis (seven [1%] vs six [1%]; p=0.79). Interpretation In terms of reoperation rates the sliding hip screw shows no advantage, but some groups of patients (smokers and those with displaced or base of neck fractures) might do better with a sliding hip screw than with cancellous screws. Funding National Institutes of Health, Canadian Institutes of Health Research, Stichting NutsOhra, Netherlands Organisation for Health Research and Development, Physicians’ Services Incorporated.
The DASH and Constant-Murley are valid instruments for evaluating outcome in patients with a humeral shaft fracture. Reliability was only shown for the DASH, making this the preferred instrument. The observed MIC and SDC values provide a basis for sample size calculations for future research.
The proximal femoral nail (PFN) is a recently introduced intramedullary system, designed to improve treatment of unstable trochanteric fractures of the hip. In a multicentre prospective clinical study, the intra-operative use, complications and outcome of treatment using the PFN (n = 211) were compared with those using the gamma nail (GN) (n = 213). The intra-operative blood loss was lower with the PFN (220 ml v 287 ml, p = 0.001). Post-operatively, more lateral protrusion of the hip screws of the PFN (7.6%) was documented, compared with the gamma nail (1.6%, p = 0.02). Most local complications were related to suboptimal reduction of the fracture and/or positioning of the implant. Functional outcome and consolidation were equal for both implants. Generally, the results of treatment of unstable trochanteric fractures were comparable for the PFN and GN. The pitfalls and complications were similar, and mainly surgeon- or fracture-related, rather than implant-related.
Based on the results of this study our recommendation is to use a small fragment locking compression plate for open reduction and internal fixation of DMCF. The surgeon should always strive to fixate the plate on both sides of the fracture with at least three bicortical screws.
BackgroundFractures of the humeral shaft are associated with a profound temporary (and in the elderly sometimes even permanent) impairment of independence and quality of life. These fractures can be treated operatively or non-operatively, but the optimal tailored treatment is an unresolved problem. As no high-quality comparative randomized or observational studies are available, a recent Cochrane review concluded there is no evidence of sufficient scientific quality available to inform the decision to operate or not. Since randomized controlled trials for this injury have shown feasibility issues, this study is designed to provide the best achievable evidence to answer this unresolved problem. The primary aim of this study is to evaluate functional recovery after operative versus non-operative treatment in adult patients who sustained a humeral shaft fracture. Secondary aims include the effect of treatment on pain, complications, generic health-related quality of life, time to resumption of activities of daily living and work, and cost-effectiveness. The main hypothesis is that operative treatment will result in faster recovery.Methods/designThe design of the study will be a multicenter prospective observational study of 400 patients who have sustained a humeral shaft fracture, AO type 12A or 12B. Treatment decision (i.e., operative or non-operative) will be left to the discretion of the treating surgeon. Critical elements of treatment will be registered and outcome will be monitored at regular intervals over the subsequent 12 months. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand score. Secondary outcome measures are the Constant score, pain level at both sides, range of motion of the elbow and shoulder joint at both sides, radiographic healing, rate of complications and (secondary) interventions, health-related quality of life (Short-Form 36 and EuroQol-5D), time to resumption of ADL/work, and cost-effectiveness. Data will be analyzed using univariate and multivariable analyses (including mixed effects regression analysis). The cost-effectiveness analysis will be performed from a societal perspective.DiscussionSuccessful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture.Trial registrationThe trial is registered at the Netherlands Trial Register (NTR3617).
Ultrasonographic duplex scanning has become a valuable diagnostic technique in detecting and grading stenoses and occlusions of the aortoiliac and femoropopliteal arteries. However, the question remains as to whether a treatment strategy can be designed without diagnostic angiography. This prospective study evaluated the impact of duplex scanning on therapeutic decision making. Patients with intermittent claudication, rest pain or ischaemic ulceration of the lower limb who were eligible for invasive treatment were studied. If treatment was considered necessary, a duplex scan was performed instead of diagnostic angiography. The surgeon made a therapeutic decision based on clinical assessment and information obtained from the duplex scan. If it was felt that duplex scanning gave insufficient information, diagnostic angiography was then performed. A group of 112 consecutive patients were studied prospectively; 12 were excluded for logistical reasons. The 100 remaining patients (intermittent claudication in 69, rest pain in 16, ischaemic ulceration in 15) were evaluated. Based on non-invasive tests 22 patients were treated conservatively, 36 were scheduled for percutaneous transluminal angioplasty (PTA) and 32 were scheduled for surgery. Angiography was requested to determine the definitive treatment policy in 28 patients: four of the 22 were scheduled for conservative treatment and 24 of the 32 were scheduled for surgery. All PTAs were performed without prior diagnostic angiography. Angiography was considered necessary in a further ten patients to formulate a therapeutic strategy. In 62 patients the treatment strategy could be determined without diagnostic angiography. Twenty-three of the 39 angiograms performed did not give additional information on treatment strategy. Integrated use of duplex scanning for the investigation of patients with arterial occlusive disease of the lower limb can reduce the need for diagnostic angiography.
Purpose The best treatment of humeral shaft fractures in adults is still under debate. This study aimed to compare functional and clinical outcome of operative versus nonoperative treatment in adult patients with a humeral shaft fracture. We hypothesized that operative treatment would result in earlier functional recovery. Methods From October 23, 2012 to October 03, 2018, adults with a humeral shaft fracture AO type 12A or 12B were enrolled in a prospective cohort study in 29 hospitals. Patients were treated operatively or nonoperatively. Outcome measures were the Disabilities of the Arm, Shoulder, and Hand score (DASH; primary outcome), Constant–Murley score, pain (Visual Analog Score, VAS), health-related quality of life (Short Form-36 (SF-36) and EuroQoL-5D-3L (EQ-5D)), activity resumption (Numeric Rating Scale, NRS), range of motion (ROM) of the shoulder and elbow joint, radiologic healing, and complications. Patients were followed for one year. Repeated measure analysis was done with correction for age, gender, and fracture type. Results Of the 390 included patients, 245 underwent osteosynthesis and 145 were primarily treated nonoperatively. Patients in the operative group were younger (median 53 versus 62 years; p < 0.001) and less frequently female (54.3% versus 64.8%; p = 0.044). Superior results in favor of the operative group were noted until six months follow-up for the DASH, Constant–Murley, abduction, anteflexion, and external rotation of the shoulder, and flexion and extension of the elbow. The EQ-US, and pronation and supination showed superior results for the operative group until six weeks follow-up. Malalignment occurred only in the nonoperative group (N = 14; 9.7%). In 19 patients with implant-related complications (N = 26; 10.6%) the implant was exchanged or removed. Nonunion occurred more often in the nonoperative group (26.3% versus 10.10% in the operative group; p < 0.001). Conclusion Primary osteosynthesis of a humeral shaft fracture (AO type 12A and 12B) in adults is safe and superior to nonoperative treatment, and should therefore be the treatment of choice. It is associated with a more than twofold reduced risk of nonunion, earlier functional recovery and a better range of motion of the shoulder and elbow joint than nonoperative treatment. Even after including the implant-related complications, the overall rate of complications as well as secondary surgical interventions was highest in the nonoperative group. Trial registration NTR3617 (registration date 18-SEP-2012).
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