What Factors Are Associated With Implant Breakage and Revision After Intramedullary Nailing for Femoral Metastases?

BACKGROUND: Actual and impending pathologic fractures of the femur are commonly treated with intramedullary nails because they provide immediate stabilization with a minimally invasive procedure and enable direct weightbearing. However, complications and revision surgery are prevalent, and despite common use, there is limited evidence identifying those factors that are associated with complications. QUESTIONS/PURPOSES: Among patients treated with intramedullary nailing for femoral metastases, we asked the following questions: (1) What is the cumulative incidence of local complications? (2) What is the cumulative incidence of implant breakage and what factors are associated with implant breakage? (3) What is the cumulative incidence of revision surgery and what factors are associated with revision surgery? METHODS: Between January 2000 and December 2015, 245 patients in five centers were treated with intramedullary nails for actual and impending pathologic fractures of the femur caused by bone metastases. During that period, the general indications for intramedullary nailing of femoral metastases were impending fractures of the trochanter region and shaft and actual fractures of the trochanter region if sufficient bone stock remained; nails were used for lesions of the femoral shaft if they were large or if multiple lesions were present. Of those treated with intramedullary nails, 51% (117) were actual fractures and 49% (111) were impending fractures. A total of 60% (128) of this group were women; the mean age was 65 years (range, 29-93 years). After radiologic followup (at 4-8 weeks) with the orthopaedic surgeon, because of the palliative nature of these treatments, subsequent in-person followup was performed by the primary care provider on an as-needed basis (that is, as desired by the patient, without any scheduled visits with the orthopaedic surgeon) throughout each patient's remaining lifetime. However, there was close collaboration between the primary care providers and the orthopaedic team such that orthopaedic complications would be reported. A total of 67% (142 of 212) of the patients died before 1 year, and followup ranged from 0.1 to 175 months (mean, 14.4 months). Competing risk models were used to estimate the cumulative incidence of local complications (including persisting pain, tumor progression, and implant breakage), implant breakage separately, and revision surgery (defined as any reoperation involving the implant other than débridement with implant retention for infection). A cause-specific multivariate Cox regression model was used to estimate the association of factors (fracture type/preoperative radiotherapy and fracture type/use of cement) with implant breakage and revision, respectively. RESULTS: Local complications occurred in 12% (28 of 228) of the patients and 6-month cumulative incidence was 8% (95% confidence interval [CI], 4.7-11.9). Implant breakage occurred in 8% (18 of 228) of the patients and 6-month cumulative incidence was 4% (95% CI, 1.4-6.5). Independent factors associated with increased risk of implant breakage were an actual (as opposed to impending) fracture (cause-specific hazard ratio [HR_cs], 3.61; 95% CI, 1.23-10.53, p = 0.019) and previous radiotherapy (HR_cs, 2.97; 95% CI, 1.13-7.82, p = 0.027). Revisions occurred in 5% (12 of 228) of the patients and 6-month cumulative incidence was 2.2% (95% CI, 0.3-4.1). The presence of an actual fracture was independently associated with a higher risk of revision (HR_cs, 4.17; 95% CI, 0.08-0.82, p = 0.022), and use of cement was independently associated with a lower risk of revision (HR_cs, 0.25; 95% CI, 1.20-14.53, p = 0.025). CONCLUSIONS: The cumulative incidence of local complications, implant breakage, and revisions is low, mostly as a result of the short survival of patients. Based on these results, surgeons should consider use of cement in patients with intramedullary nails with actual fractures and closer followup of patients after actual fractures and preoperative radiotherapy. Future, prospective studies should further analyze the effects of adjuvant therapies and surgery-related factors on the risk of implant breakage and revisions. LEVEL OF EVIDENCE: Level III, therapeutic study.

High Irritation and Removal Rates After Plate or Nail Fixation in Patients With Displaced Midshaft Clavicle Fractures.

BACKGROUND: Studies comparing plate with intramedullary nail fixation of displaced midshaft clavicle fractures show faster recovery in the plate group and implant-related complications in both groups after short-term followup (6 or 12 months). Knowledge of disability, complications, and removal rates beyond the first postoperative year will help surgeons in making a decision regarding optimal implant choice. However, comparative studies with followup beyond the first year or two are scarce. QUESTIONS/PURPOSES: We asked: (1) Does plate fixation or intramedullary nail fixation for displaced midshaft clavicle fractures result in less disability? (2) Which type of fixation, plate or intramedullary, is more frequently associated with implant-related irritation and implant removal? (3) Is plate or intramedullary fixation associated with postoperative complications beyond the first postoperative year? METHODS: Between January 2011 and August 2012, patients with displaced midshaft clavicle fractures were enrolled and randomized to plate or intramedullary nail fixation. A total of 58 patients with plate and 62 patients with intramedullary nails initially were enrolled. Minimum followup was 30 months (mean, 39 months; range, 30-51 months). Two patients (3%) with plate fixation and two patients (3%) with intramedullary nails were lost to followup. The QuickDASH was obtained at final followup and compared between patients who had plate fixation and those who had intramedullary nail fixation. Postoperative complications measured include infection, implant-related irritation, implant failure, nonunion, and refracture after implant removal. Indications for implant removal included implant-related irritation, implant failure, nonunion, patient's wish, or surgeon's preference. RESULTS: Between patients with plate versus intramedullary nail fixation, there were no differences in QuickDASH scores (plate, 1.8 ± 3.6; intramedullary nail, 1.8 ± 7.2; mean difference, -0.7; 95% CI, -2.2 to 2.04; p = 0.95). The proportion of patients having implant-related irritation was not different (39 of 56 [70%] versus 41 of 62 [66%]; relative risk, 1.05; 95% CI, 0.82-1.35; p = 0.683). Intramedullary fixation was associated with a higher likelihood of implant removal (51 of 62 [82%] versus 28 of 56 [50%]; relative risk, 1.65; 95% CI, 1.24-2.19; p < 0.001). Among the removed implants more plates than intramedullary nails were removed after the 1-year followup (12 of 28 [43%] versus six of 51 [12%]; p = 0.002). There were no infections, implant breakage, nonunions, or refractures between the 1-year and final followup in either group. CONCLUSIONS: After a mean followup of 39 months, disability scores were excellent. Major complications did not occur after the 1-year followup. A frequent and bothersome problem after both surgical treatments is implant-related irritation, resulting in high rates of implant removal, after 1 year. Future research could focus on analyzing risk factors for implant irritation or removal. LEVEL OF EVIDENCE: Level II, therapeutic study.

A randomized controlled trial of nonoperative treatment versus open reduction and internal fixation for stable, displaced, partial articular fractures of the radial head: the RAMBO trial.

BACKGROUND: The choice between operative or nonoperative treatment is questioned for partial articular fractures of the radial head that have at least 2 millimeters of articular step-off on at least one radiograph (defined as displaced), but less than 2 millimeter of gap between the fragments (defined as stable) and that are not associated with an elbow dislocation, interosseous ligament injury, or other fractures. These kinds of fractures are often classified as Mason type-2 fractures. Retrospective comparative studies suggest that operative treatment might be better than nonoperative treatment, but the long-term results of nonoperative treatment are very good. Most experts agree that problems like reduced range of motion, painful crepitation, nonunion or bony ankylosis are infrequent with both nonoperative and operative treatment of an isolated displaced partial articular fracture of the radial head, but determining which patients will have problems is difficult. A prospective, randomized comparison would help minimize bias and determine the balance between operative and nonoperative risks and benefits. METHODS/DESIGN: The RAMBO trial (Radial Head - Amsterdam - Amphia - Boston - Others) is an international prospective, randomized, multicenter trial. The primary objective of this study is to compare patient related outcome defined by the 'Disabilities of Arm, Shoulder and Hand (DASH) score' twelve months after injury between operative and nonoperative treated patients. Adult patients with partial articular fractures of the radial head that comprise at least 1/3rd of the articular surface, have ≥ 2 millimeters of articular step-off but less than 2 millimeter of gap between the fragments will be enrolled. Secondary outcome measures will be the Mayo Elbow Performance Index (MEPI), the Oxford Elbow Score (OES), pain intensity through the 'Numeric Rating Scale', range of motion (flexion arc and rotational arc), radiographic appearance of the fracture (heterotopic ossification, radiocapitellar and ulnohumeral arthrosis, fracture healing, and signs of implant loosening or breakage) and adverse events (infection, nerve injury, secondary interventions) after one year. DISCUSSION: The successful completion of this trial will provide evidence on the best treatment for stable, displaced, partial articular fractures of the radial head. TRIAL REGISTRATION: The trial is registered at the Dutch Trial Register: NTR3413.

HUMeral shaft fractures: measuring recovery after operative versus non-operative treatment (HUMMER): a multicenter comparative observational study.

BACKGROUND: Fractures 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/DESIGN: The 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. DISCUSSION: Successful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register (NTR3617).

The relation between surgical approaches for pelvic ring and acetabular fractures and postoperative complications: a systematic review.

INTRODUCTION: Although many articles report complications after pelvic ring and acetabular fracture surgery, a general overview of complication rates and potential risk factors is lacking. The current review provides a comprehensive summary of the complications after pelvic ring and acetabular fracture surgery in relation to the surgical approach. MATERIAL AND METHODS: Pubmed and Embase databases were systematically searched using the key words: pelvic fracture, acetabular fracture, fixation, surgical approaches, complications, and their synonyms. Extracted data included patient and fracture characteristics, surgical approaches, and post-operative complications; surgical site infections (SSI), implant-related complications, malunion and non-union. Study data were summarized using descriptive statistics. RESULTS: Twenty-two studies (twenty-one retrospective cohort studies, of which three comparative, and one randomized controlled trial) were included in this review. The overall complication rates reported for the included surgical approaches were: 17% for the (Modified) Stoppa approach, 11% for percutaneous fixation, 5% for the Kocher-Langenbeck approach, 7% for the ilioinguinal approach and 31% for external fixation. The most frequent complications were SSI (22%) and neurological (31%) complications, which were most often reported in patients treated with an external fixator. Re-operation rates were comparable for the surgical approaches (4-8%). Two studies reported on risk factors and identified concomitant traumatic injuries, prolonged ICU stay and high body mass index as risk factors for SSI. CONCLUSION: External fixation of pelvic fractures is associated with highest complications rates including SSI's and neurological complications. Although post-operative complications are frequently reported after pelvic fracture surgery, more studies are needed that identify potential risk factors. These will assist the surgeon in (pre)operative decision making and development of preventive strategies.

Mortality decreases by implementing a level I trauma center in a Dutch hospital.

BACKGROUND: Trauma centers are designed to improve survival and outcome of the injured patient. The implementation of these centers in the United States has shown to reduce the number of preventable deaths from serious injuries. This study compares outcomes of trauma patients during two separate time periods in a Dutch Level I trauma center, before and after obtaining the trauma center status. METHODS: Prospectively, patient data were collected from an automated database in the years 1996 through 1998 (period 1) and 2003 through 2005 (period 2) in the University Medical Center in Utrecht. The patients included and analyzed were adult trauma victims admitted to our trauma center. RESULTS: A total of 4,069 patients in total were included, 2,348 in period 1 and 1,721 in period 2. Mean age was 45.9 years and 48.1 years, respectively (p < 0.001). Men comprised 62% and 64%, respectively (not significant). After obtaining the trauma center status, more severely injured patients were admitted (mean Injury Severity Score was 9.6 in group 1 vs. 12.4 in group 2, p < 0.001). Adjusted for age and injury severity, the inhospital mortality was lower (odds ratio: 0.606, p < 0.05) in the second group. Adjusted for age, Injury Severity Score, and mortality, the hospital stay was shorter (p < 0.001) in the second group. Fewer patients were admitted to the intensive care unit (p < 0.001), but the length of stay appeared longer (p = 0.055) after trauma center designation. CONCLUSION: This study implies that the implementation of a trauma center reduces mortality, shortens hospital stay, and decreases the number of intensive care unit admittances in Utrecht, the Netherlands.

Functional treatment versus plaster for simple elbow dislocations (FuncSiE): a randomized trial.

BACKGROUND: Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures. After reduction of a simple dislocation, treatment options include immobilization in a static plaster for different periods of time or so-called functional treatment. Functional treatment is characterized by early active motion within the limits of pain with or without the use of a sling or hinged brace. Theoretically, functional treatment should prevent stiffness without introducing increased joint instability. The primary aim of this randomized controlled trial is to compare early functional treatment versus plaster immobilization following simple dislocations of the elbow. METHODS/DESIGN: The design of the study will be a multicenter randomized controlled trial of 100 patients who have sustained a simple elbow dislocation. After reduction of the dislocation, patients are randomized between a pressure bandage for 5-7 days and early functional treatment or a plaster in 90 degrees flexion, neutral position for pro-supination for a period of three weeks. In the functional group, treatment is started with early active motion within the limits of pain. Function, pain, and radiographic recovery will be evaluated at regular intervals over the subsequent 12 months. The primary outcome measure is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford elbow score, pain level at both sides, range of motion of the elbow joint at both sides, rate of secondary interventions and complication rates in both groups (secondary dislocation, instability, relaxation), health-related quality of life (Short-Form 36 and EuroQol-5D), radiographic appearance of the elbow joint (degenerative changes and heterotopic ossifications), costs, and cost-effectiveness. DISCUSSION: The successful completion of this trial will provide evidence on the effectiveness of a functional treatment for the management of simple elbow dislocations. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register (NTR2025).

The impact of medical specialist staffing on emergency department patient flow and satisfaction.

OBJECTIVE: The aim of this study was to describe the impact of additional medical specialists, non-emergency physicians (non-EPs), performing direct supervision or a combination of direct and indirect supervision at an EP-led emergency department (ED), on patient flow and satisfaction. PATIENTS AND METHODS: An observational, cross-sectional, three-part study was carried out including staff surveys (n=379), a before and after 16-week data collection using data of visits during the peak hours (n=5270), and patient questionnaires during 1 week before the pilot and during week 5 of the pilot. Content analysis and descriptive statistics were used for analyses. RESULTS: The value of being present at the ED was acknowledged by medical specialists in 49% of their surveys and 35% of the EPs' and ED nurses' surveys, especially during busy shifts. Radiologists were most often (67.3%) convinced of their value of being on-site, which was agreed upon by the ED professionals. Perceived improved quality of care, shortening of length of stay, and enhanced peer consultation were mentioned most often.During the pilot period, length of stay of boarded patients decreased from 197 min (interquartile range: 121 min) to 181 min (interquartile range: 113 min, P=0.006), and patient recommendation scores increased from -15 to +20. CONCLUSION: Although limited by the mix of direct and indirect supervision, our results suggest a positive impact of additional medical specialists during busy shifts. Throughput of admitted patients and patient satisfaction improved during the pilot period. Whether these findings differ between direct supervision and combination of direct and indirect supervision by the medical specialists requires further investigation.

Shared decision making in the management of midshaft clavicular fractures: Nonoperative treatment or plate fixation.

INTRODUCTION: Most patients with a displaced midshaft clavicular fracture can be treated either operatively or nonoperatively, with similar long-term outcomes. The treatment choice depends on individual preferences, and is therefore suited for a shared decision making (SDM) approach. However, little is known about SDM in fracture treatment. The purpose of this study was to evaluate the current daily practice of shared decisional behaviour in clavicular fracture treatment, in order to assess the need for improvement and set a baseline level for future research. PATIENTS AND METHODS: All consecutive adult patients treated in two hospitals for a displaced, midshaft clavicular fracture in 2015 filled out a questionnaire shortly after the decision making moment, that consisted of questions concerning their knowledge and preferences regarding the treatment options; the SDM-Q-9-NL to measure the perceived degree of SDM, and the Control Preferences Scale to measure patients' preferred and actual roles in decision making. RESULTS: Fifty patients were included. Eighteen percent of the patients were unaware of the treatment options before the consultation, 48% had no preference for either treatment option. The mean score for perceived degree of SDM was 74 out of 100 (SD 23, range 12.5-100). In 68% of patients, the preferred role matched the actual role in making the decision. Sixteen patients (32%) would have preferred either a less (n=8) or a more (n=8) active role. CONCLUSION: The patient-reported level of SDM in treatment decisions for clavicular fractures was high, but not all patients had the role in this process that they preferred. To improve patients' involvement in the treatment decision making process for clavicular fractures, it is important to create general awareness about SDM, and increase knowledge of orthopaedic trauma surgeons about SDM behaviour.

Operative treatment of dislocated midshaft clavicular fractures: plate or intramedullary nail fixation? A randomized controlled trial.

BACKGROUND: Over the past decades, the operative treatment of displaced midshaft clavicular fractures has increased. The aim of this study was to compare short and midterm results of open reduction and plate fixation with those of intramedullary nailing for displaced midshaft clavicular fractures. METHODS: A multicenter, randomized controlled trial was performed in four different hospitals. The study included 120 patients, eighteen to sixty-five years of age, treated with either open reduction and plate fixation (n = 58) or intramedullary nailing (n = 62). Preoperative and postoperative shoulder function scores and complications were documented until one year postoperatively. Significance was set at p < 0.05. RESULTS: No significant differences in the Disabilities of the Arm, Shoulder and Hand (DASH) or Constant-Murley score (3.0 and 96.0 points for the plate group and 5.6 and 95.5 points for the nailing group) were noted between the two surgical interventions at six months postoperatively. Until six months after the surgery, the plate-fixation group experienced less disability than the nailing group as indicated by the area under the curve of the DASH scores for this time period (p = 0.02). The mean numbers of complications per patient, irrespective of their severity, were similar between the plate-fixation (0.67) and nailing (0.74) groups (p = 0.65). CONCLUSIONS: The patients in the plate-fixation group recovered faster than the patients in the intramedullary nailing group, but the groups had similar results at six months postoperatively and the time of final follow-up. The rate of complications requiring revision surgery was low. Implant-related complications occurred frequently and could often be treated by implant removal.

[Splenic rupture days after falling: coordination by the surgeon]. / Miltruptuur dagen na val: de chirurg coördineert.

Delayed presentation of blunt abdominal trauma requires a specific work-up and treatment. Patients who present several days after blunt trauma are haemodynamically stable and therefore do not require standard Advanced Trauma Life Support (ATLS) management. These patients require a unique approach by a dedicated team to evaluate and treat possible occult injuries. In line with this, ultrasound alone is not sufficient and retroperitoneal evaluation by means of contrast-enhanced abdominal CT to rule out occult injuries is necessary. A delayed occult splenic injury, as presented here, requires angiography only if there are signs on CT that predict an increased risk of delayed rupture. In addition, hospitalisation of these patients is not always necessary.

Rationale and design of the plate or pin (POP) study for dislocated midshaft clavicular fractures: study protocol for a randomised controlled trial.

BACKGROUND: To describe the rationale and design of a future study comparing results of plate fixation and Elastic Stable Intramedullary Nailing (ESIN) with a Titanium Elastic Nail (TEN) for adults with a dislocated midshaft clavicular fracture. METHODS/DESIGN: Prospective randomized multicenter clinical trial in two level 1 and one level 2 trauma centers. 120 patients between 18 and 65 years of age will be included. They are randomized to either plate fixation or ESIN with a TEN with a one year follow-up. Sixty patients will be treated with plate fixation and 60 patients will be treated with ESIN. Primary outcome parameter is the Disabilities of the Arm, Shoulder and Hand score after 6 months. Secondary outcome parameters are Constant Shoulder Score, complications, experienced pain, radiologic consolidation and cosmetics after both procedures. DISCUSSION: Prospective randomized studies comparing operative techniques for treatment of dislocated midshaft clavicular fracture are lacking. By studying shoulder function, complications, quality of life, radiographic union, cosmetics as well as experienced pain, a complete efficacy assessment of both procedures will be performed. TRIAL REGISTRATION: The POP study is registered in the Dutch Trial Register (NTR NTR2438).

Early computed tomography compared with bone scintigraphy in suspected scaphoid fractures.

PURPOSE: This study examined whether multidetector computed tomography (CT) is superior to bone scintigraphy for diagnosis of an occult scaphoid fracture. METHODS AND MATERIALS: In a study period of 22 months, 100 consecutive patients with a clinically suspected scaphoid fracture and no fracture on scaphoid radiographs, were evaluated with CT within 24 hours after injury and bone scintigraphy between 3 and 5 days after injury. The reference standard for a true (radiographic occult) scaphoid fracture was either (1) diagnosis of fracture on both CT and bone scintigraphy or (2) in case of discrepancy, clinical and/or radiographic evidence of a fracture during follow-up. RESULTS: CT showed 10 scaphoid and 18 other fractures. Bone scintigraphy showed 21 scaphoid and 36 other fractures. According to the reference standard, there were 14 scaphoid fractures. CT had a sensitivity of 64%, specificity of 99%, accuracy of 94%, a positive predictive value of 90%, and a negative predictive value of 94%. Bone scintigraphy had a sensitivity of 93%, specificity of 91%, accuracy of 91%, a positive predictive value of 62%, and a negative predictive value of 99%. CONCLUSION: This study could not confirm that early CT imaging is superior to bone scintigraphy for suspected scaphoid fractures.

Non-operative treatment of non-displaced scaphoid fractures may be preferred.

AIM: To evaluate the outcome of non-displaced scaphoid fractures treated with 6 weeks of cast immobilisation, and to establish whether the benefits of non-operative treatment might outweigh those of early operation. METHODS: A retrospective study analysed 89 consecutive cases of scaphoid fracture treated at our institution between 2004 and 2007. Diagnosis and treatment methods and complication rates were evaluated. RESULTS: Among 71 non-displaced scaphoid fractures, >80% showed clinical consolidation after 6 weeks of cast immobilisation, and the remaining cases after 8-12 weeks. Two cases needed a longer period of cast immobilisation. CONCLUSION: A restricted period of cast immobilisation is usually adequate for the treatment of non-displaced scaphoid fractures.