Cost-effectiveness of on-demand removal of syndesmotic screws.

PURPOSE: Syndesmotic screw removal following acute syndesmotic injury is a commonly performed procedure. However, recent studies suggest that the removal does not result in improved patient reported outcome, while the procedure has proved not to be without complications. The aim of this study was to present a health-economic evaluation of on-demand removal (ODR) compared to routine removal (RR) of the syndesmotic screw. METHODS: Data were collected from the RODEO trial, a randomized controlled non-inferiority trial comparing functional outcome of ODR with RR. Economic evaluation resulted in total costs, costs (in Euro) per quality adjusted life year (QALY) and costs per point improvement on the Olerud Molander Ankle Score (OMAS). This included both direct and indirect costs. RESULTS: Total costs for ODR were significantly lower with a mean difference of 3160 euro compared to RR (p < 0.001). The difference in QALY was not significant. The difference in OMAS at 12 months was 1.79 with an incremental cost-effectiveness ratio (ICER) of €-1763 (p = 0.512). The ICER was well below the willingness to pay. Although unit costs might vary between hospitals and countries, these results provide relevant data of cost-effectiveness. CONCLUSION: The clinical effectiveness of both ODR and RR can be considered equal. The costs are lower for patients treated with ODR, which leads to the conclusion that ODR is cost-effective.

Correction to: Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial).

An amendment to this paper has been published and can be accessed via the original article.

Functional Outcomes after Corrective Osteotomy of Symptomatic Distal Radius Malunions in Children.

Background Closed reduction and cast immobilization of displaced distal radius fractures carries the risk of secondary displacement, which could result in a symptomatic malunion. In patients with a symptomatic malunion, a corrective osteotomy can be performed to improve pain and functional impairment of the wrist joint. Objective The aim of this study was to assess the functional outcomes of children who underwent a corrective osteotomy due to a symptomatic malunion of the distal radius. Methods Between 2009 and 2016, all consecutive corrective osteotomies of the distal radius of patients younger than 18 years were reviewed. The primary outcome was functional outcome assessed with the ABILHAND-Kids score. Secondary outcomes were QuickDASH (Quick Disabilities of Arm, Shoulder, and Hand) score, range of motion, complications, and radiological outcomes. Results A total of 13 patients with a median age of 13 years (interquartile range [IQR]: 12.5-16) were included. The median time to follow-up was 31 months (IQR: 26-51). The median ABILHAND-Kids score was 42 (range: 37-42), and the median QuickDASH was 0 (range: 0-39). Range of motion did not differ significantly between the injured and the uninjured sides for all parameters. One patient had a nonunion requiring additional operative treatment. The postoperative radiological parameters showed an improvement of radial inclination, radial height, ulnar variance, dorsal tilt, and dorsal tilt. Conclusion Corrective osteotomy for children is an effective method for treating symptomatic malunions of the distal radius. Level of Evidence This is a Level IV study.

Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial).

BACKGROUND: Syndesmotic injuries are common and their incidence is rising. In case of surgical fixation of the syndesmosis a metal syndesmotic screw is used most often. It is however unclear whether this screw needs to be removed routinely after the syndesmosis has healed. Traditionally the screw is removed after six to 12 weeks as it is thought to hamper ankle functional and to be a source of pain. Some studies however suggest this is only the case in a minority of patients. We therefore aim to investigate the effect of retaining the syndesmotic screw on functional outcome. DESIGN: This is a pragmatic international multicentre randomised controlled trial in patients with an acute syndesmotic injury for which a metallic syndesmotic screw was placed. Patients will be randomised to either routine removal of the syndesmotic screw or removal on demand. Primary outcome is functional recovery at 12 months measured with the Olerud-Molander Score. Secondary outcomes are quality of life, pain and costs. In total 194 patients will be needed to demonstrate non-inferiority between the two interventions at 80% power and a significance level of 0.025 including 15% loss to follow-up. DISCUSSION: If removal on demand of the syndesmotic screw is non-inferior to routine removal in terms of functional outcome, this will offer a strong argument to adopt this as standard practice of care. This means that patients will not have to undergo a secondary procedure, leading to less complications and subsequent lower costs. TRIAL REGISTRATION: This study was registered at the Netherlands Trial Register (NTR5965), Clinicaltrials.gov ( NCT02896998 ) on July 15th 2016.

Factors affecting the rate of surgical site infection in patients after hemiarthroplasty of the hip following a fracture of the neck of the femur.

AIMS: Surgical site infection can be a devastating complication of hemiarthroplasty of the hip, when performed in elderly patients with a displaced fracture of the femoral neck. It results in a prolonged stay in hospital, a poor outcome and increased costs. Many studies have identified risk and prognostic factors for deep infection. However, most have combined the rates of infection following total hip arthroplasty and internal fixation as well as hemiarthroplasty, despite the fact that they are different entities. The aim of this study was to clarify the risk and prognostic factors causing deep infection after hemiarthroplasty alone. PATIENTS AND METHODS: Data were extracted from a prospective hip fracture database and completed by retrospective review of the hospital records. A total of 916 patients undergoing a hemiarthroplasty in two level II trauma teaching hospitals between 01 January 2011 and 01 May 2016 were included. We analysed the potential peri-operative risk factors with univariable and multivariable logistic regression analysis. RESULTS: A total of 92 patients (10%) had a surgical site infection, and 44 (4.9%) developed a deep infection. After univariable analyses, the multivariable model showed that the level of experience of the surgeon measured by the number of hemiarthroplasties performed per year was a significant prognostic factor (odds ratio (OR) 0.93, p = 0.042) for the development of an infection. Secondly, the development of a haematoma (OR 9.6, p < 0.001), a re-operation (OR 4.7, p = 0.004) and an operating time of < 45 mins (OR 5.1, p = 0.002) or > 90 mins (OR 2.7, p = 0.034) were also significant factors. CONCLUSION: There was a significant association between the experience of the surgeon and the rate of deep infection. Secondly, a haematoma, a re-operation and both shorter and longer operating times were associated with an increased risk of deep infection after hemiarthroplasty. No association was found between deep infection and the anatomical approach, the time when surgery was undertaken and the use of a drain. Cite this article: Bone Joint J 2017;99-B:1088-94.

Internal Fixation Versus Hemiarthroplasty for Displaced Intra-Capsular Femoral Neck Fractures in ASA 3-5 Geriatric Patients.

BACKGROUND: The treatment of choice for elderly with a displaced intra-capsular femoral neck fractures is prosthetic replacement. This is however a major surgical procedure for geriatric patients with multiple co-morbidities which can threaten hemodynamic stability and lead to death. In this study we compared the outcome of internal fixation (IF) versus hemiarthroplasty (HA) for the management of intra-capsular femoral neck fractures in the elderly with severe co-morbidities. METHODS: We conducted a retrospective cohort study of all the patients who were admitted to our Level-II trauma centre with a femoral neck fracture between January 2009 and June 2011. Inclusion criteria were: 70 years or older, ASA 3 or higher, a displaced femoral neck fracture and treatment with either internal fixation or a cemented hemiprosthesis. The primary outcome was 6-month mortality rate. Secondary outcomes were 30-day mortality, post-operative complications, re-operation rate and length of hospital stay. RESULTS: 80 patients met our inclusion criteria. The mean age of the IF group was 81.6 years and in the HA group it was 84.5 years (P=0.07). The medical records were retrieved 34-64 months after surgery. Two intra-operative deaths due to cement implantation syndrome were found in the HA group and none in the IF group. Twelve patients (21.8%) in the HA group died within 30 days after surgery and 2 (8.0%) in the IF group (P=0.21). The mean operating time was 83 min. for the HA group and 51 min. for the IF group (P=0.000). There were more implant-related complications in the IF than in the HA group (36% vs 9.1% respectively, P=0.008). The 6-month mortality rates didn't differ between the IF and the HA groups (respectively 28.0% vs 34.5%, P=0.62). CONCLUSION: The post-operative mortality rates did not differ between the IF and the HA groups in elderly patients with a displaced femoral neck fracture and ASA 3 to 5. However, the HA associated with less implant-related complications than the IF in this group and it is therefore the treatment of choice.

The reliability of a simplified Garden classification for intracapsular hip fractures.

BACKGROUND: The Garden classification is used to classify intracapsular proximal femur fractures. The reliability of this classification is poor and several authors advise a simplified classification of intracapsular hip fractures into non-displaced and displaced fractures. However, this proposed simplified classification has never been tested for its reliability. HYPOTHESIS: We estimate simplifying the classification of femoral neck fractures will lead to a higher inter-observer agreement. MATERIALS AND METHODS: Ten observers, trauma surgeons and residents, from two different institutes classified 100 intracapsular femoral neck fractures. The inter-observer agreements were calculated using the multi-rater Fleiss' kappa. RESULTS: The inter-observer kappa for the Garden classification was 0.31. An agreement of κ0.52 was observed if the Garden classification was simplified and the fractures were classified by our observers as 'non-displaced' or 'displaced'. No difference in reliability was seen for the use of the four-grade Garden classification as well as the simplified classification between trauma surgeons and residents. DISCUSSION: Classification of intracapsular hip fractures according to the four-grade Garden classification is unreliable. The reliability of classification improves when the Garden classification is simplified in a classification using the terms: 'non-displaced' or 'displaced'. LEVEL OF EVIDENCE: Level IV. Diagnostic retrospective study.

The Pauwels classification for intracapsular hip fractures: is it reliable?

The Pauwels classification for the femoral neck fracture is still broadly used in literature and clinical practise. However, this classification has never been tested for its reliability in terms of inter-observer agreement. We assessed whether or not it is reliable to use the Pauwels classification in pre-operative planning. Ten observers classified 100 intra-capsular femur fractures. The inter-observer agreement was calculated using the multi-rater Fleiss' kappa. The Pauwels classification showed an inter-observer agreement of κ0.31 (0.01). Classification of intra-capsular hip fractures according to the Pauwels classification using the Pauwels angle is unreliable and its use should be avoided.

The comparison of two classifications for trochanteric femur fractures: the AO/ASIF classification and the Jensen classification.

This study compares the reproducibility of two classifications for trochanteric femur fractures: the Jensen classification and the AO/ASIF classification. Furthermore we evaluated the agreement on fracture stability, choice of osteosynthesis, fracture reduction and the accuracy of implant positioning. In order to calculate the inter-, and intra-observer variability 10 observers classified 50 trochanteric fractures. The inter-observer agreement of the AO/ASIF classification and the Jensen classification was kappa0.40 and kappa0.48. The kappa coefficient of the intra-observer reliability of the AO/ASIF classification was kappa0.43 and kappa0.56 for the Jensen classification. Preoperative agreement on fracture stability and type of implant showed kappa values of kappa0.39 and kappa0.65. The postoperative agreement on choice of implant, fracture reduction and position of the implant was kappa0.17, kappa0.29 and kappa0.22, respectively. Both classifications showed poor reproducibility. This study suggests that the definition of stability of trochanteric fractures remains controversial, which possibly complicates the choice of osteosynthesis.

The clavicle hook plate for Neer type II lateral clavicle fractures.

OBJECTIVE: To evaluate functional and radiologic outcome in patients with a Neer type II lateral clavicle fracture treated with the clavicle hook plate. DESIGN: Multicenter retrospective study. SETTING: Five level I and II trauma centers. PATIENTS: Forty-four patients, average age 38.4 years (18-66 years), with a Neer type II lateral clavicle fracture treated with the clavicle hook plate between January 1, 2003, and December 31, 2006. INTERVENTION: Open reduction and internal fixation with the clavicle hook plate. Removal of all 44 implants after consolidation at a mean of 8.4 months (2-33 months) postoperatively. MAIN OUTCOME MEASUREMENTS: At an average follow-up of 27.4 months (13-48 months), functional outcome was assessed with the Constant-Murley scoring system. Radiographs were taken to evaluate consolidation and to determine the distance between the coracoid process and the clavicle. RESULTS: The average Constant score was 92.4 (74-100). The average distance between the coracoid process and the clavicle was 9.8 mm (7.3-14.8 mm) compared with 9.4 mm (6.9-14.3 mm) on the contralateral nonoperative side. We observed 1 dislocation of an implant (2.2%), 2 cases of pseudarthrosis (4.5%), 2 superficial wound infections (4.5%), 2 patients with hypertrophic scar tissue (4.5%), and 3 times an acromial osteolysis (6.8%). Thirty patients (68%) reported discomfort due to the implant. These implant-related complaints and the acromial osteolysis disappeared after removal of the hook plate. With all the patients, direct functional aftercare was possible. CONCLUSIONS: The clavicle hook plate is a suitable implant for Neer type II clavicle fractures. The advantage of this osteosynthesis is the possibility of immediate functional aftercare. We observed a high percentage of discomfort due to the implant; therefore, we advise to remove the implant as soon as consolidation has taken place.

Effect of exercise-induced ischemia on QT interval dispersion.

An increased spatial dispersion of ventricular repolarization duration (QT dispersion) is associated with an increased vulnerability to arrhythmias. This study was designed to examine the effect of exercise on QT dispersion in ischemic heart disease (IHD). QT dispersion, corrected QT dispersion, and percentage change in uncorrected and corrected QT dispersion between rest and peak exercise were examined in 14 members of a control group, 17 patients with IHD, and 14 patients with IHD who were receiving beta-blockers (IHD-B). All subjects had undergone a standard Bruce protocol exercise test, and QT intervals were measured at rest and peak exercise with a digitizing tablet interfaced to a personal computer. QT dispersion at rest was markedly increased in the IHD group compared with that in the control and IHD-B groups, respectively (corrected QT dispersion in milliseconds), 74 +/- 7, 40 +/- 4, 49 +/- 5, p < 0.03). The corrected QT dispersion at peak exercise was greater in the IHD group compared with that in the control group (57 +/- 5 vs 26 +/- 3 msec, p < 0.03). The percentage change in QT dispersion with exercise was significantly higher in the IHD group (52% +/- 5%) compared with that in both the control group (28% +/- 4%, p < 0.002) and the IHD-B group (30% +/- 3%, p < 0.01). A larger mean QT dispersion at peak exercise and an increased percentage change in QT dispersion with exercise may help explain the increased susceptibility of the IHD group for arrhythmias. The cardioprotective action of beta-blockers may be explained by their blunting effect on exercise-related changes in QT dispersion.

Location of external anal sphincter motoneurons in the sacral cord of the female domestic pig.

The location of the striated external anal sphincter motoneurons in the spinal cord was investigated in 12, between 3 and 4 months old, female domestic pigs using the retrograde tracer horseradish peroxidase (HRP). Their motoneuronal cell bodies were found in the spinal segments S1-S3, and were not located in the ventral horn, but dorsolateral to the central canal. This location within the spinal gray matter strongly differs from the location of the external and sphincter motoneurons in rat, cat, dog, monkey and humans, but is similar to that in the Mongolian gerbil. The possible relevance of this 'aberrant' location is discussed.