Dansyl Emits from a PICT Excited State.

Two derivatives of dansyl (1-dimethylamino-5-naphthalenesulfonyl) in which the amino group is constrained in a ring are prepared as neopentyl esters. Their photophysical behavior is compared with that of the dansyl ester. The solvatochromism and quantum yields are similar for all three. Since the two constrained derivatives cannot twist about the amino group, they must emit from a planar intramolecular charge-transfer excited state. The similar photophysical behavior suggests that dansyl also emits from a PICT excited state instead of a twisted intramolecular charge transfer state.

Implant Removal After Internal Fixation of a Femoral Neck Fracture: Effects on Physical Functioning.

OBJECTIVES: The effect of implant removal after internal fixation of a femoral neck fracture on physical functioning was analyzed. Characteristics of patients who had their implant removed were studied, as it is currently unknown from which type of patients implants are removed and what effect removal has on function. DESIGN: Secondary cohort study alongside a randomized controlled trial. SETTING: Multicenter study in 14 hospitals. PATIENTS AND INTERVENTION: Patients who had their implant removed after internal fixation of a femoral neck fracture are compared with patients who did not. MAIN OUTCOME MEASUREMENTS: Patient characteristics and quality of life (Short Form 12, Western Ontario McMaster Osteoarthritis Index) were compared. Matched pairs were selected based on patient/fracture characteristics and prefracture physical functioning. RESULTS: Of 162 patients, 37 (23%) had their implant removed. These patients were younger (median age: 67 vs. 72 years, P = 0.024) and more often independently ambulatory prefracture (100% vs. 84%, P = 0.008) than patients who did not. They more often had evident implant back-out on x-rays (54% vs. 34%, P = 0.035), possibly related to a higher rate of Pauwels 3 fractures (41% vs. 22%, P = 0.032). In time, quality of life improved more in implant removal patients [+2 vs. -4 points, Short Form 12 (physical component), P = 0.024; +9 vs. 0 points, Western Ontario McMaster Osteoarthritis Index, P = 0.019]. CONCLUSIONS: Implant removal after internal fixation of a femoral neck fracture positively influenced quality of life. Implant removal patients were younger and more often independently ambulatory prefracture, more often had a Pauwels 3 fracture, and an evident implant back-out. Implant removal should be considered liberally for these patients if pain persists or functional recovery is unsatisfactory. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Reliability, validity, and responsiveness of the Western Ontario and McMaster Universities Osteoarthritis Index for elderly patients with a femoral neck fracture.

BACKGROUND: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been extensively evaluated in groups of patients with osteoarthritis, yet not in patients with a femoral neck fracture. This study aimed to determine the reliability, construct validity, and responsiveness of the WOMAC compared with the Short Form-12 (SF-12) and the EuroQol 5D (EQ-5D) questionnaires for the assessment of elderly patients with a femoral neck fracture. METHODS: Reliability was tested by assessing the Cronbach alpha. Construct validity was determined with the Pearson correlation coefficient. Change scores were calculated from ten weeks to twelve months of follow-up. Standardized response means and floor and ceiling effects were determined. Analyses were performed to compare the results for patients less than eighty years old with those for patients eighty years of age or older. RESULTS: The mean WOMAC total score was 89 points before the fracture in the younger patients and increased from 70 points at ten weeks to 81 points at two years postoperatively. In the older age group, these scores were 86, 75, and 78 points. The mean WOMAC pain scores before the fracture and at ten weeks and two years postoperatively were 92, 76, and 87 points, respectively, in the younger age group and 92, 84, and 93 points in the older age group. Function scores were 89, 68, and 79 points for the younger age group and 84, 71, and 73 points for the older age group. The Cronbach alpha for pain, stiffness, function, and the total scale ranged from 0.83 to 0.98 for the younger age group and from 0.79 to 0.97 for the older age group. Construct validity was good, with 82% and 79% of predefined hypotheses confirmed in the younger and older age groups, respectively. Responsiveness was moderate. No floor effects were found. Moderate to large ceiling effects were found for pain and stiffness scales at ten weeks and twelve months in younger patients (18% to 36%) and in the older age group (38% to 53%). CONCLUSIONS: The WOMAC showed good reliability, construct validity, and responsiveness in both age groups of elderly patients with a femoral neck fracture who had been physically and mentally fit before the fracture. The instrument is suitable for use in future clinical studies in these populations. CLINICAL RELEVANCE: The results are based on two clinical trials. The questionnaires used concern pure, clinically relevant issues (ability to walk, climb stairs, etc.). Moreover, the results can be used for future research comparing clinical outcomes (or treatments) for populations with a femoral neck fracture.

Cumulative incidence and treatment of non-simultaneous bilateral femoral neck fractures in a cohort of one thousand two hundred and fifty patients.

PURPOSE: In the Netherlands, over 20,000 patients sustain a hip fracture yearly. A first hip fracture is a risk factor for a second, contralateral fracture. Data on the similarity of the treatment of bilateral femoral neck fractures is only scarcely available. The objectives of this study were to determine the cumulative incidence of non-simultaneous bilateral femoral neck fractures and to describe the patient characteristics and treatment characteristics of these patients. METHODS: A database of 1,250 consecutive patients with a femoral neck fracture was available. Patients with a previous contralateral femoral neck fractures were identified by reviewing radiographs and patient files. Patient characteristics, previous fractures, hip fracture type and details on treatment were collected from the patient files. RESULTS: One hundred nine patients (9%, 95% confidence interval 7-10%) had sustained a non-simultaneous bilateral femoral neck fracture. The median age at the first fracture was 81 years; the median interval between the fractures was 25 months. Overall, 73% was treated similarly for both fractures in terms of non-operative treatment, internal fixation or arthroplasty. In patients with identical Garden classification (30%), treatment similarity was 88%. CONCLUSIONS: The cumulative incidence of non-simultaneous bilateral femoral neck fractures was 9%. Most patients with identical fracture types were treated similarly. The relatively high risk of sustaining a second femoral neck fracture supports the importance of secondary prevention, especially in patients with a prior wrist or vertebral fracture.

Functional outcome after successful internal fixation versus salvage arthroplasty of patients with a femoral neck fracture.

OBJECTIVES: To determine patient independency, health-related and disease-specific quality of life (QOL), gait pattern, and muscle strength in patients after salvage arthroplasty for failed internal fixation of a femoral neck fracture. DESIGN: Secondary cohort study to a randomized controlled trial. SETTING: Multicenter trial in the Netherlands, including 14 academic and nonacademic hospitals. PATIENTS: Patients after salvage arthroplasty for failed internal fixation of a femoral neck fracture were studied. A comparison was made with patients who healed uneventfully after internal fixation. INTERVENTION: None (observatory study). MAIN OUTCOME MEASUREMENTS: Patient characteristics, SF-12, and Western Ontario McMaster osteoarthritis index scores were collected. Gait parameters were measured using plantar pressure measurement. Maximum isometric forces of the hip muscles were measured using a handheld dynamometer. Differences between the fractured and contralateral leg were calculated. Groups were compared using univariate analysis. RESULTS: Of 248 internal fixation patients (median age, 72 years), salvage arthroplasty was performed in 68 patients (27%). Salvage arthroplasty patients had a significantly lower Western Ontario McMaster osteoarthritis index score (median, 73 vs. 90; P = 0.016) than patients who healed uneventfully after internal fixation. Health-related QOL (SF-12) and patient independency did not differ significantly between the groups. Gait analysis showed a significantly impaired progression of the center of pressure in the salvage surgery patients (median ratio, -8.9 vs. 0.4, P = 0.013) and a significant greater loss of abduction strength (median, -25.4 vs. -20.4 N, P = 0.025). CONCLUSIONS: Despite a similar level of dependency and QOL, salvage arthroplasty patients have inferior functional outcome than patients who heal after internal fixation of a femoral neck fracture. LEVEL OF EVIDENCE: Therapeutic level III.

Femoral neck shortening after internal fixation of a femoral neck fracture.

This study assesses femoral neck shortening and its effect on gait pattern and muscle strength in patients with femoral neck fractures treated with internal fixation. Seventy-six patients from a multicenter randomized controlled trial participated. Patient characteristics and Short Form 12 and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores were collected. Femoral neck shortening, gait parameters, and maximum isometric forces of the hip muscles were measured and differences between the fractured and contralateral leg were calculated. Variables of patients with little or no shortening, moderate shortening, and severe shortening were compared using univariate and multivariate analyses. Median femoral neck shortening was 1.1 cm. Subtle changes in gait pattern, reduced gait velocity, and reduced abductor muscle strength were observed. Age, weight, and Pauwels classification were risk factors for femoral neck shortening. Femoral neck shortening decreased gait velocity and seemed to impair gait symmetry and physical functioning. In conclusion, internal fixation of femoral neck fractures results in permanent physical limitations. The relatively young and healthy patients in our study seem capable of compensating. Attention should be paid to femoral neck shortening and proper correction with a heel lift, as inadequate correction may cause physical complaints and influence outcome.

Adherence to a femoral neck fracture treatment guideline.

PURPOSE: In 2007 the Dutch Surgical Society published a clinical practice guideline for the treatment of hip fracture patients, based on the best available international evidence at that time. We investigated to what extent treatment of femoral neck fracture patients in the Netherlands corresponded with these guidelines, and determined differences in patient characteristics between the treatment groups. METHODS: All femoral neck fracture patients treated in 14 hospitals between February 2008 and August 2009 were included. Patient characteristics, X-rays, and treatment data were collected retrospectively. RESULTS: From a total of 1,250 patients 59% had been treated with arthroplasty, 39% with internal fixation, and 2% with a non-operative treatment. While 74% of the treatment choices complied with the guideline, 12% did not. In 14% adherence could not be determined from the available data. Arthroplasty was preferred over internal fixation in elderly patients with severe comorbidity, pre-fracture osteoporosis and a displaced fracture, who were ambulatory with aids pre-fracture (odds ratio, OR 2.2-58.1). Sliding hip screws were preferred over cancellous screws in displaced fractures (OR 1.9). CONCLUSIONS: Overall guideline adherence was good. Most deviations concerned treatment of elderly patients with a displaced fracture and implant use in internal fixation. Additional data on these issues, preferably at a higher scientific level of evidence, is needed in order to improve the guideline and to reinforce a more uniform treatment of these patients.

Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience.

BACKGROUND: Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. METHODS: Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. RESULTS: Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217). CONCLUSIONS: In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00761813.

The epidemic of hip fractures: are we on the right track?

BACKGROUND: Hip fractures are a public health problem, leading to hospitalization, long-term rehabilitation, reduced quality of life, large healthcare expenses, and a high 1-year mortality. Especially older adults are at greater risk of fractures than the general population, due to the combination of an increased fall risk and osteoporosis. The aim of this study was to determine time trends in numbers and incidence rates of hip fracture-related hospitalizations and admission duration in the older Dutch population. METHODS AND FINDINGS: Secular trend analysis of all hospitalizations in the older Dutch population (≥65 years) from 1981 throughout 2008, using the National Hospital Discharge Registry. Numbers, age-specific and age-adjusted incidence rates (per 10,000 persons) of hospital admissions and hospital days due to a hip fracture were used as outcome measures in each year of the study. Between 1981 and 2008, the absolute number of hip fractures doubled in the older Dutch population. Incidence rates of hip fracture-related hospital admissions increased with age, and were higher in women than in men. The age-adjusted incidence rate increased from 52.0 to 67.6 per 10,000 older persons. However, since 1994 the incidence rate decreased (percentage annual change -0.5%, 95% CI: -0.7; -0.3), compared with the period 1981-1993 (percentage annual change 2.3%, 95% CI: 2.0; 2.7). The total number of hospital days was reduced by a fifth, due to a reduced admission duration in all age groups. A possible limitation was that data were obtained from a linked administrative database, which did not include information on medication use or co-morbidities. CONCLUSIONS: A trend break in the incidence rates of hip fracture-related hospitalizations was observed in the Netherlands around 1994, possibly as a first result of efforts to prevent falls and fractures. However, the true cause of the observation is unknown.

Surviving a site audit: tips for good clinical practice in an implant trial.

The number of clinical trials involving implants for trauma and orthopedic surgery is increasing. The International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guideline has been developed in order to assure that the rights, safety, and well-being of trial subjects (i.e., patients) are protected. Not performing a trial according to legal requirements including this guideline is no longer acceptable, and trial audits are increasingly being performed as an independent quality check for data validity and credibility. This manuscript provides an overview of the guideline for Good Clinical Practice (GCP) in the context of conducting an implant trial in trauma and orthopedic surgery. As long as all guidelines are adequately adhered to and all paperwork is in order, there is no reason to fear a trial audit.