Objectives: The FAITH trial evaluated effects of sliding hip screws versus cancellous screws in femoral neck fracture patients. Using FAITH trial data, we quantified changes in living status, use of aids, and investigated factors associated with living and walking independently 12 months after fracture. Methods: We conducted a descriptive analysis to quantify patients' changes in living status, use of aids, and used multivariable Cox regression analyses to determine factors associated with living and walking independently after fracture. Results: Of patients who lived independently before hip fracture, 3.07% (50–80 years old) and 19.81% (>80 years old) were institutionalized 12 months after injury. Of patients who were walking independently before injury, 33.62% (50–80 years old) and 69.34% (>80 years old) required a walking aid 12 months after injury. Factors associated with higher chances of living independently included the following: being between 50 and 80 years, having a class I American Society of Anesthesiologists classification, not using a walking aid before fracture, being a nonsmoker or former smoker, and having an acceptable quality of implant placement. Factors associated with higher chances of walking without an aid included the following: being between 50 and 80 years, having a class I American Society of Anesthesiologists classification, living independently before fracture, being a nonsmoker or former smoker, having an undisplaced fracture, and not requiring revision surgery. Conclusions: Femoral neck fracture patients suffer great losses of independence. Identifying factors associated with living and walking independently after hip fracture may help surgeons better identify which patients are at risk and optimize care of patients with this injury. Level of Evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

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).

Background The traditional view that the vast majority of midshaft clavicular fractures heal with good functional outcomes following non-operative treatment may be no longer valid for all midshaft clavicular fractures. Recent studies have presented a relatively high incidence of non-union and identified speciic limitations of the shoulder function in subgroups of patients with these injuries. Aim A prospective, multicentre randomised controlled trial (RCT) will be conducted in 21 hospitals in the Netherlands, comparing fracture consolidation and shoulder function after either non-operative treatment with a sling or a plate fixation. Methods/design A total of 350 patients will be included, between 18 and 60 years of age, with a dislocated midshaft clavicular fracture. The primary outcome is the incidence of non-union, which will be determined with standardised X-rays (Antero-Posterior and 30 degrees caudocephalad view). Secondary outcome will be the functional outcome, measured using the Constant Score. Strength of the shoulder muscles will be measured with a handheld dynamometer (MicroFET2). Furthermore, the health-related Quality of Life score (ShortForm-36) and the Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure will be monitored as subjective parameters. Data on complications, bone union, cosmetic aspects and use of painkillers will be collected with follow-up questionnaires. The follow-up time will be two years. All patients will be monitored at regular intervals over the subsequent twelve months (two and six weeks, three months and one year). After two years an interview by telephone and a written survey will be performed to evaluate the two-year functional and mechanical outcomes. All data will be analysed on an intention-to-treat basis, using univariate and multivariate analyses. Discussion This trial will provide level-1 evidence for the comparison of consolidation and functional outcome between two standardised treatment options for dislocated midshaft clavicular fractures. The gathered data may support the development of a clinical guideline for treatment of clavicular fractures. Trial registration Netherlands National Trial Register NTR2399