Designing clinical studies in orthopedic traumatology.

The design of clinical studies in orthopedic traumatology is challenging in several respects. In this era of evidence-based medicine, the pressure is high to choose our treatments solely based on randomized controlled studies. This type of study, when well-constructed, makes it possible to discern the best treatment for a specific fracture in a given group of patients and in connection with a specific outcome. Randomized controlled trials require a lot of resources and are not designed to answer all research questions. Observational studies, such as case-control studies, prospective cohort studies, and cross-sectional studies, also have a role to play in improving scientific knowledge in orthopedic trauma. Regardless of the type of study chosen, the researcher must follow a strict methodology that conforms to practice guidelines in order to ensure the study's conclusions are valid. The guidelines for randomized studies can be found at http://www.consort-statement.org and at http://www.strobe-statement.org for cohort studies. It is also very important to register randomized studies before they begin on a website such as http://www.clinicaltrials.gov, since registration is an increasingly common requirement when submitting an article for publication. Although this preparation is relatively cumbersome, it is essential for producing articles that meet modern scientific criteria.

Clinical impact of positive Propionibacterium acnes cultures in orthopedic surgery.

BACKGROUND: The clinical significance of a positive culture to Propionibacterium acnes in orthopedic specimens remains unclear, whether about its role as a contaminant or a pathogen, or its impact as a coinfectant. Therefore, we performed a retrospective study to provide a more accurate description of the clinical impact of P. acnes in an orthopedic population aiming to determine: 1) if there is a clinical difference between P. acnes infection and contamination? 2) If there is a clinical difference between P. acnes monoinfection, and coinfection. HYPOTHESIS: There is a clinical difference between P. acnes infection and contamination. MATERIALS AND METHODS: Patients were selected over a five-year period, and those with a minimum of one positive culture for P. acnes, from any intraoperative orthopedic tissue sample, were included in the study. P. acnes infection was defined as the isolation of P. acnes from≥2 specimens, or in only one specimen, in the presence of typical perioperative findings and/or local signs of infection. RESULTS: A total of 68 patients had a positive P. acnes culture, 35 of which were considered to be infected. The infections affected mostly males (29/35-83%), occurred mostly in shoulders (22/35-63%), and at a site already containing an orthopedic implant (32/35-91%). Local inflammatory signs were present in half of the cases when an infection was diagnosed. Coinfection with other pathogens was present in 31% of patients (11/35). When comparing patients coinfected with P. acnes, and those who were monoinfected, the latter presented less often with local inflammatory signs. Recurrence rate was 24% (8/35) and the only risk factor for recurrence was the presence of a monoinfection. DISCUSSION: This study confirms the pathogenicity of P. acnes in an orthopedic population, as it is present in multiple samples in the same patient, and because it is present in cultures from cases with clinical recurrence. Our study showed that monoinfections differ from coinfections mainly by their higher risk of recurrence. LEVEL OF EVIDENCE: Level IV retrospective case series.

Translation and validation of the PREE (Patient Rated Elbow Evaluation) to a French version.

BACKGROUND: Only a few outcome measures specific to elbow pathology and the assessment of their impacts on function are valid and reliable when used in French speaking populations. The English version of the Patient Rated Elbow Evaluation (PREE) was determined to be an optimal candidate for translation. HYPOTHESIS: A French version of the PREE (PREE-Fr) will be generated and compared to its original version in terms of reliability and responsiveness. MATERIALS AND METHODS: The PREE was translated following the guidelines of the American Academy of Orthopedic Surgeons. Patients with a variety of elbow pathologies completed the French version of the PREE (PREE-Fr), the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) and the Mayo Elbow Performance Score (MEPS) on three different occasions. The test-retest reliability of the PREE-Fr was calculated using questionnaires that were filled out with a one-week interval between them. The responsiveness was assessed using questionnaires filled out six months after treatment. RESULTS: A French version of the PREE was generated. Data gathered from 54 patients yielded an intra-class correlation coefficient for reliability of 0.89 (CI95%: 0.79-0.94) for the PREE-Fr. For construct validity, using the Pearson correlation coefficient, we obtained excellent correlation between the PREE-Fr and QuickDASH at day one, one week and six months (0.89-0.96) while that between the PREE and MEPS was good to excellent (0.70-0.95). Responsiveness of the PREE-Fr was assessed and yielded a standardized response mean of 1.03, meaning that a large change was recorded between day one and six months. DISCUSSION: The PREE-Fr should be considered in French speaking populations for patients with elbow pathology, whether it is for research or evaluation purposes as it is valid, reliable and responsive to change.

Validity, reliability and responsiveness of the French language translation of the Western Ontario Shoulder Instability Index (WOSI).

BACKGROUND: The WOSI (Western Ontario Shoulder Instability Index) is a self-administered quality of life questionnaire designed to be used as a primary outcome measure in clinical trials on shoulder instability, as well as to measure the effect of an intervention on any particular patient. It is validated and is reliable and sensitive. As it is designed to measure subjective outcome, it is important that translation should be methodologically rigorous, as it is subject to both linguistic and cultural interpretation. OBJECTIVE: To produce a French language version of the WOSI that is culturally adapted to both European and North American French-speaking populations. MATERIALS AND METHODS: A validated protocol was used to create a French language WOSI questionnaire (WOSI-Fr) that would be culturally acceptable for both European and North American French-speaking populations. Reliability and responsiveness analyses were carried out, and the WOSI-Fr was compared to the F-QuickDASH-D/S (Disability of the Arm, Shoulder and Hand-French translation), and Walch-Duplay scores. RESULTS: A French language version of the WOSI (WOSI-Fr) was accepted by a multinational committee. The WOSI-Fr was then validated using a total of 144 native French-speaking subjects from Canada and Switzerland. Comparison of results on two WOSI-Fr questionnaires completed at a mean interval of 16 days showed that the WOSI-Fr had strong reliability, with a Pearson and interclass correlation of r=0.85 (P=0.01) and ICC=0.84 [95% CI=0.78-0.88]. Responsiveness, at a mean 378.9 days after surgical intervention, showed strong correlation with that of the F-QuickDASH-D/S, with r=0.67 (P<0.01). Moreover, a standardized response means analysis to calculate effect size for both the WOSI-Fr and the F-QuickDASH-D/S showed that the WOSI-Fr had a significantly greater ability to detect change (SRM 1.55 versus 0.87 for the WOSI-Fr and F-QuickDASH-D/S respectively, P<0.01). The WOSI-Fr showed fair correlation with the Walch-Duplay. DISCUSSION: A French-language translation of the WOSI questionnaire was created and validated for use in both Canadian and Swiss French-speaking populations. This questionnaire will facilitate outcome assessment in French-speaking settings, collaboration in multinational studies and comparison between studies performed in different countries. TYPE OF STUDY: Multicenter cohort study. LEVEL OF EVIDENCE: II.

Heterotopic ossification following total hip replacement for acetabular fractures.

Early total hip replacement (THR) for acetabular fractures offers accelerated rehabilitation, but a high risk of heterotopic ossification (HO) has been reported. The purpose of this study was to evaluate the incidence of HO, its associated risk factors and functional impact. A total of 40 patients with acetabular fractures treated with a THR weres retrospectively reviewed. The incidence and severity of HO were evaluated using the modified Brooker classification, and the functional outcome assessed. The overall incidence of HO was 38% (n = 15), with nine severe grade III cases. Patients who underwent surgery early after injury had a fourfold increased chance of developing HO. The mean blood loss and operating time were more than twice that of those whose surgery was delayed (p = 0.002 and p < 0.001, respectively). In those undergoing early THR, the incidence of grade III HO was eight times higher than in those in whom THR was delayed (p = 0.01). Only three of the seven patients with severe HO showed good or excellent Harris hip scores compared with eight of nine with class 0, I or II HO (p = 0.049). Associated musculoskeletal injuries, high-energy trauma and head injuries were associated with the development of grade III HO.The incidence of HO was significantly higher in patients with a displaced acetabular fracture undergoing THR early compared with those undergoing THR later and this had an adverse effect on the functional outcome.

Proximal humerus fractures treated by percutaneous locking plate internal fixation.

INTRODUCTION: There is no consensually accepted recommendation for optimum surgical treatment of unstable fractures of the proximal humerus. HYPOTHESIS: Locked and minimally-invasive plating is a promising treatment option. MATERIALS AND METHODS: The aim of this prospective, multicentric study is to describe a recently introduced surgical technique for proximal humeral fractures and to evaluate the radiographic and clinical outcomes of this operation. Closed and minimally-invasive reduction is first performed. A proximal humerus specific locking plate featuring multiple-angle screws is secondly implanted. Proper identification and protection of the axillary nerve with the index finger during plate insertion on the lateral humeral side is highly advisable. If it can't be palpated, a classic delto-pectoral approach should be preferred. Thirty-four patients were included in this study with a 1-year minimal postoperative follow-up. Twenty-two patients presented a two-part surgical neck fracture according to the Neer classification and 12 patients had a three-part valgus-impacted fracture. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant scoring systems were used for functional evaluation. RESULTS: Specifically, no axillary nerve injury and no loss of reduction were observed. The median Constant score and the mean DASH score were 82 and 26 respectively at 1-year follow-up. The age-adjusted functional scores values were satisfactory. Two of the patients (6%) required surgical revision for intra-articular screw penetration. DISCUSSION: Our study suggests that percutaneous plating with angular screw fixation of proximal humeral fractures is a safe and effective method, which produces good functional and radiologic outcomes. These minimally-invasive techniques allowing a better preservation of soft-tissues help promote early functional recovery. This more friendly approach combined to upgraded implants and instruments will also improve early and long-term outcomes of these fractures.