Leveraging Real-World Evidence: A Paradigm Shift in Regulation.

The study methodology and regulatory frameworks for real-world data collection is quickly evolving, opening new avenues to use valid and robust real-world evidence (RWE) to support regulatory decision making. Although the Food and Drug Administration has historically accepted specific applications of RWE to support regulatory determinations, significant progress has been made in recent years to examine conditions in which this information can be used to support specific types of premarket decisions. Of note, hybrid study designs that incorporate aspects of randomized clinical trials, including randomization and pragmatic outcomes, are expected to be a driving factor to accelerate the adoption of RWE in regulatory contexts.

The repair of horizontal cleavage tears yields higher complication rates compared to meniscectomy: a systematic review.

Purpose: Horizontal cleavage tears of the meniscus (HCTs) are primarily degenerative in nature, and, however, can be the result of trauma. Such tears account for 12-35% of all tear patterns and can be treated by partial meniscectomy or arthroscopic repair. The purpose of this review was to systematically assess the outcomes and complications for patients undergoing the surgical treatment of HCTs.

AO Patient Outcomes Center: Design, Implementation, and Evaluation of a Software Application for the Collection of Patient-Reported Outcome Measures in Orthopedic Outpatient Clinics.

Background: Patient-reported outcomes are increasingly utilized in routine orthopedic clinical care. Computer adaptive tests (CATs) from the Patient-Reported Outcomes Measurement Information System (PROMIS) offer a brief and precise assessment that is well suited for collection within busy clinical environments. However, software apps that support the administration and scoring of CATs, provide immediate access to patient-reported outcome (PRO) scores, and minimize clinician burden are not widely available.

Outcomes after orthopedic trauma.

Background: Clinical orthopedic research needs better ability to assess patient expectations with regard to orthopedic trauma surgery outcomes. The aim of this study was to investigate to which extent patient expectations prior to surgery could be met after surgery.

Methods: Patients (≥18 years) with surgical ankle fractures were prospectively recruited at 5 orthopedic trauma clinics in the United States (USA), Canada, and Brazil and followed up for 12 months.

The effect of local bone mineral density on the rate of mechanical failure after surgical treatment of distal radius fractures: a prospective multicentre cohort study including 249 patients.

Introduction: The aim of this prospective, multicentre study was to evaluate the influence of local bone mineral density (BMD) on the rate of mechanical failure after locking plate fixation of closed distal radius fractures.

Materials And Methods: Between June 2007 and April 2010, 230 women and 19 men with a mean age of 67 years were enrolled. Dual energy X-ray absorptiometry measurements for BMD of the contralateral distal radius were made at 6 weeks post-surgery.

The Influence of Local Bone Density on the Outcome of One Hundred and Fifty Proximal Humeral Fractures Treated with a Locking Plate.

Background: There is biomechanical evidence that bone density predicts the mechanical failure of implants. The aim of this prospective study was to evaluate the influence of local bone mineral density on the rate of mechanical failure after locking plate fixation of proximal humeral fractures.

Methods: We enrolled 150 patients who were from fifty to ninety years old with a closed, displaced proximal humeral fracture fixed with use of a locking plate from July 2007 to April 2010.

Factors predicting surgeons' preferred and actual roles in interactions with their patients.

Background: Although shared decision making offers clinical benefits, there is a lack of research investigating physicians' roles in interactions with their patients. Research examining what characterizes physicians who involve patients in decision making is also limited. The authors investigated surgeons' preferred and usual roles in interactions with patients, and whether these roles are influenced by their gender, experience, area of expertise, numeracy, and cultural background.

TEFTOM: A Promising General Trauma Expectation/Outcome Measure-Results of a Validation Study on Pan-American Ankle and Distal Tibia Trauma Patients.

Background. In orthopedics, there is no instrument specifically designed to assess patients' expectations of their final surgery outcome in general trauma populations. We developed the Trauma Expectation Factor Trauma Outcome Measure (TEFTOM) to investigate the fulfilment of patients' expectations one year after surgery as a measure of general trauma surgical outcomes.

Evaluating implants in orthopaedic trials: tips for conducting research.

The availability of quality research on orthopaedic implants is important for orthopaedic clinical practice, though in many cases such research is deficient in the literature. Randomized trials are dwarfed in number by observational studies which, though also valuable, do not provide the same validity of evidence. This is partly due to the unique challenges faced by orthopaedic clinicians when attempting to conduct randomized trials in areas such as randomization, blinding, and follow-up.

Challenges in conducting multicenter, multicultural, and multilingual trials: a view from the literature and real-life experience reports.

A trend toward international multicenter clinical trials in the medical device industry is helping to increase recruitment figures and to improve the generalizability of results, among other factors. However, working globally creates its own unique set of problems, which are rarely discussed in the literature. This article considers these issues from multicenter, multicultural, and multilingual perspectives.

Viscosupplementation for knee osteoarthritis: current evidence and recommendations.

Osteoarthritis (OA) is the most common joint disorder worldwide and is a leading cause of pain and disability. Appropriate management of younger patients with milder disease remains a challenging area of intense research. Viscosupplementation attempts to restore the biomechanical and biochemical functions of normal synovial fluid hyaluronic acid.

The natural history of knee osteoarthritis: India-based knee osteoarthritis evaluation (iKare): a study protocol.

Methodology: Multi-center, cross-sectional, observational study. STUDY CENTER(S): Multiple centers in India. NUMBER OF PARTICIPANTS: 1,000.

Clinical outcome of implant removal after fracture healing. Design of a prospective multicentre clinical cohort study.

Background: The clinical results of removal of metal implants after fracture healing are unknown and the question whether to remove or to leave them in is part of discussion worldwide. We present the design of a prospective clinical multicentre cohort study to determine the main indications for and expectations of implant removal, the influence on complaints, the incidence of surgery related complications and the socio-economic consequences of implant removal.

Methods/design: In a prospective multicentre clinical cohort study at least 200 patients with a healed fracture after osteosynthesis with a metal implant are included for analyzing the outcome after removal.

Implant removal of osteosynthesis: the Dutch practice. Results of a survey.

Background: The aim of this survey study was to evaluate the current opinion and practice of trauma and orthopaedic surgeons in the Netherlands in the removal of implants after fracture healing.

Methods: A web-based questionnaire consisting of 44 items was sent to all active members of the Dutch Trauma Society and Dutch Orthopaedic Trauma Society to determine their habits and opinions about implant removal.

Results: Though implant removal is not routinely done in the Netherlands, 89% of the Dutch surgeons agreed that implant removal is a good option in case of pain or functional deficits.

How to document and report orthopedic complications in clinical studies? A proposal for standardization.

Introduction: The documentation of complications is critical for the evaluation of therapeutic interventions in orthopedics. However, there is a lack of accepted methodological standardization and definitions. We propose a concept to support the consensus development of a standardized management and classification of complications in clinical research.

What should an ideal spinal injury classification system consist of? A methodological review and conceptual proposal for future classifications.

Since Böhler published the first categorization of spinal injuries based on plain radiographic examinations in 1929, numerous classifications have been proposed. Despite all these efforts, however, only a few have been tested for reliability and validity. This methodological, conceptual review summarizes that a spinal injury classification system should be clinically relevant, reliable and accurate.

A critical appraisal of the SPRINT trial.

The Study to Prospectively evaluate Reamed Intramedullary Nails in Tibial fractures (SPRINT) was a randomized controlled trial to evaluate rates of reoperation and complications resulting from reamed versus unreamed intramedullary nailing for the treatment of tibial shaft fractures. The trial found a possible benefit for reamed intramedullary nailing in patients with closed tibial fractures, but no difference was found between the 2 approaches in patients with open fractures. This article is a review and critique of the methodology used in the SPRINT trial.

Evidence-based orthopedic surgery: is it possible?

The promise of evidence-based medicine is to integrate the highest levels of clinical data with patient outcomes. After framing the question and identifying appropriate studies, evaluating their relevance to clinical practice is highly dependent on the instruments and measures selected to demonstrate outcomes. Currently, there are hundreds of outcomes measures available in the orthopedic literature evaluating these treatments, and it is not uncommon for different measures to produce conflicting results.

Can orthopedic trials change practice?

Background And Purpose: The impact of large, randomized trials in orthopedic surgery on surgeons' preferences for a particular surgical approach remains unclear. We surveyed surgeons to assess whether they would change practice based upon results of a large, multicenter randomized controlled hip fracture trial.

Methods: We conducted a cross-sectional survey among International Hip Fracture Research Collaborative (IHFRC) surgeons and surgeons who were members of Arbeitsgemeinschaft fuer Osteosynthesefragen - Association for the Study of Internal Fixation (AO/ASIF) to determine the likelihood that they would change practice based on findings of a proposed large, multicenter randomized controlled trial (the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH) study).