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Paul Tornetta

Publications and source records attributed to Paul Tornetta.

54 records · Page 3Linked to original sources

Hierarchy of evidence: from case reports to randomized controlled trials.

In the hierarchy of research designs, the results of randomized controlled trials are considered the highest level of evidence. Randomization is the only method for controlling for known and unknown prognostic factors between two comparison groups. Lack of randomization predisposes a study to potentially important imbalances in baseline characteristics between two study groups. There is a hierarchy of evidence, with randomized controlled trials at the top, controlled observational studies in the middle, and uncontrolled studies and opinion at the bottom. This hierarchy has not been supported in two recent publications in the New England Journal of Medicine which identified nonsignificant differences in results between randomized, controlled trials, and observational studies. The current authors provide an approach to organizing published research on the basis of study design, a hierarchy of evidence, a set of principles and tools that help clinicians distinguish ignorance of evidence from real scientific uncertainty, distinguish evidence from unsubstantiated opinions, and ultimately provide better patient care.

Evidence-Based Medicine↗

Designing, conducting, and evaluating journal clubs in orthopaedic surgery.

The first record of a journal club was that founded in 1875 by Sir William Osler at McGill University for the purchase and distribution of periodicals to which he could not afford to subscribe as an individual. Evidence-based medicine is becoming an accepted educational paradigm in medical education at various levels. An analysis of the literature related to journal clubs in residency programs in specialties other than orthopaedic surgery reveals that the three most common goals were to teach critical appraisal skills (67%), to have an impact on clinical practice (59%), and to keep up with the current literature (56%). The implementation of the structured article review checklist has been found to increase resident satisfaction and improves the perceived educational value of the journal club without increasing resident workload or decreasing attendance at the conference. Periodic evaluation of the conference and the institution of appropriate changes ensures that the journal club remains a valuable and successful part of the training program.

Curriculum↗

Barriers to full-text publication following presentation of abstracts at annual orthopaedic meetings.

BACKGROUND: Oral presentations at national and international meetings offer an excellent forum for the dissemination of current research findings. However, publication rates of full-text articles after presentation of abstracts at international meetings have ranged from 11% to 78%, which suggests that at least 32% of the abstracts presented are never published as complete articles in peer-reviewed journals. In an effort to identify the reasons that surgeons had not had a paper published following presentation of their work at an international orthopaedic meeting, we conducted a survey of a cross section of authors of orthopaedic papers presented at a national meeting. METHODS: We retrieved all abstracts from the 1996 scientific program of the sixty-third Annual Meeting of the American Academy of Orthopaedic Surgeons. A computerized Medline and PubMed search established whether the abstract had been subsequently published as a full-text article. The authors of the abstracts that had not been subsequently published were surveyed to identify the reasons for the failure to publish. RESULTS: A total of 465 abstracts were presented at the sixty-third Annual Meeting of the American Academy of Orthopaedic Surgeons in 1996. We surveyed the authors of 306 abstracts for which we were unable to locate a subsequent full-text publication on Medline. One hundred and ninety-nine investigators (65%) responded to the questionnaire. At the time of the survey, seventy-two manuscripts had been published, thirty-two had been submitted and rejected, fourteen were under consideration by journals, seven had been accepted for publication or were in press, and three were not recalled by the investigator. In addition, seventy-one abstracts (35.7%) of the 199 had not been submitted for publication. The authors of those abstracts were asked to indicate one or more reasons why they had not submitted a manuscript for publication. Thirty-three investigators (46.5%) indicated that they lacked sufficient time for research activities, twenty-two (31.0%) reported that the study presented at the meeting in 1996 was still in progress, fourteen (19.7%) believed that the responsibility for writing the manuscript belonged to someone else, and twelve (16.9%) reported that difficulties with co-authors who would not participate had impeded the completion of the manuscript. Nine investigators (12.7%) responded that the pursuit of publication was a low priority. CONCLUSIONS: In a survey of investigators who had not had a full-text article published after presenting the abstract at a national meeting, we found that the failure to publish was due to one of three main reasons: (1) they did not have enough time to prepare a manuscript for publication (the reason most frequently given); (2) almost one-third of the studies that had not been submitted for publication were ongoing; and (3) relationships with co-authors sometimes presented a barrier to final publication. Thorough preparation before the study and the establishment of stricter guidelines to limit the presentation of preliminary data at national and international meetings may improve publication rates.

Abstracting and Indexing↗

The validity of claims made in orthopaedic print advertisements.

PURPOSE: Orthopaedic surgeons are frequently presented with advertisements for orthopaedic and medical products in which companies make claims of clinical and scientific fact. This study was designed to evaluate the statements made in orthopaedic print advertisements and determine whether they are supported by scientific data. METHODS: Fifty statements from fifty advertisements were chosen at random from six peer-reviewed orthopaedic journals. The companies that placed the advertisements were contacted to provide supporting data for the statement of clinical or scientific fact. Three senior orthopaedic surgeons evaluated the data for quality and support. A high-quality study was defined as a study that could be published in the peer-reviewed literature. A well-supported statement was defined as a statement with enough supporting evidence to be used in clinical practice. The evaluating surgeons were blinded to product and company identification. RESULTS: The supporting data were from a published source for eighteen claims (36%), from a presentation at a public forum or a scientific meeting for twelve claims (24%), or were "data on file" only at the company for twelve claims (24%). Interobserver agreement among the surgeons evaluating the advertisements for quality and support was good (the average intraclass correlation coefficient was 0.72). Of the fifty claims, twenty-two were considered unsupported by scientific data, seventeen were classified as possibly supported, seven were well supported, and four were from companies that did not respond despite three requests. Claims that were supported by published data were significantly more likely to be rated as well supported (p < 0.001). All twelve claims that were supported purely by "data on file" at the company were considered to be poorly supported. CONCLUSIONS: Orthopaedic surgeons should interpret claims made in orthopaedic print advertisements with caution. Approximately half of the claims are not supported by enough data to be used in a clinical decision-making process.

Advertising↗

Internal fixation compared with arthroplasty for displaced fractures of the femoral neck. A meta-analysis.

BACKGROUND: The optimal choice for the stabilization of displaced femoral neck fractures remains controversial, with alternatives including arthroplasty and internal fixation. Our objective was to determine the effect of arthroplasty (hemiarthroplasty, bipolar arthroplasty, and total hip arthroplasty), compared with that of internal fixation, on rates of mortality, revision, pain, function, operating time, and wound infection in patients with a displaced femoral neck fracture. METHODS: We searched computerized databases for randomized clinical trials published between 1969 and 2002, and we identified additional studies through hand searches of major orthopaedic journals, bibliographies of major orthopaedic textbooks, and personal files. Of 140 citations initially identified, fourteen met all eligibility criteria. Three investigators independently graded study quality and abstracted relevant data, including information on revision and mortality rates. RESULTS: Nine trials, which included a total of 1162 patients, provided detailed information on mortality rates over the first four postoperative months, which ranged from 0% to 20%. We found a trend toward an increase in the relative risk of death in the first four months after arthroplasty compared with the risk in the first four months after internal fixation (relative risk, 1.27). At one year, the relative risk of death was 1.04. The risk of death after arthroplasty appeared to be higher than that after fixation with a compression screw and side-plate but not higher than that after internal fixation with use of screws only (relative risk = 1.75 and 0.86, respectively; p < 0.05). Fourteen trials that included a total of 1901 patients provided data on revision surgery. The relative risk of revision surgery after arthroplasty compared with the risk after internal fixation was 0.23 (p = 0.0003). Pain relief and the attainment of overall good function were similar in patients treated with arthroplasty and those treated with internal fixation (relative risk, 1.12 for pain relief and 0.99 for function). Infection rates ranged from 0% to 18%, and arthroplasty significantly increased the risk of infection (relative risk, 1.81; p = 0.009). In addition, patients who underwent arthroplasty had greater blood loss and longer operative times than those who were treated with internal fixation. CONCLUSIONS: In comparison with internal fixation, arthroplasty for the treatment of a displaced femoral neck fracture significantly reduces the risk of revision surgery, at the cost of greater infection rates, blood loss, and operative time and possibly an increase in early mortality rates. Only larger trials will resolve the critical question of the impact on early mortality.

Arthroplasty↗

Treatment of closed tibial fractures.

Closed tibial shaft fractures are common injuries that remain challenging to treat because of the wide spectrum of fracture patterns and soft-tissue injuries. Understanding the indications for surgical and nonsurgical treatment of these fractures is essential for good outcomes. Although cast treatment of stable tibial shaft fractures has traditionally been successful and continues to be widely used, recent clinical studies have shown that intramedullary nails may be more advantageous for fracture healing and function than casting. Surgical treatment (intramedullary nailing, plate fixation, or external fixation) of closed tibial shaft fractures varies depending on multiple factors. Metaphyseal fractures are well suited for plates, although newer intramedullary nail designs provide the option of intramedullary nailing of proximal or distal metaphyseal tibia-fibula fractures. External fixators are well suited for skeletally immature patients with unstable fracture patterns or for patients with unacceptably small intramedullary canals. Interlocking intramedullary nails are the treatment of choice for most unstable tibia-fibula shaft fractures.

Bone Plates↗

High-energy tibial shaft fractures.

High-energy tibial fractures are common injuries that are managed by most practicing orthopaedic surgeons. Many methods of treatment are available. This article reviews the options for skeletal stabilization, the risks and benefits of each, and the necessary concepts that effect outcome.

Bone Plates↗

Percutaneous pin placement in the medial calcaneus: is anywhere safe?

OBJECTIVE: To redefine the medial calcaneal anatomic safe zone for pin placement with respect to reproducible palpable landmarks. DESIGN: Anatomic study. SETTING: Medical school anatomy laboratory. INTERVENTIONS: Thirty-three fresh-frozen adult cadaveric feet were used. Three palpable anatomic landmarks were identified on each ankle and labeled as Point A (posteroinferior medial calcaneus), Point B (inferior medial malleolus), and Point C (navicular tuberosity). The medial neurovascular bundle was carefully dissected, and the medial calcaneal nerve, the most posterior branch of the lateral plantar nerve, the lateral plantar nerve, the medial plantar nerve, and the posterior tibial artery were identified. These structures were recorded at the point at which they transected a line from Point A to B and from Point A to C. Based on the findings of the first thirty-three feet, two pins were placed percutaneously into the medial calcaneus of ten additional feet. Pin 1 was placed one half the distance from Point A to B. Pin 2 was placed one third the distance from Point A to C. The neurovascular structures were then dissected and identified in relation to the pin position. RESULTS: The medial calcaneal, most posterior branch of the lateral plantar, and lateral plantar nerves are at significant risk for abutting the pins or being directly injured at the margins of these relative safe zones. CONCLUSION: The medial calcaneus provides a small window for safe percutaneous pin placement. Posterior to the halfway point from Point A to B and posterior to the one-third mark from Point A to C remain the relatively safest regions; a more posterior placement in the safe zone is safest. Careful blunt dissection and the use of cannulas may help to avoid neurovascular injury.

Ankle Injuries↗

Biomechanical consequences of secondary congruence after both-column acetabular fracture.

OBJECTIVES: To create a both-column acetabular fracture model with secondary congruence and to determine the intraarticular loading characteristics present in simulated single-leg stance. HYPOTHESIS: The normal contact pressures on the weight-bearing portion of the acetabulum in simulated single-leg stance are different from those present in a both-column fracture model exhibiting secondary congruence. DESIGN: Cadaveric Biomechanical model. SETTING: Biomechanical testing laboratory. SPECIMENS: Nine fresh frozen cadaveric hemipelves. INTERVENTION: Both-column fracture model with secondary congruence of the acetabular articular surface with respect to the femoral head was created and tested using Materials Testing Machine (MTS Systems Corp., Minneapolis, MN) and Fuji pressure-sensitive film (Sensor Products, Inc., East Hanover, NJ). OUTCOME MEASUREMENTS: Testing data recorded and analyzed comparing the fractured and unfractured states. RESULTS: With respect to the intact specimen, the contact area, mean pressure, and peak pressure in the dome region all increased (p < 0.003) in the both-column model. The contact area in the anterior articular region decreased (p < 0.02) as did the mean pressure (p < 0.032). The posterior articular region demonstrated a trend toward decreased contact area and increased mean and peak pressures. Descriptively, the stress concentration shifted toward the fracture in all cases with the most anterior and most posterior articular regions having little contact in the fracture model. CONCLUSIONS: In the authors' both-column model of secondary congruence, the stress concentration during simulated single-leg stance was increased significantly in the dome of the acetabulum adjacent to the fracture line.

Acetabulum↗

A lack of consensus in the assessment of fracture healing among orthopaedic surgeons.

BACKGROUND: The assessment of fracture healing is both a clinically relevant and frequently used outcome measure following lower extremity trauma. However, it remains uncertain whether there is a consensus in the assessment of fracture healing among orthopaedic surgeons. Variability in the assessment of healing may have important implications in surgeons' decisions to intervene when they perceive fracture healing is slow to progress. OBJECTIVE: To identify surgeons' approaches in the assessment of tibial fracture healing and the definitions of a delayed union, nonunion, and malunion among orthopaedic surgeons. STUDY DESIGN: Cross-sectional survey of 577 orthopaedic surgeons. METHODS: Focus groups, key informants, and sampling to redundancy strategies were used to develop a survey to examine surgeons' opinions in the assessment of tibial shaft fractures. Surgeons were asked how often the following variables were used in the assessment of fracture healing: (a) callus size; (b) cortical continuity; (c) progressive loss of fracture line; (d) pain with weight bearing; and (e) pain to palpation at the fracture site. Further, surgeons were asked to provide a time point beyond which a delayed union becomes a nonunion. Finally, surgeons specified their limits of acceptable fracture alignment (translation, shortening, rotation, varus/valgus, and procurvatum/recurvatum). The survey was pilot tested for clarity and content validity. This survey was mailed to 577 orthopaedic surgeons who were members of the Orthopaedic Trauma Association, American Academy of Orthopaedic Surgeons, and European-AO International-affiliated trauma centers. RESULTS: Responses were obtained from 444 surgeons (response rate 77%). For each variable, the proportion of surgeons who always used the criterion ranged from 39.7% to 45.4%, and those who occasionally or never used the criterion ranged from 20.7% to 26.9%. Surgeons' definitions of delayed union ranged from 1 to 8 months, whereas definitions of nonunion ranged from 2 to 12 months. There was also variability in definitions of fracture malunion. Acceptable degrees of fracture shortening and translation ranged from less than 5 mm to greater than 15 mm. Surgeons' definitions of acceptable angular malunions (rotational, varus/valgus, and procurvatum/recurvatum) ranged from less than 5 degrees to 20 degrees. CONCLUSIONS: There is a lack of consensus in the assessment of fracture healing in tibial shaft fractures among orthopaedic surgeons. Varying definitions of nonunion and malunion may influence the decision to intervene in an effort to promote fracture healing and/or realign the fracture.

Adult↗

Current practice in the intramedullary nailing of tibial shaft fractures: an international survey.

BACKGROUND: Tibial fractures are the most common of all long bone fractures. Although many tibial fractures may be managed conservatively, a certain subset, including unstable fractures and open fractures, require operative stabilization. Intramedullary nails have become the popular choice of implant in the treatment of tibial shaft fractures. The variability in outcomes with tibial shaft fractures may reflect technical aspects of the surgical procedure and perioperative care regimens among surgeons. Identifying the distribution of surgeons' preferences in nailing technique, and the rationale for their choices, will aid in focusing educational activities for the orthopedic community and planning future clinical trials. Our objectives were to clarify surgeons' opinions regarding technical aspects of surgery and perioperative care after intramedullary nailing of closed and open tibial shaft fractures, and to identify predictors of surgeons' preferences in technique and perioperative care. METHODS: This study was a cross-sectional survey using focus groups, key informants, and sampling to redundancy strategies to develop a survey to examine surgeons' preferences in the treatment of tibial shaft fractures. The survey was pilot tested for clarity and content validity. We mailed this survey in July 2000 to 577 orthopedic surgeons who have an interest in trauma care. These were members of the Orthopaedic Trauma Association, American Academy of Orthopaedic Surgeons, or European AO International affiliated trauma centers. We used several strategies to improve response rates including personalized cover letters, stamped return envelopes, follow-up telephone calls, and repeat mailing of questionnaires. Main outcome measures included technical issues such as reduction, exposure, intramedullary reaming, and interlocking screws; and factors associated with surgeons' preferences such as age, fellowship, academic practice, and geographic location. RESULTS: Four hundred forty-four surgeons (77%) responded. Sixty percent of respondents had an academic practice, 84% supervised residents, and 65.1% had fellowship training in trauma. Approximately half (51.5%) of surgeons used a tourniquet. The odds that a surgeon in Asia or Africa used tourniquets was 10 times that of a North American surgeon (p = 0.004 and p = 0.002, respectively). Patellar tendon retraction and an inferior-based entry portal was the popular choice among surgeons (70.1% and 70.8%, respectively). Surgeons from Australia (odds ratio [OR] = 50, p < 0.001), South America (OR = 9.0, p < 0.001), Europe (OR = 3.7, p = 0.001), and Asia (OR = 3.8, p = 0.006) were significantly more likely to use a patellar splitting approach compared with North American surgeons. In the perioperative care of open tibial shaft fractures, there was consensus in the use of intravenous antibiotics and wound irrigation (96.5% and 95.6%, respectively). However, we found considerable variability in surgeons' preference in wound irrigation pressures (high, 38.7%; low, 45.4%). Surgeons in South America were 10 times more likely to use low-pressure irrigation than North American surgeons (p = 0.0005). In grade IIIB open tibial shaft fractures, 94% of surgeons believed wound closure should be obtained within the first 7 days after the injury. A surgeon's geographic location was a significant predictor of the timing of soft tissue coverage (p = 0.001). CONCLUSION: Consensus in the use of irrigation and intravenous antibiotics in open fractures was achieved among surgeons. However, there remains considerable variability in the surgical technique of intramedullary nailing, the duration of antibiotic use, and the timing of wound closure in open tibial fracture care. Continued education and large multicenter trials are needed to establish best practice in the operative treatment of tibial shaft fracture.

Adult↗

Effect of continuous versus dichotomous outcome variables on study power when sample sizes of orthopaedic randomized trials are small.

It is often not feasible to conduct large trials in orthopaedic surgery. Therefore, surgeons must identify strategies to optimize the statistical power of their smaller studies. The aim of this study was to compare study power in randomized trials with continuous versus dichotomous outcome variables. We performed a systematic review of the literature to identify randomized trials in orthopaedic trauma. Of these, we examined only those trials with small sample sizes (50 patients or less). The outcomes in each eligible study were categorized as continuous or dichotomous. Standard power calculations were performed for each study, and comparisons were made between continuous and dichotomous outcome variables. We identified 196 randomized trials in orthopaedic trauma. Of these, 76 trials had a sample size of 50 patients or fewer (29 trials with continuous outcomes, 47 trials with dichotomous outcomes). Studies that reported continuous outcomes had a significantly higher mean power than those that reported dichotomous variables (power 49% vs 38%, p=0.042). Twice as many trials with continuous outcome variables reached acceptable levels of study power (i.e. >80% power) when compared with trials with dichotomous variables (37% vs 18.6%, p=0.04). When orthopaedic surgeons anticipate small sample sizes for their study, they can optimize their study's statistical power by choosing a continuous outcome variable.

Cluster Analysis↗

Displaced intra-articular calcaneal fractures.

BACKGROUND: Calcaneal fractures comprise 1 to 2 percent of all fractures. Approximately 75% of calcaneal fractures are intra-articular. The management of intra-articular calcaneal fractures remains controversial. Nonoperative treatment options include elevation, ice, early mobilization, and cyclic compression of the plantar arch. Operative treatment options include closed reduction and percutaneous pin fixation, open reduction and internal fixation, and arthrodesis. The effect of operative versus nonoperative treatment has been the focus of several comparative studies. OBJECTIVE: This study was designed to determine the effect of operative treatment compared with nonoperative treatment on the rate of union, complications, and functional outcome after intra-articular calcaneal fracture in adults.

Ankle Injuries↗