Commentary Makaram et al. compare radiographic, clinical, and patient-reported outcomes (PROs) after nailing of 219 consecutive tibial shaft fractures at a level-I trauma center in England using either the newer suprapatellar (SP) or the traditional infrapatellar (IP) insertion technique. The authors have no apparent bias and utilized what appear to be unbiased and appropriate outcome measures, including critical, objective, and reliable assessment of the radiographic entry point (nail insertion-point accuracy, NIPA), alignment, and (in approximately one-half of the patients) 1 to 3-year clinical outcomes (validated PROs including the Lysholm Knee Score [LKS], Oxford Knee Score [OKS], and an analogue scale for satisfaction). Only 8 patients were lost to follow-up (4 due to death). The authors concluded that SP nailing yielded superior radiographic findings (NIPA and malreduction rate, their 2 primary outcome measures) but no difference in the rate of malunion or in any of the PROs (their secondary outcome measures). The implication is that SP may be the "better" of the 2 approaches. I believe that their methodology and results are accurate, but I would draw slightly different conclusions. The primary message of this study, in my opinion, is that the new SP and the old IP approach for nailing tibial shaft fractures give equivalent and very good results. There are slight radiographic advantages to the SP approach, but probably not clinically important ones. Based on the premise that there is an identified "ideal" starting point, the authors were able to objectively and accurately measure the actual entry point (with excellent reliability) and then identify the distance between the 2 points (NIPA). However, the significant improvement in NIPA was only 2 mm (5 versus 7 mm) and probably not clinically important. The malreduction rate was 3% with the SP approach versus 11% with the IP approach, a difference that would appear to be not merely statistically significant but clinically important. However, several of the postoperative malreductions did not result in malunions at healing; there was no difference in the eventual malunion rate. Some of the malreductions apparently healed with improved alignment, and some of the early "malunions" were well reduced on postoperative radiographs. The authors emphasized the higher rate of malreduction with the IP approach, whereas I would also note that finding but emphasize that (1) there was no difference in the ultimate malunion rate, (2) postoperative malreduction does not always cause malunion, and (3) conversely, malunion can occur despite good postoperative alignment, especially in patients older than 60 years. Therefore, the statistically significant difference in malreduction may not be clinically important. The patients in this series were treated at the discretion of the surgeons, including the choice of surgical approach (IP versus SP) as well as what constitutes an "acceptable" reduction. Retrospectively, the authors identified 20 patients with "malreduction" (≥5°). It was not clear if the treating surgeons identified and accepted this angulation or missed it. Occasionally the surgeons did use supplementary techniques (clamps or unicortical plates, but not blocking screws) to obtain reduction. However, it is not clear what the surgeons considered an "acceptable" reduction, meaning one that did not require an intraoperative change. Another conclusion that I draw from these results is that there may be a tendency for more malreductions (fewer "auto-reductions") after the IP than the SP approach and surgeons using the IP approach may need to be more vigilant about avoiding malreductions and resort to more supplemental techniques (clamps, unicortical plates, blocking screws) to obtain and maintain acceptable reduction. SP nailing supposedly improves reduction and is technically easier, but it also supposedly reduces postoperative anterior knee pain1. The authors did not directly measure anterior knee pain, but it is a component of all 3 PROs, and the pain component of the LKS did not differ between the 2 groups. If there was a difference in knee pain between the 2 approaches, it did not result in a difference in these PROs at 1 to 3 years postoperatively. SP nailing is sometimes promoted specifically for more proximal fractures, for which postoperative malalignment after nailing is even more common2. Makaram et al. specifically excluded extreme nailing (of fractures of the proximal or distal tibia), so we do not know if there are advantages to SP nailing in more proximal tibial fractures. There were no patients with fractures centered in the proximal metaphysis or with proximal extension into the knee joint3. Even among the diaphyseal fractures studied by Makaram et al., only 7% were in the proximal one-third of the diaphysis (OTA 42 subgroup 1)4. Their study did not specifically address 2 similar situations in which SP nailing might be superior to IP nailing: proximal tibial metaphyseal fractures (OTA 41A) and fractures involving the proximal third of the tibial shaft (OTA 42 group 1). Additional study of these fracture patterns might show greater benefit of SP nailing, as malreduction (apex anteromedial) has been reported with IP nailing5,6. Nevertheless, the authors have added a good deal of important data in trying to address the issue of the ideal starting point for tibial nailing.
University of NewMexico, Albuquerque,NM The author reports no conflict of interest. T.A. DeCoster was a member of the OTA Classification and Outcomes Committee 2006–2012.
Abstract Introduction: The objectives for this study were to identify whether diagnostic or procedural errors more commonly resulted in lawsuit, as well as to elucidate how specific variables affected mean indemnity. Methods: Systematic review of English-language articles in the PubMed and Google Scholar databases (through 2020) using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Meta-analysis was performed to estimate measures of proportions and differences in mean indemnity. Results: The estimated probability of lawsuits related to orthopedic trauma in overall studies was 23.3%. There were no significant rate differences between main causes of claims (diagnostic vs procedural errors) and areas of injury (upper vs lower). There was no significant difference of mean indemnity between the probabilities of trauma-related claims, diagnostic error, and procedural error. Conclusion: Non-trauma cases were more likely to result in lawsuit than trauma cases. Procedural errors accounted for most malpractice claims. The average indemnity increased according to the higher diagnostic errors, while the indemnity was lower with a relatively higher proportion of procedural errors. The most common cause of litigation varied between studies; however, among the most cited reasons were missed diagnosis/error in diagnosis, improper/substandard surgical performance, and, though not specifically studied in this analysis, errors of informed consent. Level of Evidence: Economic and Decision Analyses Level VI
Femur shaft fractures are common injuries frequently treated with intramedullary fixation. Although satisfactory alignment is usually achieved, malreductions can happen in sagittal and coronal planes, as well as along the longitude axis. The causes of malposition with femoral nailing include fracture location, comminution, and suboptimal technique. We identify the most common patterns of malreduction of nailed femur shaft fractures as well as how to avoid and treat them.
Where Are We Now? Patient-reported outcome (PRO) data are a hot topic in orthopaedics. Some of the emphasis is being pushed on us by outside forces (good or bad), and there is some recognition that traditionally reported outcome measures (for example, operating room time and radiographic alignment) are more important to surgeons than to patients. In my own work on the outcome after distal tibial plafond fractures, many patients with good-looking radiographs were unhappy with their outcome while others with a residual radiographic deformity were happy and functioning better than their radiographically attractive counterparts [1, 3, 12]. It is clear that patients place an importance on different parameters than surgeons do regarding outcomes after orthopaedic trauma and orthopaedic interventions for a variety of pathologic findings. In addition, value-based payments are increasingly based on PROs, but some research suggests that there is a general lack of good PRO measures (PROMs) that are validated, consistent, comparable, and have face validity [9]. PROMs that are not well validated or that do not measure the endpoints we seek may result in misleading conclusions. In the article “Patients Place More of an Emphasis on Physical Recovery Than Return to Work or Financial Recovery” [8], O’Hara et al. found that patients identified physical recovery as the highest priority during the first year after treatment, although return to work and financial recovery became progressively more important over time. The study identified the importance of regularly asking patients about their changing priorities in sequential office follow-up visits during fracture recovery. These findings were independent of the occurrence of complications or patient socioeconomic factors, such as preinjury employment status. After reading this article, I plan to ask and document patients’ general and financial concerns, particularly after the initial treatment, and then inquire about changing concerns over the course of their recovery during the first year. Some of the current limitations to accurately measuring satisfaction (a form of PROs) objectively and quantitatively are well outlined by Ring and Leopold [11]. They emphasized the need for face validity (that is, the measure must reproducibly and accurately reflect the spectrum of a patient’s response to treatment). A useful PRO must minimize the confounding impact of psychological comorbidities. Useful PROs must also measure parameters that are truly important to the patient and that are not merely convenient. For example, patients might want antibiotics for colds and an MRI for their first episode of lumbago (low back pain), but those treatments are not effective and they waste healthcare resources. The narcotic epidemic was partially a response to third-party intervention into the doctor-patient relationship and emphasis on “the fourth vital sign-pain” and right to “freedom from all pain” concept [5]. Fenton et al. [2] reported increased patient satisfaction with increased prescriptions, cost of care, and in-patient location. They also reported an increased death rate, indicating that sometimes giving patients what they want is not good for them. PROs in orthopaedic trauma were discussed at the 2013 Orthopaedic Trauma Association’s annual meeting and recently (November 2020) updated in a webinar called “Utilizing Patient Reported Outcome (PRO) Measures in Orthopaedic Trauma: What Have We Learned and Where are We Headed?” [9]. PROMs are increasingly being reported in orthopaedic studies, and they affect orthopaedic surgeons in terms of reimbursement schemes and credentialing. Unfortunately, there is little validation or standardization of these measures, which limits their utility. Where Do We Need To Go? It is clear that there are gaps in existing knowledge and we need good input data from PROMs if desired results are to be achieved. Current PROMs can be improved by developing and using validated scales and techniques that are comparable and consistent. That will make it possible to compare apples and oranges using standardized scales of objective, quantifiable parameters such as weight and caloric content. PROMs must be flexible, reflecting changing patient priorities as identified by this study [8]. Studies using PROMs also need to account for the variability introduced by psychological comorbidities and be sensitive to situations where there is discrepancy between what patients want and what they need. PROMs must be scientifically sound, and studies using those PROMs must consider known confounding effects. Although PROMs have mostly been applied to specific interventions such as the particular treatment of a particular fracture, there is potential benefit in applying the same concepts to systems-based measurements such as the patient’s evaluation of their overall experience with a doctor or orthopaedic clinic. One controversial topic on this theme is whether providers or healthcare regulators should be the ones to develop, record, and use these measures. Obviously, the perspective of the developer, recorder, or user will be reflected in the nature of the measure. A provider is likely to use a PROM to choose between treatment options for future patients. Regulators and payors will likely use PROMs to make reimbursement and contractual allowance decisions. How Do We Get There? Future studies should compare existing PRO tools in patients treated for common conditions and injuries in order to identify which tools most accurately, sensitively, and easily capture the most-important elements of recovery from musculoskeletal conditions. Validated scales should be identified and promoted for consistent and comparable results between studies. PROMs that are not scientifically sound should be identified and replaced. The American Orthopaedic Foot and Ankle Association has recently started this process [4, 10]. Once validated PROMs are identified, a large number of common orthopaedic interventions should be studied to quantify the value provided by these interventions. Fracture treatment is a great place to start because fractures are common and readily identified by bone segment [7]. Furthermore, a small number of different treatments are used for most fractures, and fracture healing usually occurs over a short period of time (2-6 months), enabling good data acquisition and meaningful comparisons. As in O’Hara et al.’s study [8] in this month’s Clinical Orthopaedics and Related Research®, the changing priorities of patients over time should be identified for a wide variety of conditions, and common patterns should be identified. Techniques need to be developed to allow a given PROM to reflect the patient’s changing priorities over time. Adjusting the weighting given to particular questions or sections is an attractive technique to achieve this goal. In addition to an analysis of the response to an intervention, system-wide evaluations should be performed. Press Ganey and Consumer Assessment of Healthcare Providers and Systems evaluations of hospital systems are in widespread use [6]. Although far from perfect, these tools can be used for this new purpose to provide useful feedback and guidance. Instead of measuring the response to treatment of a fracture, they can measure patient responses to their overall interaction with the orthopaedic clinic. The process of receiving care from an orthopaedic practice can be assessed to potentially provide valuable information to the practice, payors, regulators, patients, and society. Additionally, the American Board of Orthopaedic Surgeons will increasingly incorporate standard PROMs into their board-certification credentialing and maintenance of certification process.
Background: Open tibial plafond fractures (Orthopaedic Trauma Association and AO Foundation [OTA/AO] 43) are associated with severe complications, including deep infection (closed fractures, 20%; open fractures, 30%), amputation (3%-14%), and nonunion (up to 25%). Circular external fixators (CEFs) can minimize soft tissue injury. This study aimed to report the rate of union and occurrence of severe complications in patients with open tibial plafond fractures treated with CEFs. Methods: A retrospective review of case series was conducted at 3 level I trauma centers. The study included patients older than 18 years with open tibial plafond fractures treated with CEFs. The reported outcomes included union rate, deep infection, operative complications, and limb alignment. The radiographic measurements of anatomic alignment were obtained. Fifty-two patients were included in the study. Results: The primary union rate was 79%. No deep infection occurred in the majority (92%) of patients. No patient required amputation of the affected limb or free flap coverage. Conclusion: Definitive fixation of open tibial plafond fractures with CEFs avoided severe soft tissue complications but resulted in variation in final radiographic alignment. Level of Evidence: Level IV, case series.
Femoral shaft fractures are a common orthopaedic injury. They are generally treated with intramedullary nailing. The optimal timing of operative treatment is variable and debated. Relatively simple femoral shaft fractures can be successfully treated in less than 24 hours in most health care systems. Femoral shaft fractures can be more complicated owing to various factors, such as multiple traumatic injuries, associated conditions, etc. These more complicated femoral shaft fractures benefit from stabilization within the first 6 hours to minimize complications. Stabilization of the long bones helps achieve an upright chest position and improves pulmonary, circulatory, and musculoskeletal function. Some patients with multiple severe traumatic injuries may suffer worsening of their general condition and pulmonary status. This article reviews concepts for selecting optimal timing of intramedullary fixation of femoral shaft fractures and reviews relevant current literature.
Femoral shaft fractures are common injuries typically due to high-energy trauma. Injuries associated with femoral shaft fractures include ipsilateral femoral neck fractures, ipsilateral distal femur fractures, ipsilateral patella fractures, ipsilateral tibial shaft fractures, ipsilateral knee ligament injuries, acetabular and pelvis fractures, and small bone fractures. These injuries can go unnoticed, and it is important to recognize and treat these injuries accordingly.
Background Electrical stimulation (EStim) has been proven to promote bone healing in experimental settings and has been used clinically for many years and yet it has not become a mainstream clinical treatment. Methods To better understand this discrepancy we reviewed 72 animal and 69 clinical studies published between 1978 and 2017, and separately asked 161 orthopedic surgeons worldwide about their awareness, experience, and acceptance of EStim for treating fracture patients. Results Of the 72 animal studies, 77% reported positive outcomes, and the most common model, bone, fracture type, and method of administering EStim were dog, tibia, large bone defects, and DC, respectively. Of the 69 clinical studies, 73% reported positive outcomes, and the most common bone treated, fracture type, and method of administration were tibia, delayed/non-unions, and PEMF, respectively. Of the 161 survey respondents, most (73%) were aware of the positive outcomes reported in the literature, yet only 32% used EStim in their patients. The most common fracture they treated was delayed/non-unions, and the greatest problems with EStim were high costs and inconsistent results. Conclusion Despite their awareness of EStim's pro-fracture healing effects few orthopedic surgeons use it in their patients. Our review of the literature and survey indicate that this is due to confusion in the literature due to the great variation in methods reported, and the inconsistent results associated with this treatment approach. In spite of this surgeons seem to be open to using this treatment if advancements in the technology were able to provide an easy to use, cost-effective method to deliver EStim in their fracture patients.
Objective: To compare the rate of malreduction after high fibular fractures associated with syndesmosis injury treated with open reduction and internal fixation, with either 2 screws or 1 knotless TightRope device. Design: Prospective randomized controlled multicenter trial. Setting: Eleven academic and community hospitals including Level 1 and Level 2 trauma centers across Canada. Patients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability after malleolar bony fixation were followed for 12 months after treatment. Methods: Open reduction of the syndesmosis was performed in all cases. Fixation was randomized to either TightRope (1 knotless TightRope, group T) or screw fixation (two 3.5-mm cortical positional screws placed across 3 cortices, group S). Surgical techniques and rehabilitation were standardized. All surgeons were trained or experienced in the use of the TightRope device. Follow-up was performed at 2 and 6 weeks, 3, 6, and 12 months. Main Outcome Measure: Rate of malreduction based on bilateral ankle computed tomography scan results at 3 months after fixation. Secondary outcome measures included adverse events, reoperation, and validated functional outcomes including the EQ-5D, the Olerud–Molander Ankle Score, the Foot and Ankle Disability Index, and the Work Productivity Activity Impairment Questionnaire. The estimated sample size required to detect a difference in reduction rate was 72 patients, but the estimated sample size required to detect a difference in functional outcome scores was 240 patients, suggesting the study was adequately powered for radiographic results only. Results: Overall, the rate of malreduction using screw fixation was 39% compared with 15% using TightRope fixation (P = 0.028, χ2). Analysis of computed tomography results was performed using a 2-mm translation or 10-degree rotation threshold for malreduction and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, and mid); medial compression; and rotation (fibular and articular). Patients in group T had greater anterior translation (5.4 ± 1.8 mm) compared with the contralateral limb (4.3 ± 1.3 mm, P < 0.01) or group S (4.6 ± 1.5 mm, P = 0.05). Group T syndesmoses also had greater diastasis compared with control limb (4.1 ± 1.3 vs. 3.3 ± 1.4 mm, P < 0.01) and less fibular medialization compared with group S (1.04 ± 1.8 vs. 0.3 ± 1.8 mm, P = 0.05). Functional outcome measures demonstrated significant improvements over time, but no differences between fixation groups. Foot and Ankle Disability Index scores at each time interval were 44 ± 22 (T) versus 45 ± 24 (S) (6 weeks), 76 ± 14 versus 73 ± 17 (3 months), 89 ± 10 versus 86 ± 13 (6 months), and 93 ± 9 versus 90 ± 14 (12 months) (all P > 0.2). The reoperation rate was higher in the screw group compared with TightRope (30% vs. 4%, P = 0.02) with the difference driven by the rate of implant removal. Conclusions: Based on our results, the TightRope device seems to compare favorably with two, 3.5-mm, 3-cortex screw fixation for syndesmosis injuries. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Background:Although the rate of non-fatal gunshot wounds (GSW) has increased, few studies have compared the effectiveness of operative and nonoperative treatment with specific focus on infection. We compared the risk of septic arthritis in patients with traumatic arthrotomies caused by GSW treated operatively with irrigation and debridement versus nonoperatively with antibiotics and wound care.Methods:From 2009 to 2016, 46 patients at our institution sustained traumatic arthrotomies from low-velocity GSW with at least 90-day follow-up. Medical records were reviewed for demographic information, imaging, type and duration of antibiotics, details of operative and nonoperative interventions, and evidence of infection at follow-up visits. We measured the rate of septic arthritis using a 2-tailed t test.Results:The knee was the most commonly affected joint (34 patients; 73.9%). Eight patients (17.4%) were treated nonoperatively and 38 (82.6%) were treated operatively. In the nonoperative group, one patient (12.5%) developed a superficial wound infection that resolved with oral antibiotics. In the operative group, one patient (2.6%) developed a superficial wound infection requiring operative irrigation and debridement. There was no statistically significant difference in risk of infection between the two groups (P = 0.32). No patient developed septic arthritis.Conclusions:In select patients, nonoperative treatment with wound care and antibiotics may be sufficient for preventing infection after GSW-related traumatic arthrotomies. Findings of randomized studies and treatment algorithms are needed to further evaluate this relatively common injury.Level of Evidence: IV.
1Department of Orthopaedics and Rehabilitation, University of New Mexico, Albuquerque, New Mexico aE-mail address: [email protected]
Aims This study reviews the use of a titanium mesh cage (TMC) as an adjunct to intramedullary nail or plate reconstruction of an extra-articular segmental long bone defect. Patients and Methods A total of 17 patients (aged 17 to 61 years) treated for a segmental long bone defect by nail or plate fixation and an adjunctive TMC were included. The bone defects treated were in the tibia (nine), femur (six), radius (one), and humerus (one). The mean length of the segmental bone defect was 8.4 cm (2.2 to 13); the mean length of the titanium mesh cage was 8.3 cm (2.6 to 13). The clinical and radiological records of the patients were analyzed retrospectively. Results The mean time to follow-up was 55 months (12 to 126). Overall, 16 (94%) of the patients achieved radiological filling of their bony defect and united to the native bone ends proximally and distally, resulting in a functioning limb. Complications included device failure in two patients (12%), infection in two (12%), and wound dehiscence in one (6%). Four patients (24%) required secondary surgery, four (24%) had a residual limb-length discrepancy, and one (6%) had a residual angular limb deformity. Conclusion A titanium mesh cage is a useful adjunct in the treatment of an extra-articular segmental defect in a long bone. Cite this article: Bone Joint J 2018;100-B:646–51.