Characteristics and Discrepancies in Publication of Clinical Trials Related to Foot and Ankle Surgery

Category: Other Introduction/Purpose: The significance of trial registration has grown rapidly as an increasing number of journals require NCT IDs prior to publication. Although various reports have been published in different medical fields, including several orthopaedic subspecialties, no study has examined the discrepancies between trial registries and publications in the area of foot and ankle surgery. Therefore, this study aimed to investigate (1) the characteristics of foot and ankle surgery-related clinical trials registered in the widely used Clinicaltrials.gov (CTG) clinical trials database, (2) the publication rates, (3) inconsistencies between the original trial plans and final publications, and (4) possible risk factors that could contribute to discrepancies. The hypothesis was that foot and ankle surgery-related trials would have a low publication rate, and discrepancies would exist between trial registries and final published results. Methods: The study used the CTG database to identify eligible trials based on the following inclusion criteria: (1) related to foot and ankle surgery, (2) interventional study, (3) randomized controlled, and (4) anticipated completion date before the end of 2018. Exclusion criteria consisted of (1) ongoing trials, (2) trials assessing vascular surgeries or anesthetic procedures, and (3) trials examining conservative treatment methods without any surgical intervention. The search was performed on January 1, 2021, allowing the authors at least 24 months from trial completion to publication. The corresponding publications of the included trials were searched using various databases, including Medline, Web of Science, Scopus, and Google Scholar. NCT ID, title, keywords, and the name of the principal investigator provided in CTG were used for literature search, and the title and abstract of the publications were reviewed to confirm the match with the trial. Results: Out of all the trials analyzed, 67.5% were registered either during the trial period or after completion. Industry funded 46.5% of trials. A reported 54.8% of trials were completed, and only 42% (66 trials) were published in a journal. Among the analyzed trials, 57.6% had a sample size discrepancy, 28.8% had a follow-up time discrepancy, 45.5% had a primary outcome discrepancy, and 89.4% had an inclusion/exclusion criteria discrepancy. Trials funded by industry exhibited significantly more sample size and inclusion/exclusion criteria discrepancies (p=0.024, 0.001, 0.037, respectively). Furthermore, industry-funded studies had a higher frequency of positive results (p=0.011). Conclusion: The findings of this study draw attention to the existing issues in clinical trials related to foot and ankle surgery. The results not only serve as a warning to researchers regarding potential inconsistencies but also support the need for stricter trial registry regulations. Registering a trial does not guarantee its publication or ensure that there will be no modifications to the methodology during the trial period. Therefore, it is crucial to register trials before enrolling the first patient to minimize the risk of bias

Do Arch Supports Alter Foot Alignment in Patients with Metatarsalgia? A Weightbearing CT and x-ray Study

Category: Midfoot/Forefoot; Lesser Toes Introduction/Purpose: Arch-support insoles are frequently included in the treatment plans for common foot ailments including metatarsalgia. Literature has demonstrated that insoles with metatarsal and arch support could relieve walking pain and improve patient-reported measures of function in metatarsalgia. The purpose of this study was to examine alterations in foot alignment among metatarsalgia patients who used arch support insoles. Methods: A clinical trial was initiated after the approval by the institutional review board. Patients with metatarsalgia (age: 18-65 y/o) were included after they consented to participate. Individuals with open wounds, feet asymmetry, using assistive device or brace, and those with BMI more than 35 were excluded. Participants underwent weightbearing computed tomography (WBCT), and weight-bearing x-ray of their feet while standing barefoot or on the insoles (Good Feet™, Dr.’s Own, LLC). The radiological measurements on WBCT and X-rays conducted in these patients are shown in Table 1. The Wilcoxon-Signed Rank test was used for comparison of the continuous measurements, and the interobserver reliability was analyzed with Intraclass Correlation Coefficient (ICC). Results: Ten patients with a mean age of 46.9±13.06 years were included in the study. Observed changes on X-rays include decreased 4th-5th intermetatarsal angle (p=0.04), 2nd-4th/2nd-5th metatarsal tangent angles (p=0.003, p=0.001), and 1st metatarsal length on antroposterior (AP) view (p=0.02). Also, 1st metatarsal declination angle (p=0.002), and talo-first metatarsal angle on AP view (p=0.05) were increased. No significant changes on the WBCT were found, except for a decrease in the first metatarsal pronation angle (p=0.02). Conclusion: Arch support insoles can bring about anatomical changes especially in the forefoot area of patients with metatarsalgia. While the causal correlation between these changes and alleviation of the symptoms cannot be proven based on our data, these outcomes can guide future clinical trials comparing different treatment for metatarsalgia to determine contributing factors to the healing process of this condition

A Prospective Randomized Study Comparing the Outcomes of Fixed vs Non-Fixed Middle-Sized Posterior Malleolus Fractures

Category: Ankle; Trauma Introduction/Purpose: The controversy surrounding the indications for fixation of posterior malleolar fractures remains unresolved, particularly in cases of middle-sized fragments that make up between 10-25% of the joint surface. Although several studies have been conducted, the evidence to support the need for fixation of such fragments is limited, with a lack of level 1 evidence. This study aimed to assess patients with ankle fractures involving middle-sized posterior fragments and compare those who received posterior malleolus fixation to those who did not. The hypothesis was that fixation of middle-sized (10-25%) posterior malleolar fractures would result in superior functional and radiological outcomes in the short to mid-term follow-up. Methods: A prospective randomized-controlled study was conducted to assess the effects of posterior malleolus fixation in patients with acute rotational ankle fractures involving a middle-sized fragment. Eligible patients were included and randomly allocated into two groups, Group 1 receiving open reduction and internal fixation without posterior malleolus fixation, and Group 2 receiving the same procedure with posterior malleolus fixation, following informed consent. Prior to the study, a power analysis was conducted, indicating that a minimum of 16 patients in each group would be necessary to achieve 80% power and a 5% significance level. The randomization was conducted using an even/odd numbers technique, resulting in 20 patients in each group. Patient clinical and functional status was evaluated annually postoperatively, utilizing the VAS pain scale, AOFAS and SMFA scales. Radiological evaluations were conducted through direct radiographs, utilizing articular step-off evaluation and the Kellgren Lawrence osteoarthritis grading system. Results: The groups were comparable in terms of age, BMI, gender, and fracture type distribution. There were no significant differences in average follow-up times, posterior malleolus size, or height values. However, articular step-off greater than 1mm was more common in Group 1 (p=0.04). Despite slightly better functional outcomes in Group 2, there were no significant differences between the two groups in terms of VAS pain, AOFAS, or SMFA scores (functional, bothersome, and total). However, there was a trend towards significance in the SMFA Function score difference (p=0.07). Multivariate analysis showed that Haraguchi type 1 fractures had better functional outcomes in only the SMFA Bothersome parameter (p=0.03). Patients with articular step-off greater than 1 mm had significantly worse outcomes in all SMFA and AOFAS parameters (p < 0.05). Conclusion: In patients with closed rotational ankle fractures involving medium-sized (10-25%) posterior fragments, there was no significant improvement in functional or radiological outcomes with posterior fragment fixation at short to mid-term follow-up. Patients without posterior fixation were more likely to have articular step-off greater than 1 mm, which was associated with poorer functional outcomes. Despite similar outcomes in both groups, posterior fragment fixation may decrease the incidence of articular step-off and contribute to improved functional outcomes

Chevron vs Oblique Medial Displacement Calcaneal Osteotomy - Which Is More Stable? Results From a Finite Element Analysis Study

Category: Hindfoot; Ankle Introduction/Purpose: The medial displacement calcaneal osteotomy is used to correct hindfoot valgus in adult-acquired flatfoot disease(AAFD). This is done by means of an oblique cut, which is then translated medially. The chevron variant of the MDCO has gained popularity in recent times. This osteotomy involves a V-cut, with the apex of the V placed anteriorly. This is thought to be inherently more stable than the conventional MDCO owing to its geometrical design and higher contact area, especially with higher magnitudes of translation of the osteotomized fragment. However, it is technically more demanding, and many surgeons may not be familiar with the technique. Moreover, there is no literature comparing the stability of the chevron and oblique MDCO. Hence, we conducted this study to address this knowledge gap. Methods: Computed Tomography (CT) scan of the foot of a patient diagnosed with Johnson stage 2 AAFD was segmented and converted into a 3D computational model. Subsequently, oblique and chevron (160o V-angle) calcaneal osteotomies were performed virtually. For each variant, the osteotomized fragment was translated medially by 8-, 10- and 12-mm and then fixed virtually with two 6.5 mm screws. The six models were imported into a Finite Element Software (ANSYS v19) and subjected to 500 N axial loading through the tibia to simulate a single-leg stance. The von Mises stresses at the osteotomy interfaces and the screws, and the total displacement of the posterior fragment was recorded for each model. Results: The compiled simulation results are presented in Table 1. For both osteotomies, the overall stresses at the osteotomy contact site and the screws increased incrementally with increasing medial translation. Similarly, sagittal plane displacement of the anterior fragment was noted to follow a similar trend. Across all translation levels, the stresses were recorded to be lower for chevron MDCO when compared to the oblique variants. Relative fragment displacement was also noted to be lower for the chevron MDCO. Conclusion: The chevron osteotomy results in lower contact stresses and osteotomy fragment displacement and may prove to be a more stable alternative to the oblique MDCO. However, these results need to be replicated in a larger cohort of patients, as well as in cadaveric studies to determine if surgeons can permit early weight-bearing with the chevron MDCO

Clinical Outcomes of Insertional Achilles Tendinopathy Patients Treated with Reattachment and Dorsal Closing Wedge Calcaneal Osteotomy: A Meta-analysis

Category: Hindfoot; Sports Introduction/Purpose: Posterior heel pain at the Achilles tendon insertion is a prevalent and debilitating condition that is not yet fully understood. It results from a combination of bony and soft tissue abnormalities, including insertional Achilles tendinopathy, retrocalcaneal bursitis, and posterosuperior bony prominence. While the most commonly used surgical technique for treatment is debridement and reattachment of the tendon, dorsal closing wedge calcaneal osteotomy (DCWCO) has recently gained popularity. In this meta-analysis, we aimed to analyze the published literature related to both surgical techniques and compare their outcomes. Our hypothesis was that DCWCO can provide similar clinical outcomes with a lower complication rate. Methods: We conducted a literature search in Medline, Embase, and Scopus databases. Clinical studies reporting at least one of the clinical outcomes among AOFAS score and complications, with an open technique and sufficient data to extract and pool, were included. The extraction was made by two users using the Covidence platform. Studies with less than 10 patients or less than 12 months follow-up were excluded. Initial search yielded 329 papers, and after excluding duplicates and irrelevant studies, 43 papers were left. After a full-text review of these 43 papers, we found 15 papers eligible for meta-analysis. We used the Modified Coleman Methodology to assess the quality of papers. Results: Out of the 15 articles, seven included reattachment patients, while eight included DCWCO patients. 171 feet underwent reattachment, while 239 feet underwent DCWCO. The average follow-up of patients was significantly higher in the DCWCO group (42.2 months) than reattachment group (23.2 months). The average AOFAS score improvement was similar between the groups. The total complication numbers were 30 (16.6%) in the reattachment group and 28 (9.2%) in the DCWCO group, but the difference did not reach significance since the confidence intervals were overlapping. However, wound complications were significantly more common in Reattachment group (10.1%) compared to DCWCO (2.5%). The number of revision surgeries and neurological complications (sural neuritis, hypersensitivity, etc.) were similar between the groups. The average AOFAS score improvement was similar between the groups. Conclusion: Both techniques yielded comparable clinical outcomes. The overall complication rate was similar, but DCWCO exhibited a lower wound complication rate than reattachment. Therefore, the study results imply that DCWCO can provide similar clinical outcomes with fewer wound complications. However, further well-designed studies are necessary to reach a definitive conclusion on this matter and compare both techniques in the same study setting

Three-Dimensional Mapping of Chaput Tubercle Fractures: Evaluation of Morphologic Characteristics and Anterior Inferior Tibiofibular Ligament Involvement

Category: Ankle; Trauma Introduction/Purpose: Chaput tubercle fractures, which are thought to represent tibial-sided avulsions of the anterior inferior tibiofibular ligament (AITFL), are prevalent in up to 30% of trimalleolar ankle fractures. The optimal treatment of small Chaput avulsions is debatable; direct fixation with suture anchor devices and indirect (syndesmotic) fixation are considered as viable options, with proponents on both sides. Moreover, recent literature highlights the potential anatomical alterations to the incisura tibialis resulting from malreduction of large Chaput fragments, furthering the case for direct fixation. Hence, we performed a CT- based three-dimensional fracture mapping study to identify the morphological characteristics of these fractures, and to determine whether they consistently involve the AITFL, tibial plafond and incisura tibialis. Methods: This study included adult patients who had an ankle fracture with a Chaput component; the scheme described by Rammelt et al. was used to classify these fractures. CT scans were obtained, and 3D models were generated. The models were superimposed over a statistical shape model of the right tibia which served as a template and fracture lines were marked. The footprints of proximal and main bands of the AITFL and Basset’s ligament were also marked on the template tibia. The tibial template along with the fracture lines was then imported into MATLAB, and an automated script was used to determine the fragment size (length, breadth, and height), fracture surface area, involvement of the tibial plafond, tibial incisura, and the anterior inferior tibiofibular ligament (AITFL) and Basset’s ligament. Fracture maps and heat maps were generated. Agglomerative cluster analysis using Ward’s linkage was used to identify discrete fracture categories. Results: 76 patients, 21 males and 55 females were included in this study. Cluster analysis identified two distinct groups of fractures, each with two unique subgroups. We present this as a modification of the existing classification system. The first group, corresponded to Rammelt Type 1 fractures (sub centimetric extra-articular avulsion fractures, n=47). Of these, 19% (n=9) did not involve the AITFL, which we termed as Type 1a, and 91% (n=48) involved the AITFL, which we termed as Type 1b. The second group consisted of large intra-articular fractures that corresponded to Rammelt Type 2 injuries. Of these 23% (n=6) involved only the incisura, which we termed as Type 2a; 77 % involved both the incisura and the tibial plafond and were termed as Type 2b. Conclusion: We propose a modification of the existing classification of Chaput fractures on the basis of quantitative fracture mapping. This study provides new insights into the morphological characteristics of Chaput fractures. 19% of small Chaput fractures do not involve the AITFL and may not require direct fixation. Conversely, all large-sized fragments involve the incisura and necessitate anatomical reduction to achieve accurate syndesmotic reduction. Our proposed modification can aid in surgical decision-making, particularly in choosing between direct and indirect syndesmotic fixation

Effect of Dorsal Closing Wedge Calcaneal Osteotomy on Foot Alignment and Biomechanics in Patients with Insertional Achilles Tendinopathy

Category: Hindfoot; Sports Introduction/Purpose: The use of a dorsal closing wedge calcaneal osteotomy (DCWCO) in the treatment of insertional Achilles tendinopathy (IAT) has recently gained popularity. The anatomical changes imposed by the osteotomy are believed to improve both the biological and mechanical processes involved in IAT. However, the impact of shortening the Achilles leverage arm after DCWCO and the full impact of DCWCO on foot anatomy and function is not well understood. This study aimed to examine the effects of DCWCO on the 3D alignment and biomechanics of the foot and ankle in IAT patients through simulated models of DCWCO. The hypothesis was that DCWCO would significantly impact foot alignment and decrease gastrocsoleus lever arm. Methods: Six weightbearing ankle CTs of patients with IAT were identified from the clinical database. Bone segmentation was performed and DCWCOs were conducted in standardized planes with six variations, resulting in a total of 36 foot models. Two plantar osteotomy starting points were defined as 1-cm anterior (posterior osteotomy) and 2-cm anterior (anterior osteotomy) to the most plantar point of calcaneus. The osteotomies were extended to dorsal surface at 1-cm anterior to posterosuperior calcaneus with 6, 10, or 14-mm wedges anteriorly. After the osteotomies, the posterior part of the calcaneus was rotated around the plantar starting point until proper bone contact was achieved. Achilles reconstruction was also performed using pre-defined Achilles insertion points. All models were then transferred to a MATLAB-based algorithm for automated measurements. These measurements included talocalcaneal, calcaneal pitch, Böhler, and Achilles tendon sagittal angles, Achilles moment arm, Achilles- posterosuperior calcaneus distance, and difference in soleus-Achilles length. Results: Anteriorly placed osteotomy caused more significant decrease in the Böhler angle (p < 0.001). Evaluation of the posteriorly placed osteotomy separately showed no significant decrease in the Böhler angle for patients with more than 30- degrees of preoperative Böhler angle (p=0.26). However, patients with a preoperative Böhler angle less than 30-degrees showed a significant decrease, approaching values close to 5-degrees (p=0.004). Gastrocsoleus moment arm decrease was found to be 2-3% by using force/moment equation. The change in the distance between Achilles tendon and the posterosuperior calcaneus was similar between anterior and posterior osteotomies, with less than 3-mm in a 6-mm wedge and more than 5-mm in a 10-mm wedge osteotomy. The calculations showed that ankle dorsiflexion can increase by one degree for each mm of resection. Conclusion: An anteriorly placed starting point for a DCWCO can negatively affect foot alignment and offer limited benefits for Achilles decompression. If the preoperative Böhler angle is less than 30, a DCWCO can significantly decrease the Böhler angle, potentially putting the subtalar joint at risk for arthritis by increasing the load as reported by some finite element studies. The maximum decrease in gastrocsoleus power is less than 3%, which may be clinically insignificant. A posterior starting point with 10- mm wedge can be adequate to move Haglund around 5-mm anteriorly and can move Achilles insertion 10-mm superiorly to decrease tension

Validation of the Angle Bisector Method for Precise Tibiofibular Syndesmosis Fixation Angle Using Computed Tomography and 3D-Printed Models

Category: Ankle; Trauma Introduction/Purpose: The proposed ideal alignment for the syndesmosis involves a line connecting the centroids of the fibula and tibia, but there is uncertainty about the optimal intraoperative method for determining the appropriate fixation angle. This is due to the fact that the AO guidelines do not account for patient or level-specific factors, and the determination of the angle relative to the coronal plane relies on the surgeon's judgment. Inexperienced trauma surgeons may encounter significant problems with syndesmotic malalignment as a result. The goal of this study was to validate the effectiveness of the angle bisector method using computed tomography and 3D-printed ankle models, in order to determine whether it can assist in achieving proper screw trajectory for syndesmotic fixation. Methods: The angle bisector method was utilized to identify a precise trajectory for the true syndesmotic axis, using the bisector of the angle formed by two lines tangential to the anterior and posterior fibula and tibia. CT validation was made on CT angiography of 50 consecutive patients. DICOM data from 16 ankles were used to create 3D anatomical models which were printed using a desktop FDM printer. Two trauma surgeons performed syndesmotic fixations using the angle bisector method at 2 cm and 3.5 cm proximal to the joint space, after identifying the bisector of the angle formed by two K-wires tangential to the anterior and posterior fibula and tibia. The axial sections of CTs and printed 3D-models were analyzed using software to determine the relationship between centroidal axis and the inserted screws. The measurements were made twice by two blinded observers, with a two-week interval. Results: The results of the study show that the angle bisector method provides a reliable direction with minimal differences at both the 2 cm and 3.5 cm levels. The average angle between the centroidal axis and screw trajectory was 2.4° ± 2° at the 2 cm level and 1.3° ± 1.5° at the 3.5 cm level. Furthermore, the average distance between the fibular entry points of the centroidal axis and screw trajectory was less than 1 mm at both levels, indicating that the angle bisector method can serve as an excellent entry point for syndesmotic fixation on the fibula. The inter- and intra-surgeon analyses showed excellent consistency, with all ICC values above 0.90. Similarly, inter- and intra-observer consistencies regarding the measurements were also excellent. Conclusion: The study demonstrated that the angle bisector method was successful in identifying the original syndesmotic axis and aided in the precise placement of implants in the desired direction. The method has the potential to be replicated intraoperatively and could serve as a basis for the development of a novel surgical guide for determining the correct syndesmotic axis. However, safety analysis using cadavers should be conducted prior to clinical implementation

Congruent Weber-B Ankle Fractures do not affect Tibiotalar Contact Mechanics: No Need for the Scalpel?

Category: Trauma; Ankle Introduction/Purpose: Weber-B ankle fractures represent an increasingly common injury world-wide, and the decision for operative fixation often hinges on the stability and congruency of the ankle. While tibiotalar displacement is typically evaluated using the medial clear space on plain radiographs, this method remains prone to inaccuracy because of x-ray beam rotation and manual measurement errors. Furthermore, the influence of these fractures on the mechanical environment of the ankle remains unknown. The recent advent of weightbearing cone-beam CT (WBCT) overcomes these drawbacks by imaging during bipedal stance, allowing a 3D anatomical and mechanical analysis. Therefore, the aim of this study was to analyze the 3D mortise displacement and contact mechanics in weber B ankle fractures by use of WBCT in comparison to their healthy contralateral side. Methods: In this retrospective study, our ankle trauma database was searched for Weber-B ankle fractures imaged by bilateral WBCT imaging between 2015 and 2022. Exclusion criteria consisted of metal or motion artifacts, presence of ankle osteoarthritis, and an age less than 18 years or more than 75 years. Segmentation into 3D models of bone was performed semi-automatically, while personalized cartilage layers were modeled based on a previously validated methodology. Bilateral ankle models were imported in custom-made Matlab® script for an automated anatomical and mechanical analysis. 3D mortise congruency was evaluated by use of following parameters: fibular length, talocrural angle, distance mapping of the medial gutter and tibiofibular clear space distance mapping. Contact mechanics were evaluated by the mean and maximum contact stress of the tibia and talus, as well as the contact area (Figure 1). A student’s T-test was performed to investigate the difference between the fractured and healthy side. Results: Thirty-two patients, with mean age 38.50 years (SD = 15.81 ) and weight 79.12 kg (SD = 16,24), were confirmed eligible for analysis. Statistical analysis revealed that there were no significant differences for all anatomical parameters (P > 0.05). The mean contact stress of the fractured and healthy side was 2.10 (SD = 0.42) MPa and 2.10 (SD = 0,41) MPa, respectively, whereas the maximum stress was 7.67 MPa (SD = 1.55) and 7,47 MPa (SD = 1,67), respectively. No statistical significant differences were found between all mechanical parameters (P > 0.05). Conclusion: This study demonstrates that contact mechanics are not affected in Weber-B fractures with a congruent mortise. Therefore, non-operative treatment could be considered, as there will theoretically be no increased risk for the patients to develop posttraumatic osteoarthritis in the long term. In clinical practice, WBCT could prove useful to determine the 3D anatomical and mechanical environment of ankle fractures and guide patients towards (non-) operative treatment. However, further studies should focus on the minimal clinical important difference/rehabilitation factors associated with mortise malalignment based on concomitant contact stress increase, which would warrant and identify which cases need surgical reduction