bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cartiva: A Retrospective Multicenter Report
Authors: Casscells Nicholas , Dean Daniel M. , Cooper Paul S. , Miller Stuart D. , Guyton Gregory P. 
Published: November 2020

Category: Midfoot/Forefoot; Other Introduction/Purpose: Arthritis of the 1st metatarsophalangeal (MTP) joint is a common condition. Traditionally, advanced disease has been treated with arthrodesis. In 2016, Cartiva, a cylindrical polyvinyl 1st MTP implant, was approved for use in this condition by the FDA upon the basis of a company-sponsored, nonblinded, randomized controlled trial (MOTION) that reported noninferiority to arthrodesis at a -15% difference of proportions margin using a multipart ad hoc definition of surgical success. A subsequent independent level IV case series reported poor PROMIS score outcomes for the procedure but lacked any preoperative data. We report the short-term reoperation rate and pre- and postoperative VAS pain score outcomes for Cartiva in an independent multicenter series. Methods: A retrospective, multicenter review was performed of patients who had a Cartiva hemiarthroplasty placed from 2016- 18 and who had at least 6 months of follow-up. Demographic information, surgical data, and prospectively collected VAS pain scores on a 0-100 point scale on were reviewed. The primary endpoint was reoperation of the implant, defined as removal or revision during the follow-up period. Implant subsidence was measured by comparing early postoperative radiographs with final radiographs. Subgroup analysis was performed comparing Cartiva failures to the remainder of the group. Results: Fifty-three patients with 56 operated toes were included. Forty-seven (88.7%) females and 6 (11.3%) males had a mean age of 57.7 +- 7.14 years (range 43-73). At an average follow-up of 11.1 +- 4.24 months, there were 6 (10.7%) reoperations. Younger age was the only factor found to be associated with failure of the implant (p=.043). Radiographic subsidence >1 mm was identified in 26.6% of patients but did not correlate with failure. VAS pain scores improved from a preoperative average of 49.7 +/- 24.8 to a postoperative average of 33.1 +- 23.3 at final follow-up. Despite this improvement, 40.4% of patients failed to show a 30% improvement, the MCID, in their VAS pain score, and 42.6% of patients had residual pain scores above 30. Conclusion: Our cohort had a 10.7% reoperation rate for the Cartiva implant which is comparable to the results of the MOTION trial. Although aggregate results demonstrated a statistically significant improvement in VAS pain scores, many patients failed to have a satisfactory outcome as demonstrated by the large standard deviation and low achievement of the MCID. Compared to the 1-year results of the MOTION study, our final VAS pain scores were slightly worse, but the very high variance mirrored that reported in the company-sponsored trail (17.8 +- 23.0). This suggests that use of Cartiva does not reliably produce satisfactory pain outcomes.
Comparison of Outcomes of Cheilectomy with and without Synthetic Hydrogel Interposition (Cartiva®)
Authors: Ford Samuel E. , Scott Daniel J. , Alejandro Shannon F. , Vier David D. , Zide Jacob R. , Brodsky James W. 
Published: November 2020

Category: Midfoot/Forefoot; Other Introduction/Purpose: Cheilectomy and arthrodesis are the primary surgical treatments of hallux rigidus. While cheilectomy preserves limited motion, that motion can be the source of persistent pain that later requires arthrodesis. Cheilectomy with interposition arthroplasty using a synthetic hydrogel implant (Cartiva) has been proposed as an alternative to arthrodesis. Previous studies compared Cartiva to arthrodesis, but Cartiva is really a modification of cheilectomy, meant to improve its results by distracting the bony surfaces of the first MTP joint. This study compared outcomes of cheilectomy with Cartiva to cheilectomy alone. Methods: A retrospective cohort study assessed the results at 1-year minimum follow-up, identifying patients by CPT code for cheilectomy with (28291) and without (28289) Cartiva interposition. There were forty-five patients: 26 in the Cartiva group and 19 in the cheilectomy group. Tabulated data included: age, gender; preoperative, 6-month, and final postoperative total first MTP ranges of motion (ROM); preoperative and final postoperative VAS and SF-36 scores; and reoperation information. Hallux rigidus grade was assessed by Coughlin and Shurnas criteria. First MTP joint space was measured at the medial, midline, and lateral portions of the joint on both AP and lateral radiographs before, immediately following, and at maximum postoperative follow-up (16 month mean). For analysis, medial, midline, and lateral joint measurements were averaged to generate a composite measure of radiographic joint space. Follow-up means were 23 months for all patients, 18 for Cartiva and 28 for cheilectomy. Results: Mean age was 54. Mean preoperative grade was 2.6 for Cartiva and 2.1 for cheilectomy (p=0.037). Mean preoperative ROM was 44°. At 1 year follow-up, ROM was 39° for Cartiva and 47° for cheilectomy (p=0.95). Mean VAS improved from 5.8 to 2.0 and 3.0 for Cartiva and cheilectomy, respectively, at final follow-up (p=0.002, p=0.004). Following Cartiva, two week postoperative joint space means increased: AP midline 1.4 to 2.6 mm, AP composite 1.4 to 2.2 mm, and lateral midline 1.3 to 2.7 mm (p<0.001). At final follow-up, joint space measures returned to levels similar to cheilectomy: AP midline 1.3 vs. 1.2 mm, AP composite 1.1 vs. 1.2 mm, and lateral midline 1.6 vs. 1.2 mm (p>0.3). Five patients in each group (22%) underwent revision. Conclusion:: Cartiva offers similar intermediate-term ROM preservation and pain relief as cheilectomy in a cohort with higher grade hallux rigidus. Joint distraction gained by synthetic hydrogel interposition subsides with time to levels similar to cheilectomy. Revision surgery for persistent pain is common in both groups.
Extensile Anteromedial Approach for Total Ankle Arthroplasty
Authors: Kayum Shahin , Khan Ryan M. , Lee Jong Min , Daniels Timothy R. 
Published: November 2020

Category: Ankle Introduction/Purpose: Wound complications can lead to devastating outcomes in major ankle procedures such as total ankle arthroplasty. Up to 28% wound healing complications have been reported with anterior approach to the ankle. Anteromedial approach is an angiosome based approach for ideal wound healing especially in those with high risk factors. Methods: The procedure includes the following steps: 1. Make the Incision along the medial border of the anterior angiosome fed by anterior tibial artery and dorsalis pedis 2. Create full thickness lateral flap by dissecting through the extensor retinaculum, along the course of the tibialis anterior tendon 3. Stay sutures are placed full thickness through the retinaculum and EHL, the full thickness flap is then retracted laterally with the anterior neurovascular bundle 4. The interval between the tibialis anterior tendon and lateral flap is used to perform the total ankle replacement 5. Adequate and full exposure of the distal tibia and ankle joint is achieved. Retrospective chart review of patients who underwent anteromedial approach for elective ankle procedures from Jan 2012 to 2018 was performed. Patient demographics (age, BMI), medical comorbidities, smoking status, pertinent trauma history, follow up duration, and wound complications were collected. Results: Total 73 patients underwent extensile anteromedial approach. Mean age was 48, mean follow up was 24 (range 12 to 73) months. There were no instances of skin flap necrosis. One patient with chronic venous insufficiency developed a small superficial wound infection that healed with dressing changes alone. Conclusion: Anteromedial approach to ankle is a reasonable alternative to standard anterior approach to achieve optimal wound healing in ankle procedures in a high-risk patient for wound healing. The approach allows complete access to the ankle joint keeping the angiosomes intact which helps in excellent wound healing. [Figure: see text]
Biomechanical Comparison of FiberTape Device Repair Techniques of Ligamentous Lisfranc Injury in Cadaveric Model
Authors: Koroneos Zachary , Vannatta Emily , Kim Morgan S. , Fritsche Madelaine W. , Cowman Trevin , Kunselman Allen , Lewis Gregory , Aynardi Michael C. 
Published: November 2020

Category: Trauma; Basic Sciences/Biologics; Midfoot/Forefoot; Sports Introduction/Purpose: Lisfranc ligamentous injuries are complex. Controversy exists regarding their treatment and preferred method of fixation. Fixation methods employing a FiberTape device and interference screw fixation have been described as an alternative to traditional screw fixation. The purpose of this biomechanical study was to evaluate two methods of fixation utilizing interference screw fixation with FiberTape augmentation in a cadaveric model. Methods: 9 paired cadaveric feet (mid tibia/fibula) were separated into two groups based on fixation method: FiberTape alone and FiberTape with supplementary limb into the middle cuneiform via anchor. At three joints of the midfoot (second metatarsal - medial cuneiform, intermediate cuneiform - medial cuneiform, second metatarsal - intermediate cuneiform), the diastasis and relative angular displacement between bones in the coronal plane were measured for static and cyclic loading. Measurements were obtained for the native (pre-injured), injured, and post-fixation in static loading. Fixed specimens then underwent stepwise increases in cyclic loading performed at 1 Hz and 100 cycles, at 100 N intervals from 500 to 1800 N ground reaction force. The Achilles tendon was also loaded to simulate postoperative weightbearing. Failure of fixation was defined as diastasis at the second metatarsal - medial cuneiform joint greater than 2 millimeters. Results: FiberTape specimens demonstrated diastasis failures of 3 of 9 (33%) specimens at cyclic loads of 1000 N. Conversely, FiberTape with supplementary limb specimens all survived past this loading magnitude, with 1 failing at supraphysiologic loads (>1200 N). The difference in diastasis at the second metatarsal-medial cuneiform joint was statistically significant between the two groups at forces of 1600N (p = 0.019) and 1800N (p = 0.029). There were no significant differences between the other joint diastases and relative angular displacements. Conclusion: The use of FiberTape for fixation of ligamentous Lisfranc injuries appears to provide a biomechanically viable alternative for withstanding early post-operative protected weightbearing. Furthermore, the use of a supplementary limb in addition to the FiberTape fixation method appears to enhance its biomechanical efficacy under cyclic loading especially at higher loads.
Two Year Follow-Up of Patient Reported Outcomes Following Third Generation Minimally Invasive Chevron Akin Osteotomies (MICA) in Hallux Valgus Surgery
Authors: Lewis Thomas L. , Ray Robbie , Gordon David 
Published: November 2020

Category: Bunion Introduction/Purpose: The aim of this study was to explore the 2 year results of third generation (using screw fixation) Minimally Invasive Chevron and Akin osteotomies (MICA) for hallux valgus correction. There is a paucity of published data regarding the outcomes of this relatively new technique. We present the largest series in the literature, using three separate validated patient-reported outcome measures (EQ-5DL, VAS Pain and Manchester Oxford Foot Questionnaire (MOXFQ), for this time point. Methods: A single surgeon case series of patients with hallux valgus underwent primary third generation minimally invasive chevron and akin osteotomies for hallux valgus correction. Between August 2015 and January 2018, 290 MICAs were performed in 203 patients that were eligible for 2 year follow up. Baseline and 2 year post-operative patient reported outcomes were collected for 164 feet in 130 patients (124 females; 6 males). Paired t-tests were used to determine the statistical significance of the difference between pre- and post-operative scores. Results: The mean age was 56.6 (range 29.5-81.0, standard deviation (s.d.) 10.9). At two year follow up, mean MOXFQ scores improved for each domain: Pain; baseline 40.6 (range 0-100, s.d. 22.8), reduced to 11.3 (range 0-75, s.d. 16.0, p<0.001); Walking; 36.0 (range 0-100, s.d. 25.9) reduced to 8.2 (range 0-75.0, s.d. 16.0, p<0.001); Social interaction; 46.7 (range 0-100, s.d. 24.3), reduced to 7.7 (range 0-75.0, s.d. 13.9, p<0.001). Mean VAS Pain score improved from 30.4 (range 0.0-90.0, s.d. 23.6) to 9.4 (range 0.00-70.0, s.d. 15.6, p<0.001). Mean EQ-5D index score improved from 0.750 (range 0.066-1.000, s.d. 0.148) to 0.892 (range 0.410-1.000, s.d. 0.135, p<0.001). Mean EQ-5D VAS score did not significantly improve from 81.9 (range 0-100, s.d. 17.1) to 83.0 (range 0-100, s.d. 18.0, p=0.559). Conclusion: This is the largest prospective case series of short-term patient reported outcomes using a validated assessment method for hallux valgus, following third generation MICA to date. These data show that this technique is effective at improving foot and ankle specific patient reported outcomes at 2 years. This cohort is being followed over the longer term.
Assessing Hallux Valgus using Automatically Segmented Weight Bearing CT Datasets: A Case-Control Study
Authors: Lintz Francois , Bernasconi Alessio , Fernando Céline , Netto Cesar de Cesar 
Published: November 2020

Category: Bunion; Midfoot/Forefoot Introduction/Purpose: Hallux Valgus (HV) is a complex 3D deformity. Coronal rotation of the first column has been advocated as a key component of its pathophysiology. Cone Beam Weightbearing CT (CB-WBCT) provides 3D images of the foot and ankle bones under physiological load and may provide any absolute or relative measurements. However, the fact that numerous bones and joints are concerned makes analysis time-consuming and results difficult to render and interpret. Artificial Intelligence based Automatic Segmentation (AIAS) is a new tool which allows for volumetric identification and localization of bones. The objective of this study was to use this tool to obtain exhaustive measurements of the whole first column relative to the second and third columns in HV and compare them to the normal population. Methods: Retrospective comparative, level III study including 16 HV cases and 16 controls matched for age, sex and BMI. Bilateral CB-WBCT images performed as standard care were available for each patient. Inclusion criteria were clinically identified HV cases with first intermetatarsal angle (IMA) >10° and HV angles (HVA) >15° as measured on digitally reconstructed radiographs. Patients under 18 years of age, history of trauma or surgery resulting in a potential modification of the forefoot were excluded. Datasets were analyzed using AIAS software which provided: 3D coordinates for spatial position and orientation and angles of the first, second and third metatarsals and cuneiforms, sesamoids, first phalanx of the first ray, navicular, talus, calcaneus. Normality was assessed using a Shapiro-Wilk test and differences between means were calculated using Welch’s unequal variances t-test. Results:: Mean age and BMI were respectively 57.25 +- 9.65 years and 22.23 +- 2.85 kg.m2; 93.75% (31/32) feet came from women. The mean IMA was 12.9° +- 3° in HV and 8.7° +- 1.4° in controls. In the axial plane, the following measurements were found to be significantly different: IMA (p<0.001), first tarsometatarsal angle (p<0.001) and first-fifth metatarsal angle (p=0.001). In the coronal plane, sesamoid angle (p<0.001), sesamoid shift (p<0.001) and sesamoid rotation (p<0.001) were found significantly different, while first metatarsal torsion was similar in the two groups (p=0.347). Conclusion:: The main finding of this study is that AIAS provided an exhaustive series of measurements in the 3 planes of space which were efficient in discriminating between HV and controls with highly significant figures, even when small numerical differences were observed. The introduction of CB-WBCT, which provides images taken during physiological standing stance, followed by the elaboration of data through AIAS (in order to determine absolute or relative positions of bones in space) may help increase efficiency in clinical daily practice.
Adverse Events Related to Polyvinyl Alcohol Hydrogel Hemiarthroplasty of 1st Metatarsal: An Analysis of Reports to the United States Food and Drug Administration
Authors: Metikala Sreenivasulu , Khamis Karim Mahmoud , O’Connor Kathryn , Chao Wen , Wapner Keith L. , Farber Daniel C. 
Published: November 2020

Category: Midfoot/Forefoot Introduction/Purpose: Polyvinyl Alcohol Hydrogel (PAH) hemiarthroplasty has gained popularity in the operative management of symptomatic hallux rigidus since its introduction to the US in July 2016. Despite encouraging initial results, any implant has the potential for complications that may not become apparent until it is in widespread use. Also, the series of publications supporting the effectiveness of PAH have come from a limited group of institutions and surgeons which creates an opportunity for observational bias. Other complications or unsatisfactory outcomes may be under-reported, such as those experienced in community centers due to the challenges in publishing lower volume work. In order to look at a broader range of potential complications, we reviewed the United States Food and Drug Administration’s (FDA) database and compared with published literature. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database of the US Food and Drug Administration (FDA) was retrospectively reviewed between July 2016 and October 2019 using the assigned product code: PNW for the PAH implant. All the reported adverse events, implant-related complications, and secondary procedures were analyzed. Results: A total of 49 events have been reported to this voluntary database over the past 3 years while over 22,000 Cartiva devices have been implanted. Implant subsidence was the most common with 16 reported instances. Fragmentation of the device was observed in nine and four reports were related to infection in which two were deep infections needing antibiotic spacers. Bone erosion managed by grafting was documented in three reports and foreign body reaction was noted in one. Persistent pain and swelling were common presentations. Thirty-five of 49 reported events required additional operative procedures performed at a mean interval of 4.75 months following the index procedure while four more were awaiting further surgery. Conversion to fusion was the most common procedure, featured in 10 reports. Conclusion:: The analysis of the MAUDE database disclosed certain device-related dysfunctions that have been under-reported in the published literature. Also, complications such as fragmentation, bone erosion and foreign body reaction have not been previously described. Awareness of these details will assist in decision-making and quality control. Due to the voluntary nature of reporting, the true incidence of each complication is unknown with the above data representing a baseline. Nonetheless, the MAUDE database serves as an illuminating source of information which would further be strengthened by a more robust and mandatory reporting of device-related complications. [Table: see text][Table: see text]
Arthroscopic Bone Marrow Stimulation for the Treatment of Osteochondral Lesions of the Talus Shows Promising Clinical Outcomes Over 10 Years
Authors: Park Jae Han , Lee Jin Woo , Park Kwang Hwan , Kim Sang B. , Park Yoo Jung , Han Seung Hwan 
Published: November 2020

Category: Arthroscopy; Ankle Introduction/Purpose: Arthroscopic bone marrow stimulation (BMS) has been considered as the 1st-line treatment for osteochondral lesions of the talus (OLT) with its simplicity, cost-effectiveness, low complication rate and successful clinical results in numerous studies. However, there were few studies which had investigated long-term clinical outcomes about the arthroscopic BMS. The purpose of this study is to evaluate the long-term outcomes of arthroscopic BMS for OLT and to identify prognostic factors that affect the outcomes. Methods: A retrospective analysis was performed for 202 ankles (189 patients) who underwent arthroscopic BMS as a primary surgery for the OLT between January 2001 and December 2008 with more than 10 years of follow-up. Visual analog scale (VAS) and American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot scales, Foot and Ankle Outcome Score (FAOS) were assessed as clinical outcomes and re-operation data were collected. The clinical scores were compared along the stream of time. Kaplan-Meier plot and log rank test showed survival outcomes of OLT in the long-term follow-up. Factors associated with revision surgery were evaluated with multivariate Cox proportional hazard regression model. Results: The VAS scales were improved from 7.11 +- 1.73 (preoperatively) to 1.51 +- 1.61 (3 to 6 years after BMS), and 2.00 +- 1.67 (over 10 years after BMS) (P < 0.001). Also the AOFAS ankle-hindfoot scale were also improved from 58.39 +- 13.7373 (preoperatively) to 85.85 +- 10.31 (3 to 6 years after BMS), and 82.56 +- 11.62 (over 10 years after BMS) (P < 0.001). FAOS at final follow-up was compatible with those of other literatures with short- and mid-term follow-up. Re-operation rate was 5.94 % (12 / 202 ankles). According to multivariate regression analysis, significant factors associated with the revision surgery were large- size (greater than 150mm2) OLT (P = 0.009) and body mass index greater than 25 kg/m2 (P = 0.014). Conclusion:: Arthroscopic bone marrow stimulation is an effective and reliable operative procedure for the primary treatment of osteochondral lesions of the talus with favorable long-term outcomes at a mean follow-up of 13.9 years. Therefore, we recommend this procedure for the 1st-line treatment of the OLT. Success of arthroscopic BMS depends on the size of the OLT and the body mass index of patients.