Development and reliability of a standard rating system for outcome measurement of foot and ankle disorders I: development of standard rating system

AbstractBackgroundThe aim of this study was to report the five scales comprising the rating system that the Japanese Society for Surgery of the Foot (JSSF) devised (JSSF standard rating system) and the newly offered interpretations and criteria for determinations of each assessment item.MethodsWe produced the new scales for the JSSF standard system by modifying the clinical rating systems established by the American Orthopaedic Foot and Ankle Society (AOFAS scales) and the Japanese Orthopaedic Association’s foot rating scale (JOA scale). We also provided interpretations of each assessment item and the criteria of determinations in the new standard system.ResultsWe improved the ambiguous expressions and content in the conventional standard rating systems so they would be easily understood by Japanese people. The result was five scales in total. Four were designed for use specifically for ankle-hindfoot, midfoot, hallux metatarsophalangeal- interphalangeal, and lesser metatarsophalangeal- ineterphalangeal sites; and the fifth was for the foot and ankle with rheumatoid arthritis. Furthermore, we described interpretations and criteria for determinations with regard to evaluation items in each scale.ConclusionsConventionally, the AOFAS scales or the JOA scale have been separately applied depending on the sites or disorders concerned, but it was often difficult to decide on scores during practical evaluations because of differing expressions in different languages and also because of ambiguity in the interpretation of each evaluation item and in scoring standards as well. JSSF improved these scales and added definite interpretations of evaluation items as well as criteria for the rating (to be reported here in part I). Because these steps were expected to improve the reliability of outcomes assessed by each scale, we examined the reliability in scores of the newly developed scales, which are reported in part II (in this issue)

Development and reliability of a standard rating system for outcome measurement of foot and ankle disorders II: interclinician and intraclinician reliability and validity of the newly established standard rating scales and Japanese Orthopaedic Association rating scale

AbstractBackgroundThis study evaluated the validity and inter- and intraclinician reliability of (1) the Japanese Society of Surgery of the Foot (JSSF) standard rating system for four sites [ankle- hindfoot (AH), midfoot (MF), hallux (HL), and lesser toe (LT)] and the rheumatoid arthritis (RA) foot and ankle scale and (2) the Japanese Orthopaedic Association’s foot rating scale (JOA scale).MethodsClinicians from the same institute independently evaluated participating patients from their institute by two evaluations at a 1- to 4-week interval. Statistical evaluation was as follows. (1) The intraclass correlation coefficient (ICC) was calculated from data collected from at least two examinations of each patient by at least two evaluating clinicians (Data A). (2) Total scores for the two evaluations were determined from the distribution of differences in data between the two evaluations (Data B); each item was evaluated by determining Cohen’s coefficient of agreement. (3) The relation between patient satisfaction and total score was investigated only for patients who underwent surgery (Data C). Spearman’s rank correlation coefficient was obtained.ResultsParticipants were 65 clinicians and 610 patients, including those with disorders of the AH (313), MF (47), HL (153), and LT (50) and those with RA (47). From Data A, the ICC was high for AH and HL by JSSF scales and for AH, MF, and LT by the JOA scale. From Data B, the coefficient showed high validity for both scales for AH, with almost no difference between the two scales; the validity for HL was higher with the JOA scale than with the JSSF scale. From Data C, correlations were significant between patient satisfaction and outcome for AH and HL by the JSSF scales and for AH, HL, and LT by the JOA scale.ConclusionsThe validity of both scales was high. Clinical evaluation of the therapeutic results using these scales would be highly reliable

The Predicting Factor for Avascular Necrosis After Talus Fracture — the Study Based on CT Findings

Category: Trauma Introduction/Purpose: Treatment of talus fracture is difficult. Because talus fracture often cause the avascular necrosis, and necessitate a prolonged non-weight-bearing period or arthrodesis in these cases. Identification of the fracture type that results in necrosis before a surgery may help in the determination of the planning of treatment and the prognosis. However, necrosis cannot be identified directly by a conventional fracture classification. We investigated the sites in which fracture lines of the talus are visible by using CT to determine the association between fracture of the talus and the occurrence of necrosis. Methods: Twenty-five patients (25 feet; 18 men and 7 women; mean age at the first visit, 48.4 years [range, 15–80 years]) treated through 2003 to 2013 were included in this study. Fracture lines were assessed using radiography and CT. According to the conventional classification, 12 neck fractures and 13 body fractures were found. The Inokuchi–Ogawa classification was used to assess the fracture line on the subtalar joint surfaces. A fracture line was defined as the line connecting 1 with the other point as follows: (a) the sulcus tali ; (b) the sinus tarsi; (c) between the lateral process and the lateral tubercle; and (d) the medial tubercle. MRI was used for the assessment of necrosis. The subjects were divided into the non-necrosis group (group A) and the necrosis group (group B), and relationship between fracture lines and appearance of necrosis was examined. Results: With the exclusion of 2 unclassifiable cases, group A consisted of 15 feet, whereas group B consisted of 8 feet. At the Inokuchi–Ogawa classification, 1fracture line was found in 8 feet,2:5, and and 3:1 in group A. In group B, all cases showed multiple fracture lines. Among the lines connecting a-b, a-c, and b-d, fracture was observed in more than 2 lines in the all cases . Conclusion: The most important factor for determining the prognosis of talus fracture is the presence or absence of necrosis. The results of this study indicate that fracture lines connecting a-b, a-c, and b-d interrupt major blood routes, and talus fracture more than 2 fracture lines were highly likely to develop avascular necrosis. Thus, fracture lines may predict the occurrence of necrosis and possible sites of its occurrence

Radiographic analysis of Hallux valgus. A study on foot arch by severity

Category: Bunion Introduction/Purpose: X-ray measurement for hallux valgus has been conducted with various results in the evaluation. However, it was not quite clarified yet and it still remains questionable why a mild case shifts to a severe case during the course. We report about the difference between the severity and the foot shape. Methods: The study subjects were 206 feet of 138 patients. Mild case: 80 feet, mean age 53 y.o (A) Moderate case: 61 feet, 62 y.o (B) Severe case: 65 feet, 67 y.o (C) For the examination items, HVA, M1-2 angle, and M1-5 angle were measured with the x-ray frontal radiograph for loading position, and First, Second, Fifth intermetatarsal angle (M1Y/M2Y/M5Y) on sagittal plane were also measured. We also evaluated the foot arch ratio with Yokokura Method, then compared/examined those results after dividing the cases into the mild, moderate, and severe group with age bracket. Results: The age of Group C were older than Group A, B. M1-2 angle: In younger generation, three is significant difference between Group A and B. M1-5 angle: Significant in 60 s between A and B. In 70 s, significant: all group. Navicular height: all group is low arch with aging. Significant between A and C It is becoming low arch at Lisfranc level with aging in all group. There is significantly low height at M5 with aging in all group. On sagittal plane, bone axis of M1 and M2 is lowered at 40 s in Group A and B and 70 s in Group C. Conclusion: In hallux valgus, the foot shape was changed in coronal and sagittal plane. It means the collapse of bone structure at foot and ankle. It may possibly be shifting to a severe case with aging. However, we could not find any result definitely suggesting such condition

Phase I/II clinical trial of nivolumab in combination with oligo-fractionated irradiation for unresectable advanced or recurrent gastric cancer

Abstract Background Although immune checkpoint inhibitors (ICI) targeting for PD-1 axis is a promising approach for advanced gastric cancer (GC) patients, the response rate is still limited. Induction of synergistic effect of irradiation with ICI targeting for the PD-1 axis can be an attractive strategy. The aim of this study was to assess the effect of the combination of irradiation with anti-PD-1 therapy for advanced GC. Methods We conducted a single-arm, phase I/II trial in GC patients treated with a combination of nivolumab and oligo-fractionated irradiation (22.5 Gy/5 fractions/5 days) (NCT03453164). Eligible patients (n = 40) had unresectable advanced or recurrent GC which progressed after primary and secondary chemotherapy with more than one lesion. The primary endpoint is the disease control rate (DCR) of non-irradiated target lesions and the secondary endpoints are the median survival time (MST), safety, and DCR of irradiated lesions. Results We observe that the DCR for the non-irradiated target as the abscopal effect is 22.5% (90% confidence interval (CI), 12.3–36.0), and the DCR for the irradiated lesion is 40.0% (90% CI, 26.9–54.2). The median survival time is 230 days (95% CI, 157–330), and grade 3 and higher adverse events (AEs) are observed in 16 patients (39 %) with no obvious additional AEs when adding irradiation. Conclusions The present study suggests that the combination of nivolumab with oligo-fractionated irradiation has the potential to induce a promising anti-tumor effect for advanced GC