scholarly journals Comparison of Clinical Outcomes after Arthroscopic Anterior Talofibular Ligament Repair with or without Inferior Extensor Retinaculum Augmentation

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0032
Author(s):  
Sung Hyun Lee
Keyword(s):  
Clinical Outcomes ◽  
Anterior Talofibular Ligament ◽  
Extensor Retinaculum ◽  
Lateral Instability ◽  
Aofas Score ◽  
Sports Activity ◽  
Activity Unit ◽  
Group A ◽  
Inferior Extensor Retinaculum

Category: Sports; Arthroscopy Introduction/Purpose: Though several arthroscopic surgical techniques for the treatment of lateral instability of the ankle have been introduced recently; the effect for the inferior extensor retinaculum augmentation is remained unclear. The purpose of this study was to compare the clinical outcomes after arthroscopic anterior talofibular ligament (ATFL) repair with or without additional retinaculum augmentation. Methods: We performed a retrospective review between 2017 and 2018 of 61 consecutive patients who underwent arthroscopic ATFL repair surgery for chronic ankle lateral instability. The exclusion criteria were previous surgery on affected ankle and combined medial ligament instability. Demographic data were evaluated including age, gender, smoking, Body mass index, generalized hyperlaxity and concomitant lesions. Patients were divided into two groups according to whether retinaculum repair or not. Clinical results were analysed to compare groups A and R preoperatively and at minimum follow-up of 1 years by using the Visual Analogue Scale, American Orthopaedic Foot & Ankle Society (AOFAS) score, Foot and Ankle Outcome score (FAOS), and Karlsson Ankle Functional Score. Radiologic outcome evaluations were performed preoperatively and at 2 year postoperatively at final follow-up using anterior talar translation, and talar tilt angle. Results: A total of 62 patients were included in this study. Patients were divided into two groups: group A consisted of 29 patients who underwent only arthroscopic ATFL repair and group R consisted of 32 patients who underwent arthroscopic ATFL repair and additional retinaculum augmentation. There was no difference statistically between two group in demographics (Table 1). All clinical scores were improved after surgery in both groups. (P<0.001) There were no differences were found in VAS, AOFAS score, total FAOS and Karlsson score between two groups. However, sports activity unit in FAOS, there were significant differences between group A (71.4 +- 8.1) and group R (83.4 +- 8.6) (Table 2). (p=0.032) Radiographic data also showed no differences (Table 3). Conclusion: Arthroscopic ATFL repair achieved improved outcomes postoperatively with or without retinaculum augmentation. However, among physically active patients with chronic ankle lateral instability, arthroscopic ATFL repair with retinaculum augmentation results in better sports activity unit in FAOS as compare with arthroscopic ATFL repair alone.

Additional Inferior Extensor Retinaculum Augmentation After All-Inside Arthroscopic Anterior Talofibular Ligament Repair for Chronic Ankle Instability Is Not Necessary

2021 ◽  
pp. 036354652110080
Author(s):  
Sung Hyun Lee ◽  
Hyung Gyu Cho ◽  
Je Heon Yang
Keyword(s):  
Clinical Outcomes ◽  
Ankle Instability ◽  
Surgical Techniques ◽  
Chronic Ankle Instability ◽  
Anterior Talofibular Ligament ◽  
Extensor Retinaculum ◽  
Level Of Evidence ◽  
Group A ◽  
The Mean ◽  
Inferior Extensor Retinaculum

Background: Although several arthroscopic surgical techniques for the treatment of chronic ankle instability (CAI) have been introduced recently, the effect of inferior extensor retinaculum (IER) augmentation remains unclear. Purpose: To compare the clinical outcomes after arthroscopic anterior talofibular ligament (ATFL) repair according to whether additional IER augmentation was performed or not. Study Design: Cohort study; Level of evidence, 3. Methods: We performed a retrospective review of consecutive patients who underwent arthroscopic ATFL repair surgery for CAI between 2016 and 2018. The mean age of the patients was 35.2 years (range, 19-51 years), and the mean follow-up period was 32.6 months (range, 24-48 months). Patients were divided into 2 groups according to the surgical technique used for CAI: arthroscopic ATFL repair (group A; n = 37) and arthroscopic ATFL repair with additional IER augmentation (group R; n = 45). The pain visual analog scale, American Orthopaedic Foot & Ankle Society score, Foot and Ankle Outcome Score, and the Karlsson Ankle Function Score were measured as subjective outcomes, and posturographic analysis was performed using a Tetrax device as an objective outcome. Radiologic outcome evaluations were performed preoperatively and at 2 years postoperatively using stress radiographs and axial view magnetic resonance imaging (MRI). Results: Out of 101 patients, 19 (18.5%) were excluded per the exclusion criteria, and 82 were evaluated. We identified 6 retears (7.3%) based on postoperative MRI evaluation. All patients who had ATFL retear on MRI (8.1% [3/37] in group A and 6.7% [3/45] in group R) demonstrated recurrent CAI with functional discomfort and anterior displacement >3 mm as compared with the intact contralateral ankle. All clinical scores and posturography results were improved after surgery in both groups ( P < .001). However, there were no significant differences in the clinical results and radiologic findings between the groups. Conclusion: The clinical and radiologic outcomes of patients with CAI improved after all-inside arthroscopic ATFL repair. However, additional IER augmentation after arthroscopic ATFL repair did not guarantee better clinical outcomes.

scholarly journals Minimally Invasive Reconstruction of Anterior Talofibular Ligament with Partial Peroneus Brevis Tendon in the Treatment of Chronic Lateral Ankle Instability

2014 ◽  
Vol 1 (1) ◽  
pp. 12-16
Author(s):  
Qian-bo Chen ◽  
Xiao-kang Tan ◽  
Chen-song Yuan ◽  
Xu Tao ◽  
Hong-hui Cao ◽  
...  
Keyword(s):  
Minimally Invasive ◽  
Clinical Outcomes ◽  
Ankle Instability ◽  
Asia Pacific ◽  
Anterior Talofibular Ligament ◽  
Lateral Ankle ◽  
Chronic Lateral Ankle Instability ◽  
Lateral Ankle Instability ◽  
Peroneus Brevis

ABSTRACT Background Chronic lateral ankle instability causes significant problems in physical activity and accelerates development of osteoarthritic changes. Many procedures were designed to reconstruct the anterior talo-fibular ligament (ATFL) in the treatment of chronic lateral ankle instability. Although most of them were effective, but brought big trauma and sacrifice of some tendons. Objective To design a minimally invasive ATFL reconstruction with partial peroneus brevis tendon and evaluate its clinical outcomes. Study design Nonrandomized controlled clinical trial. Materials and methods From 2004 to 2012, 29 patients of chronic lateral ankle instability were treated with minimally invasive ATFL reconstruction with partial peroneus brevis tendon. A 3 cm curved incision was made to explore the ATFL origin and its insertion. Half peroneus brevis tendon was taken to reconstruct the ATFL through the bone tunnel from the insertion of CFL to the insertion of ATFL in the fibular, and then fixed to ATFL insertion location on the talus. All patients were followed-up by radiology and clinical examination at least two years. Their ATFLs were always evaluated by standard stress X-ray examination and magnetic resonance imaging (MRI) prior to surgery and every 1 year after the operation. Functional results were assessed in terms of Karlsson score and the American Orthopaedic Foot and Ankle Society (AOFAS) anklehind foot score. Results The average follow-up period was 57.9 months (24- 114 months). The majority of results (93.1%) were satisfactory. The mean Karlsson score improved from 41.7 prior to surgery to 88.6 and AOFAS from an average 47.2 preoperatively to 91.7 postoperatively at the final follow-up visit. Paired t-tests showed improvements of great significance (p < 0.01). The ligaments were proved be reconstructed well in all patients by MRI. It showed the negative talar tilt sign postoperatively by stress X-rays. There was no recurrence of lateral ankle instability. Conclusion The minimally invasive ATFL reconstruction with partial peroneus brevis tendon has advantages of small trauma, good reconstruction and excellent clinical outcomes, thus, is a safe and effective method for the treatment of chronic lateral ankle instability. How to cite this article Chen Q, Tan X, Yuan C, Tao X, Cao H, Xu J, Tang K. Minimally Invasive Reconstruction of Anterior Talofibular Ligament with Partial Peroneus Brevis Tendon in the Treatment of Chronic Lateral Ankle Instability. J Foot Ankle Surg (Asia-Pacific) 2014;1(1):12-16.

Comparison of virtual visit versus traditional clinic for management of varicose veins

2018 ◽  
Vol 26 (1-2) ◽  
pp. 100-104 ◽  
Author(s):  
Judith C Lin ◽  
Dylan Mclaughlin ◽  
Dana Zurawski ◽  
Nicole Kennedy ◽  
Loay Kabbani
Keyword(s):  
Clinical Outcomes ◽  
Varicose Vein ◽  
Varicose Veins ◽  
Statistical Testing ◽  
Categorical Variables ◽  
Venous Disease ◽  
Group A ◽  
Group B ◽  
Clinic Group

Introduction The objective of this study is to compare the clinical outcomes of patients with varicose veins managed in the telemedicine clinic and traditional clinic. Methods Retrospective analysis of all vein procedures in the institutional Vascular Quality Initiative Varicose Vein Registry (VQI VVR) was performed from January 2015 to August 2017. Patients were divided into two groups: Telemedicine versus Traditional Clinic. Comparison data included patient demographics, past medical history, clinical outcomes, patient-reported outcomes and postoperative complications. Statistical testing included chi-square test for categorical variables and student t-test for continuous variables using the SPSS statistical software. Results A total of 1034 varicose vein procedures were performed during the 31-month study period. There were 75 virtual encounters in the Telemedicine Clinic (Group A) and 959 face-to-face encounters in the Traditional Clinic (Group B). Most of the demographics characteristics were clinically similar in both groups. Comparing Group A and Group B, there were no differences in age, sex, race and body mass index. Early 3-month follow up was 100% in Group A and 90.7% in Group B. Both groups had low complication rates of haematoma (1.3% vs 0.3%, p = 0.884), paraesthesia (1.3% vs 0.6%, p = 0.767) and recanalisation (1.3% vs 4.0%, p = 0.383) during the early follow up period. Discussion Synchronous virtual visits for patient care are feasible for the management of chronic venous disease. Patients with varicose veins who choose to undergo telemedicine evaluations have similar pre-operative demographics, clinical classification and patient outcomes.

Lower Signal Intensity of the Anterior Talofibular Ligament is Associated with a Higher Rate of Return to Sport After ATFL Repair for Chronic Lateral Ankle Instability

2019 ◽  
Vol 47 (10) ◽  
pp. 2380-2385 ◽  
Author(s):  
Hong Li ◽  
Yinghui Hua ◽  
Sijia Feng ◽  
Hongyun Li ◽  
Shiyi Chen
Keyword(s):  
Signal Intensity ◽  
Functional Outcomes ◽  
Ankle Instability ◽  
Return To Sport ◽  
Rate Of Return ◽  
Anterior Talofibular Ligament ◽  
Aofas Score ◽  
Significant Difference ◽  
The Mean

Background: The treatment strategy for anterior talofibular ligament (ATFL) injury is usually determined by the ATFL remnant condition during surgery. Preoperative magnetic resonance imaging (MRI)–based signal intensity of the ATFL remnant, represented by the signal/noise ratio (SNR) value, can reveal the ATFL remnant condition. Thus far, there is a lack of evidence regarding the relationship between the ATFL remnant condition and functional outcomes. Purpose/Hypothesis: The purpose was to quantitatively evaluate whether the MRI-based ATFL ligament SNR value is related to functional outcomes after ATFL repair for ankles with chronic lateral ankle instability. The hypothesis was that a lower preoperative SNR is related to a better clinical outcome, particularly a higher rate of return to sport. Study Design: Cohort study; Level of evidence, 3. Methods: First, a preliminary study was performed to measure the ATFL SNR in preoperative MRI, the results of which suggested that a preoperative SNR >10.4 was indicative of a poor ATFL condition. Then, a cohort study was retrospectively performed with consecutive patients who underwent open repair of ATFL injuries between January 2009 and August 2014. Accordingly, the patients were divided into 2 groups: high SNR (HSNR; ≥10.4) and low SNR (LSNR; <10.4). Functional outcomes based on the American Orthopaedic Foot and Ankle Society (AOFAS) score, Karlsson Ankle Functional Score (KAFS), and Tegner Activity Scale were then compared between the HSNR group and the LSNR group. Results: Ultimately, 70 patients were available for the final follow-up: 37 in the HSNR group and 33 in the LSNR group. No significant difference was detected between the HSNR group and the LSNR group in terms of the AOFAS score, KAFS, or Tegner Activity Scale ( P > .05 for all) preoperatively. At the final follow-up, the mean ± SD AOFAS score in the LSNR group (92 ± 6) was higher than that in the HSNR group (87 ± 12), although no significant difference was detected postoperatively ( P = .16). The mean KAFS in the LSNR group (94 ± 7) was significantly higher than that in the HSNR group (88 ± 11) postoperatively ( P = .03). At follow-up, the mean Tegner score in the LSNR group (6; range, 3-7) was significantly higher than that in the HSNR group (5; range, 1-8) postoperatively ( P = .03). Patients in the LSNR group had a significantly higher percentage of sports participation than those in the HSNR group (91% vs 65%, P = .02) postoperatively. Conclusion: A lower signal intensity in the ATFL ligament based on preoperative MRI is associated with a better clinical outcome, particularly a higher rate of return to sport.

scholarly journals Long-term Survival and Clinical Outcomes of Non-vascularized Autologous and Allogeneic Fibular Grafts are Comparable for Treating Osteonecrosis of the Femoral Head

2020 ◽  
Author(s):  
Ke Jie ◽  
Wenjun Feng ◽  
Feilong Li ◽  
Keliang Wu ◽  
Jinlun Chen ◽  
...  
Keyword(s):  
Survival Rate ◽  
Femoral Head ◽  
Clinical Outcomes ◽  
Harris Hip Score ◽  
Fibular Graft ◽  
Vas Score ◽  
Long Term Follow Up ◽  
Group A

Abstract Background Osteonecrosis of the femoral head (ONFH) is a disabling disease, which often involves young patents. Recently, various hip-preserving surgeries were recommended to delay total hip arthroplasty (THA).Questions/purposes This study aimed to compare clinical outcomes and survival rate in the long-term follow-up between core decompression combined with a non-vascularized autologous fibular graft (group A) and an allogeneic fibular graft (group B) for the treatment of ONFH.Patients and Methods We retrospectively evaluated 117 patients (153 hips) with ONFH (Association Research Circulation Osseous [ARCO] stages IIa to IIIc) who underwent the above-mentioned hip-preserving surgeries between January 2003 and June 2012. The mean (range) follow-up times (years) were 12.9 (7–16) and 9.3 (6–16) in groups A and B, respectively. Clinical outcomes were assessed using the Harris hip score (HHS), visual analog scale (VAS) score, forgotten joint score (FJS). A survival analysis was performed using the Kaplan-Meier method. The end point was THA.Results Groups A and B showed postoperative improvements, respectively, in HHS from 65±7.2 to 80.3±14.5 and from 66±5.9 to 82.4±13.6 (p<0.05), and in VAS score from 6.3±1.1 to 2.3±1.6 and from 6.1±1 to 2.2±2.2 (p<0.05). However, no significant differences in the HHS, VAS score, and hip FJS at the last follow-up (p>0.05) and 15-year survival rate (84.1% and 86%, respectively, p>0.05) were found between group A and B.Conclusions Autologous and allogeneic fibular grafts can attain equally good clinical outcomes and high survival rates in long-term follow-up, and thus can greatly delay THA owing to good bone osseointegration and sufficient mechanical support. Notably, the ratio of failure will increase when patients were more than 37 years old.Level of Evidence Level III, therapeutic study.

Reconstruction of the Lateral Ankle Ligaments Using an Inferior Extensor Retinaculum Flap

1997 ◽  
Vol 18 (11) ◽  
pp. 723-728 ◽  
Author(s):  
D. Saragaglia ◽  
F. Fontanel ◽  
E. Montbarbon ◽  
Y. Tourné ◽  
F. Picard ◽  
...  
Keyword(s):  
Ankle Instability ◽  
Chronic Ankle Instability ◽  
X Rays ◽  
Extensor Retinaculum ◽  
Sports Activity ◽  
Ankle Ligaments ◽  
Lateral Ankle ◽  
Functional Instability ◽  
Lateral Ankle Ligaments ◽  
Inferior Extensor Retinaculum

The aim of this study was to assess the results of 32 cases of chronic ankle instability. These were treated by ligament shortening and reinforced with an inferior extensor retinaculum flap. All patients complained of persistent functional instability unrelieved with proprioceptive exercises. Results were assessed clinically (pain, instability, recovery of sports activity, mobility) and radiologically (correction of laxity on stress x-rays). This enabled us to draw up a revision score on a scale of 100 points. We obtained a mean score of 86.7 points (45–100 points), and subjective results showed that 88% of the patients were satisfied with the surgery.

scholarly journals Survivorship and Long-term Results of Consecutive Series of 118 Hintegra Total Ankle Arthroplasties

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0033
Author(s):  
Jae Han Park ◽  
Yeok Gu Hwang ◽  
Jae Bum Kwon ◽  
Dong Woo Shim ◽  
Kwang Hwan Park ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Mobile Bearing ◽  
Total Ankle Arthroplasty ◽  
Long Term Outcomes ◽  
Metal Component ◽  
Aofas Score ◽  
Ankle Arthroplasty ◽  
The Mean

Category: Ankle Arthritis Introduction/Purpose: Total ankle arthroplasty (TAA) has been more suggested to patients with end-stage ankle osteoarthritis. However, there were few studies which had investigated long-term clinical outcomes with mobile bearing system. The purpose of this study is to evaluate the long-term outcomes of total ankle arthroplasty with use of the Hintegra prosthesis and to identify prognostic factors that affect the outcome. Methods: Between September 2004 and December 2009, 118 ankles underwent total ankle arthroplasty with Hintegra prosthesis. Clinical outcomes were assessed annually after operation using visual analog scale (VAS), American Orthopaedic Foot & Ankle Society (AOFAS) scores, plain radiographs and re-operation. Kaplan-Meier survival plot showed survival outcomes of TAA in long-term follow-up. Results: The mean follow-up period was 10.9 years (range 9.0-14.3). The mean change from baseline to final follow-up was -6.7 ± 4.3 points for VAS, and 26.1 ± 10.3 points for the AOFAS score. Three (2.5%) of the ankles required metal component revision at a mean of 2.9 ± 1.8 years (range, 0.5 to 5.8 years) after primary surgery. Five (4.2%) ankles underwent conversion to arthrodesis. Cystic osteolysis that needed surgery was 19 (16.1%) cases, most frequent lesion was posterior aspect of distal tibia. 65 ankles (55.1%) showed heterotopic ossifications but the degree of heterotopic ossification was not significantly correlated with VAS and AOFAS score. Revision with metal component as the end point of prosthesis was 86% at 10 years of follow up. Conclusion: Long term outcomes were satisfactory after mobile-bearing total ankle arthroplasty. Further study to elucidate possible reasons for osteolysis and subjective pain after TAA is warranted.

scholarly journals Primary vs Secondary Osteochondral Autograft Transplantation in Patients with Large Sized OLT

2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0000
Author(s):  
Kwang Hwan Park ◽  
Yeokgu Hwang ◽  
Yoo Jung Park ◽  
Dong-Woo Shim ◽  
Jin Woo Lee
Keyword(s):  
Clinical Outcomes ◽  
Bivariate Analysis ◽  
Clinical Failure ◽  
Aofas Score ◽  
Marrow Stimulation ◽  
Kaplan Meier ◽  
Operation Rate ◽  
Significant Difference ◽  
The Mean

Category: Ankle, Arthroscopy, Sports Introduction/Purpose: Osteochondral autograft transplantation (OAT) for large sized osteochondral lesions of the talus (OLT) has presented promising clinical results in recent studies. However, there was no study which has compared clinical outcomes between primary OAT and secondary OAT in the large sized OLT. The purpose of this study is to compare clinical outcomes between patients receiving primary transplantation and patients receiving secondary transplantation after failure of previous marrow stimulation for large sized OLT and investigate prognostic factor affecting clinical failures. Methods: Between 2005 and 2014, 18 patients with large sized OLT (=150 mm2) underwent primary OAT as a primary surgery (primary group) and 28 patients with large sized OLT underwent secondary OAT after a failure of arthroscopic marrow stimulation (secondary group). After arthroscopic inspection and debridement for concomitant soft tissue pathologies, conventional OAT procedures were performed. Clinical outcomes were assessed using visual analog scale (VAS), American Orthopaedic Foot & Ankle Society (AOFAS) scores, Foot and Ankle Outcome Score (FAOS) and re-operation rate. Factors associated with clinical failure were evaluated using bivariate analysis and logistic regression analysis. Survival outcomes were compared using Kaplan-Meier analysis. Results: The mean follow-up time was 6.0 years (range 2.0-10.8) and the mean size of the lesion was 194.9 mm2 (range 151.7- 296.3). There was no significant difference in patients` demographics, and preoperative findings between primary and secondary groups. Postoperative VAS, AOFAS score, FAOS, and re-operation rate had no significant difference between primary and secondary groups at the last follow-up. According to bivariate analysis, significant factor associated with clinical failure was not prior marrow stimulation but more than 225 mm2 of lesion size in preoperative MRI. Logistic regression analysis revealed that preoperative AOFAS score was significant predictor of clinical failure after the OAT in this study. The survival probabilities were not significantly different between primary and secondary groups in Kaplan-Meier plots (P = .947). Conclusion: Outcomes of secondary OAT were comparable to those of primary OAT in the large sized OLT. Therefore, we suggested that symptomatic patients with large sized OLT could be initially treated by either arthroscopic marrow stimulation or OAT and if failed with marrow stimulation, secondary OAT could be considered.

scholarly journals Clinical Outcomes for Isolated Subscapularis Tears With Advanced Fatty Infiltration: Nonoperative Treatment Versus Arthroscopic Single-Row Repair

2021 ◽  
Vol 9 (2) ◽  
pp. 232596712097575
Author(s):  
Tae-Hwan Yoon ◽  
Sung-Jae Kim ◽  
Yun-Rak Choi ◽  
Ho-Sung Keum ◽  
Yong-Min Chun
Keyword(s):  
Clinical Outcomes ◽  
Operative Treatment ◽  
Fatty Infiltration ◽  
Supraspinatus Tendon ◽  
Significant Difference ◽  
Group A ◽  
Grade 3 ◽  
Group B ◽  
Retear Rate

Background: No study has investigated the treatment outcomes of isolated subscapularis tears with advanced fatty infiltration and tear progression to the supraspinatus tendon. Purpose: To assess the natural progression of isolated subscapularis tears with advanced fatty infiltration and compare clinical outcomes between nonoperative and operative treatment. Study Design: Cohort study; Level of evidence, 3. Methods: This study included 52 patients who received either operative (group A) or nonoperative (group B) treatment at our institution for isolated subscapularis full-thickness tears with grade 3 or 4 advanced fatty infiltration. All study patients had a minimum 2-year follow-up. The following 4 functional measures were used: visual analog scale for pain, Subjective Shoulder Value, American Shoulder and Elbow Surgeons score, and University of California Los Angeles score. The modified belly-press test was used to assess subscapularis muscle strength. In group A, structural integrity was evaluated using magnetic resonance imaging at 6 months after surgery. In addition, ultrasonographic evaluation was performed on both groups during the follow-up period to assess tear progression into the supraspinatus tendon. Results: At initial presentation, all functional assessment scores were significantly worse in group A versus group B ( P ≤ .05 for all 4 scores). When we compared the mean change in scores before treatment versus after treatment, the group A patients were found to have significantly greater improvement than group B patients ( P < .001 for all 4 scores); however, no significant difference was seen in final outcome scores between the groups. Although a high retear rate of 78.6% (22/28) was identified in group A, both groups showed no further tear progression to the supraspinatus tendon at the final ultrasonographic evaluation. Conclusion: For isolated subscapularis tears with advanced fatty infiltration, clinical improvement was seen with both nonoperative and operative treatment. Although the operatively treated group started with lower baseline scores, there were no significant differences in outcomes at final follow-up. Considering the high retear rate even after repair, surgical treatment of these lesions may not be warranted. Early detection and prompt repair of subscapularis tears, before the lesion becomes advanced with grade 3 or 4 fatty infiltration, are important for better outcomes.

scholarly journals Comparison of clinical outcomes of sitagliptin+metformin combination and glimepiride in the management of uncomplicated type 2 diabetics

2018 ◽  
Vol 8 (1) ◽  
pp. 16
Author(s):  
Jarinabanu Tahashildar ◽  
Ravi Shekhar Singh ◽  
Jameela Tahashildar
Keyword(s):  
Adverse Events ◽  
Clinical Outcomes ◽  
Diabetic Patients ◽  
Open Label ◽  
Type 2 Diabetics ◽  
Significant Difference ◽  
Group A ◽  
Group B

Background: To evaluate the comparison of clinical outcomes of sitagliptin +metformin and glimepride in uncomplicated Type-2 diabetics.Methods: This one year (July 2016 to August 2017) prospective, open label, observational clinical cohort study was carried out on type-2 diabetics. In this study 299 Type-2 diabetics patients were enrolled and were randomly allocated to two groups viz Group A and Group B. Group A received sitaglitin+metformin (50+500) mg/day and Group B received glimepride 1mg/day respectively. The follow up started after 10 days of stabilization of the patient and data recorded on 10th day was considered Zero month data and follow up continued up to Six month in each group. Comparison of FPG, PPG and HbA1c was evaluated between zero and six months within group and at six month between groups. Adverse events were recorded and summarized by treatment group.Results: At the end of six months follow up the patients of Group A who received sitaglitin+metformin (50+500) mg/day had greater reduction in FPG, PPG and HbA1c (all P<0.001) was recorded when compared between zero and six month within group. A significant reduction in FPG, PPG and HbA1c (all P<0.01) also recorded in Group B who received glimepride 1mg/day when compared between zero and six months within group. A statically significant difference (all P<0.05) was recorded at six months between group. The adverse events like hypoglycemic episodes, gastrointestinal adverse events etc were greater in Group B than Group A. Changes in weight also noted in both Groups. Weight loss in Group A and weight gain in Group B was recorded.Conclusions: The present study suggests that a significant difference may be existing in the clinical outcome interm of glycemia control and adverse events between sitagliptin+metformin combination and glimepride in type-2 diabetic patients.

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