scholarly journals Simultaneous Bilateral Femoral and Tibial Lengthening in Achondroplasia

Children ◽  
2021 ◽  
Vol 8 (9) ◽  
pp. 749
Author(s):  
Lior Shabtai ◽  
Julio J. Jauregui ◽  
John E. Herzenberg ◽  
Martin G. Gesheff ◽  
Shawn C. Standard ◽  
...  
Keyword(s):  
Adverse Events ◽  
Medical Records ◽  
Soft Tissues ◽  
Mechanical Axis ◽  
Duration Of Treatment ◽  
Mechanical Axis Deviation ◽  
Tibial Lengthening ◽  
Femoral Lengthening ◽  
End Of Treatment

Previous studies on lengthening for achondroplasia have reported bilateral extensive femoral lengthening followed by bilateral extensive tibial lengthening. To decrease trauma on soft tissues and joints, we propose bilateral simultaneous moderate femoral lengthening and moderate tibial lengthening followed by a similar repeat lengthening a few years later. Fifty patients with achondroplasia underwent 65 simultaneous bilateral femoral and tibial lengthening procedures. Segment lengthening amount and adverse events were obtained from medical records. Mean follow-up after bone healing was 35.6 months. Mean tibial lengthening was 52 mm; mean femoral lengthening was 72 mm. Average healing index was 1.4 months/cm for the tibia and 1 month/cm for the femur. Mean duration of treatment with external fixation was 6.7 months (range, 4.4–10.5 months). Thirty-eight (76%) of 50 patients experienced one or more adverse events during lengthening. We observed 78 adverse events, 35 (45%) of which required additional surgical procedures. All resolved by the end of treatment. Mechanical axis deviation improved from a mean of 15 mm medially to 8 mm medially. Simultaneous lengthening of four segments in patients with achondroplasia is a feasible strategy. Compared with isolated femoral or tibial lengthening, distributing the lengthening between the femur and tibia decreases total external fixator time.

scholarly journals Long-term follow-up results of medial opening wedge high tibia osteotomy with a pre-countered non-locking steel plate

2021 ◽  
Author(s):  
Simo S. A. Miettinen ◽  
Hannu J. A. Miettinen ◽  
Jussi Jalkanen ◽  
Antti Joukainen ◽  
Heikki Kröger
Keyword(s):  
Risk Factors ◽  
Adverse Events ◽  
Mechanical Axis ◽  
Steel Plate ◽  
Cox Regression ◽  
Opening Wedge ◽  
Cumulative Survival ◽  
Long Term Follow Up

Abstract Introduction This retrospective study investigated the long-term follow-up results of medial opening wedge high tibial osteotomy (MOWHTO) with a pre-countered non-locking steel plate implant (Puddu plate = PP) used for medial knee osteoarthrosis (OA) treatment. Materials and methods Consecutive 70 MOWHTOs (66 patients) were performed between 01.01.2004 and 31.12.2008 with the mean follow-up time of 11.4 (SD 4.5; range 1.2–16.1) years. The Kaplan–Meier survival analysis was used to evaluate the cumulative survival of the implant in terms of age (< 50 years old and ≥ 50 years old) and gender. Adverse events were studied and Cox regression analysis was used to evaluate risk factors [age, gender, body mass index (BMI), preoperative mechanical axis, severity of OA, use of bone grafting or substitution and undercorrection of mechanical axis from varus to valgus] for revisions. Results The estimates for the cumulative survival with no need for TKA after MOWHTO were 86% at 5 years, 67% at 10 years and 58% at 16.1 years (SE 0.6, CI 95% 11.1–13.5). A total of 33/70 (47%) adverse events occurred and 38/70 (54%) knees required some revision surgery during the follow-up. Cox regression did not show any statistically significant risk factors for revision. Conclusions The PP has feasible MOWHTO results with a cumulative survival of 67% at 10 years with no need for conversion to TKA. Many adverse events occurred and revision rate due to any reason was high. Age or gender did not have statistically significant differences in terms of survival.

Microcannula Utilization for Injectable Facial Fillers: Standard of Care?

2018 ◽  
Vol 35 (4) ◽  
pp. 189-197 ◽  
Author(s):  
Kian Karimi ◽  
Chester F. Griffiths ◽  
Alex Reivitis ◽  
Austin Davis-Hunter ◽  
Elizabeth Zhang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Electronic Medical Records ◽  
Medical Records ◽  
Standard Of Care ◽  
Dermal Filler ◽  
Popular Method ◽  
Patient Reported ◽  
Clinical Series ◽  
Filler Injections

The microcannula technique has become an increasingly popular method for injecting cosmetic fillers. Previous studies have illustrated that the microcannula technique allows filler to be injected with less pain, swelling, and essentially no bruising. This study is a retrospective clinical series examining 247 patients who have undergone dermal filler injections using the microcannula technique from 2011 to 2016 with a single injector, Kian Karimi. The purpose of this study is to assess the frequency of adverse events associated with injections such as bruising and swelling. All 666 recorded patient visits from 2011 to 2016 were analyzed using electronic medical records based on the criteria that the patients had cosmetic filler using the microcannula technique by the surgeon investigator. Of the 666 filler treatments using the microcannula technique, 3 treatments (0.5%) produced adverse events on the day of service, and 32 treatments (4.8%) produced adverse events at 2-week follow-up. In total, 5.4% of treatments produced adverse events. At the 2-week follow-up, 5.7% of treatments using the 25-gauge microcannula produced adverse events ( P = .830); 3.9% of treatments using the 27-gauge microcannula produced adverse events ( P = .612]). Only 3 patients were treated with the 30-gauge microcannula, and 1 patient reported adverse events on the day of service. None of the treatments using the 30-gauge microcannula produced adverse events at the 2-week follow-up ( P = .160). The data support that the microcannula technique is a safe and effective alternative to hypodermic needles for the injection of dermal filler to minimize common adverse events.

Safety and tolerability of prescribed usage of Derise® (Darbepoetin Alfa, Hetero) in symptomatic anemia: A Post Marketing Surveillance Study

2020 ◽  
Author(s):  
Shubhadeep Sinha ◽  
Vamsi Krishna Bandi ◽  
Bala Reddy Bheemareddy ◽  
Pankaj Thakur ◽  
Sreenivasa Chary ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Adverse Events ◽  
Darbepoetin Alfa ◽  
P Value ◽  
End Of Treatment ◽  
Post Marketing Surveillance ◽  
Post Marketing

Abstract Background This post marketing surveillance, observational, prospective, safety study evaluated the safety, tolerability and long term immunogenicity of prescribed usage of Darbepoetin alfa, (DA-α, manufactured by Hetero Biopharma) in Indian patients with chronic kidney disease with anemia.Methods All patients with anemia of chronic kidney disease prescribed Hetero-Darbepoetin were the target patient population. The present study gathered the data from 503 Hetero-Darbepoetin alfa prescribed patients. This study collected information of patient demography, patient's medical history, concomitant medications, action taken with respect to Hetero-Darbepoetin-alfa, AE details (AE term, start date, stop date, severity, action taken, outcome and causality), periodic Hemoglobin (Hb) levels and abnormal laboratory tests results until treatment is discontinued or the patient is lost to follow-up. Immunogenicity data was collected in 121 patients at the end of treatment and after 1 year. Statistical analyses were performed to explore and analyze details of individual case safety reports of adverse events such as incidence, severity, seriousness, outcome, duration, action taken, and causality relationship of individual adverse event (AE) to the prescribed study drug. Results 87 AEs were reported in this study and most of them were mild to moderate in intensity. No deaths or serious adverse events (SAEs) were reported in this study. Anti-drug antibodies were not detected in any subject at the end of treatment phase and after 12 months long term follow up period. Baseline mean Hemoglobin value was 8.34 (SD 1.24) g/dL and last visit mean Hemoglobin value was 10.42 (SD 1.28) g/dL. The mean difference between baseline and last visit was 2.10 [2.00, 2.20], statistically significant (p-value <.0001). Conclusions The safety and tolerability of the usage of DA-α (manufactured by Hetero Biopharma) is similar to that reported in the published literature of the innovator. No patients showed anti-drug antibodies after treatment. Additionally, the patients also showed significant improvement in hemoglobin levels, compared to baseline.Clinical Trial Registry Number: CTRI/2017/04/008338 [Registered on CTRI http://ctri.nic.in/Clinicaltrials/login.php : 12/04/2017]; Trial Registered Retrospectively

Mitoxantrone treatment in patients with early relapsing-remitting multiple sclerosis

2007 ◽  
Vol 13 (8) ◽  
pp. 975-980 ◽  
Author(s):  
E. Cocco ◽  
P. Marchi ◽  
C. Sardu ◽  
P. Russo ◽  
A. Paolillo ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Relapse Rate ◽  
Serious Adverse Events ◽  
T2 Lesions ◽  
End Of Treatment ◽  
Relapsing Remitting ◽  
Annualized Relapse Rate ◽  
Relapsing Remitting Multiple Sclerosis

We investigated the clinical and MRI effects of mitoxantrone (MITOX) administered to 45 patients during the first five years of highly active relapsing-remitting multiple sclerosis. Differences occurring between the end of treatment and follow-up (clinical mean: 3.6 years; brain MR: 1.8 years) with respect to baseline variables (EDSS, annualized relapse rate, active T2 lesions, new T1 lesions and number of Gd-enhancing lesions) were analysed using parametric and non-parametric tests. One patient developed leukemia four months after the end of the treatment; no other serious adverse events occurred during treatment and the follow-up period. A clinically relevant reduction in the annualized relapse rate ( P < 0.0001 at end of treatment and P < 0.0001 at follow-up) and improvement in the EDSS ( P < 0.0001 at end of treatment and P = 0.0005 at follow-up) was found. At the end of treatment, 53% of patients experienced no increase in active T2 lesions, while 73% showed no increase in the number of new T1 lesions. At follow-up, 41 out of 45 (91%) patients showed a stable MRI pattern and were active-scan free. Despite potential serious adverse events, MITOX may be considered an option in selected patients with very active early MS. Multiple Sclerosis 2007; 13: 975—980. http://msj.sagepub.com

Long-term follow-up of patients (pts) with relapsed or refractory (r/r) follicular lymphoma (FL) treated with copanlisib.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 7553-7553
Author(s):  
Sirpa Leppä ◽  
Armando Santoro ◽  
Judit Demeter ◽  
George Follows ◽  
Georg Lenz ◽  
...  
Keyword(s):  
Adverse Events ◽  
Median Duration ◽  
Kinase Inhibitor ◽  
Late Onset ◽  
Progression Free Survival ◽  
Duration Of Treatment ◽  
Primary Analysis ◽  
Long Term Follow Up

7553 Background: The pan-class I phosphatidylinositol 3-kinase inhibitor copanlisib was approved by the FDA in September 2017 for treatment of relapsed FL based on results from the CHRONOS-1 study in pts with indolent non-Hodgkin lymphoma. We report efficacy and safety results of a 2-year (yr) follow-up of FL pts. Methods: Pts with indolent FL (grade [G] 1-3a) r/r to ≥2 prior lines of treatment received copanlisib (60 mg i.v. infusion) on days 1, 8, and 15 of a 28-day cycle. The primary endpoint was objective tumor response rate (ORR) per independent radiologic review (Cheson et al. 2007). Adverse events were reported using MedDRA (v20.1). Data cut-off: February 20, 2018. Results: 104 FL pts were enrolled. Median age was 62 yr (39% >65 yr), the median number of prior lines of anti-cancer therapy was 3 (range 2-8), and 27 pts (26%) were classified as having G3a disease. The ORR was 59%, with complete responses (CR) in 20% ( n=21); 14 pts had a CR at the primary analysis in June 2016. The median duration of response (mDoR) was 12.2 months (mo) (range 0.03-43 mo). Stable disease (SD) was observed in 33% of pts; median duration of SD was 7.8 mo (range 1.3-23 mo). Median progression-free survival (mPFS) was 11.2 mo (range 0.03-44 mo) with 33% alive and progression-free at 2 yrs. Median overall survival (mOS) was 3.2 yr (range 0.06-4.2 yr) with 67% alive at 2 yrs. Median duration of treatment was 26 weeks (wk) (range 1-192 wk); median duration of safety follow-up was 29 wk. In the G3a subset, the ORR was 67% (26% CR), mDoR was 10.9 mo, mPFS was 12.5 mo, and mOS was 2.5 yr. The most common treatment-emergent adverse events occurring in >25% of pts included (all grade/G3+): diarrhea (37%/9%), neutropenia (26%/23%), and pyrexia (28%/5%). Hyperglycemia (49%/40%) and hypertension (29%/23%) were transient. Incidences of pneumonitis (6.7%/1.9%) and colitis (1.0% G4) were low. Conclusions: Long-term follow-up of r/r FL pts treated with copanlisib revealed robust and durable responses with CRs exceeding 20%, including in pts with higher grade disease. The safety profile continues to be both manageable and favorable, with no evidence of late-onset severe toxicities. Clinical trial information: NCT01660451.

Managing problems with tracheoesophageal puncture for alaryngeal voice rehabilitation

2006 ◽  
Vol 120 (6) ◽  
pp. 470-477 ◽  
Author(s):  
O A Albirmawy ◽  
M N Elsheikh ◽  
M E Saafan ◽  
E Elsheikh
Keyword(s):  
Adverse Events ◽  
Success Rate ◽  
Medical Records ◽  
Multidisciplinary Approach ◽  
Clinical Analysis ◽  
Voice Rehabilitation ◽  
Voice Restoration ◽  
Early Results ◽  
Tracheoesophageal Puncture

Objectives: The tracheoesophageal puncture (TEP) technique and the insertion of its associated voice prostheses may give rise to adverse events. We present our experience with this technique, paying special attention to the incidence and management of these adverse events.Study design: A retrospective clinical analysis was undertaken.Methods: Seventy-five laryngectomized patients underwent TEP for voice restoration. They were divided into two groups: group one, 43 patients with secondary TEP; and group two, 32 patients with primary TEP. Patient medical records were reviewed for data on the incidence, management and outcome of adverse events encountered during patients' follow up.Results: Problems that arose in the patients were itemized as either early or late. The same patient could develop one or more problems in either group. The management of these problems, concerning the creation and maintenance of the TEP and associated prostheses, was noted. In group one, results were initially favourable in 91 per cent of patients and still positive in 81.4 per cent after three years. In group two, early results were favourable in all patients, and only two patients asked for late elective closure of the TEP (with a success rate of 93.7 per cent).Conclusions: Via an intensive and multidisciplinary approach to problems, most of the inevitable adverse events could be solved adequately, minimizing the discomfort of patients who had undergone laryngectomy and indwelling voice prosthesis insertion.

scholarly journals Randomized Clinical Trial: The Clinical Effects of Herb-Partitioned Moxibustion in Patients with Diarrhoea-Predominant Irritable Bowel Syndrome

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Yu-xia Ma ◽  
Xiao Liu ◽  
Cun-zhi Liu ◽  
Lin-peng Wang ◽  
Gang Guo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Adverse Events ◽  
Abdominal Distension ◽  
Clinical Effects ◽  
End Of Treatment ◽  
Significant Difference ◽  
Irritable Bowel

Objective. To explore the efficacy of Herb-partitioned moxibustion in treating IBS-D patients.Method. 210 IBS-D patients were randomly assigned on a3:3:2basis to group HM, group FM, or group PB for 4-week treatment. The change of GSRS total score at weeks 4 and 8, the changes of GSRS specific scores, and adverse events were evaluated.Results. Patients in group HM and group FM had lower GSRS total score at week 4 (1.98±0.303,2.93±0.302versus3.73±0.449) and at week 8 (2.75±0.306,3.56±0.329versus4.39±2.48) as compared with patients’ score in group PB. However, there was no significant difference of GSRS total score between group HM and group FM. The effect of HM was significantly greater than that of orally taking PB in ameliorating the symptoms of rugitus (0.38 versus 0.59,P<0.05), abdominal pain (0.28 versus 0.57,P<0.01), abdominal distension (0.4 versus 0.7,P<0.01), and increased passage of stools (0.06 versus 0.25,P<0.01) at the end of treatment period. In the follow-up period, patients’ therapeutic effect in group HM remained greater than that in group FM (in abdominal pain, abdominal distension, and increased passage of stools) and that in group PB (in loose stools).Conclusions. HM appears to be a promising, efficacious, and well-tolerated treatment for patients with IBS-D.

Nail–medullary canal ratio affects mechanical axis deviation during femoral lengthening with an intramedullary distractor

Injury ◽  
2015 ◽  
Vol 46 (11) ◽  
pp. 2258-2262 ◽  
Author(s):  
Nael Hawi ◽  
Mohamed Kenawey ◽  
Martin Panzica ◽  
Timo Stuebig ◽  
Mohamed Omar ◽  
...  
Keyword(s):  
Mechanical Axis ◽  
Medullary Canal ◽  
Axis Deviation ◽  
Mechanical Axis Deviation ◽  
Femoral Lengthening

scholarly journals Combination of Alarm-intervention and Reboxetine in Therapy- Resistant Enuresis

2018 ◽  
Vol 37 (3) ◽  
pp. 213-219
Author(s):  
Kirill Kosilov ◽  
Irina Kuzina ◽  
Yuliya Gainullina ◽  
Vladimir Kuznetsov ◽  
Liliya Kosilova ◽  
...  
Keyword(s):  
Combined Treatment ◽  
Intervention Group ◽  
Monotherapy Group ◽  
First Line ◽  
Duration Of Treatment ◽  
End Of Treatment ◽  
Before And After ◽  
Group A ◽  
Group B

Introduction: The first-line treatments of primary monosymptomatic night enuresis (PMNE) are alarm intervention and desmopressin. Some patients are resistant to these modes of treatment. Therefore Reboxetine has been used to treat PMNE in these scenarios in recent years and published in many studies. The aim of the study was to determine effectiveness and safety of combination of Alarm intervention and Reboxetine, to treat patients with therapyresistant enuresis.Material and Methods: Two hundred and nineteen children of both sexes were participated in the experiment (average age, 11.3 years). Participants were divided into three groups: Group A (71 patients, Alarm intervention), Group B (79 patients, Reboxetine as monotherapy), Group C (69 patients, Alarm intervention + Reboxetine). The duration of treatment was twelve weeks, followed by follow-up period of twelve weeks to see efficacy.Result: There was no significant change in number of enuresis episodes per week before and after treatment in a group B. The number of enuresis episodes per a week (weekly) in a group C reached: before treatment 5.3 (1.5), after treatment 1.0 (0.8), 3 three months after the end of treatment 0.7 (0.7). The percentage of patients with PMNE in a group C was significantly less immediately after the course of treatment (17.4%), and three months after treatment (24.6%).Conclusion: Combined treatment of therapy-resistant enuresis with use of Alarm Intervention and Reboxetine gives a high percentage of cured patients both immediately after therapy (82.6%) and three months after the end (75.4%).

Sign in / Sign up

Export Citation Format

Share Document