Safety and efficacy of matrix-associated autologous chondrocyte implantation with spheroid technology is independent of spheroid dose after 4 years.

Purpose: The aim of this study was to investigate the effect of product dose in autologous chondrocyte implantation (ACI) for the treatment of full-thickness cartilage defects of the knee and to assess its influence on clinical and morphological mid-term outcome.

Methods: Seventy-five patients were included in this single-blind, randomised, prospective, controlled clinical trial. Patients were assigned randomly to three different dose groups [low (3-7 spheroids/cm), medium (10-30 spheroids/cm), or high (40-70 spheroids/cm)] and assessed using standardised clinical and morphological scoring systems (KOOS, IKDC, MOCART) for 4 years following the intervention.

Matrix-Associated Autologous Chondrocyte Implantation with Spheroid Technology Is Superior to Arthroscopic Microfracture at 36 Months Regarding Activities of Daily Living and Sporting Activities after Treatment.

Objective: Matrix-associated autologous chondrocyte implantation (ACI) and microfracture (MF) are well-established treatments for cartilage defects of the knee. However, high-level evidence comparing microfracture and spheroid technology ACI is limited.

Design: Prospective, phase III clinical trial with patients randomized to ACI ( = 52) or MF ( = 50).

Development of Haemophilia Treatment in the Eastern Part of Germany over the Last Decade in the Kompetenznetz Hämorrhagische Diathese Ost (KHDO).

Introduction:  In 2005 the Kompetenznetz Hämorrhagische Diathese Ost published epidemiologic data about patients with haemophilia A (HA) and haemophilia B (HB) in the eastern part of Germany. This study provides data about the development of treatment in these patients over the past 10 years.

Methods:  Data from 12 haemophilia centres in eastern Germany were retrospectively collected for the year 2015 from patients' records.

Total Versus Near-total Thyroidectomy in Graves Disease: Results of the Randomized Controlled Multicenter TONIG-trial.

Background: Previous data suggest that the incidence of hypoparathyroidism after surgery for Graves disease (GD) is lower after subtotal thyroidectomy compared to total thyroidectomy (TT). The present study evaluated the incidence of postoperative hypoparathyroidism after near-total (NTT) versus TT in GD.

Methods/design: In a multicenter prospective randomized controlled clinical trial, patients with GD were randomized intraoperatively to NTT or TT.

Ventral rectopexy with biological mesh for recurrent disorders of the posterior pelvic organ compartment.

Purpose: Recurrent prolapse of the posterior pelvic organ compartment presents a management challenge, with the best surgical procedure remaining unclear. We present functional outcome and patient satisfaction after laparoscopic and robotic ventral mesh rectopexy (VMR) with biological mesh in patients with recurrence.

Methods: We analyzed data from 30 patients with recurrent posterior pelvic organ prolapse who underwent VMR with biological mesh from August 2012 to January 2018.

Clinical outcome and success rates of ACI for cartilage defects of the patella: a subgroup analysis from a controlled randomized clinical phase II trial (CODIS study).

Aim: Cartilage defects of the patella are considered as a problematic entity. Purpose of the present study was to evaluate the outcome of patients treated with autologous chondrocyte implantation (ACI) for cartilage defects of the patella in comparison to patient with defects of the femoral condyles.

Patients And Methods: 73 patients with a follow-up of 5 years have been included in this subgroup analysis of the randomized controlled clinical trial (RCT).

A Prospective, Randomized, Open-Label, Multicenter, Phase III Noninferiority Trial to Compare the Clinical Efficacy of Matrix-Associated Autologous Chondrocyte Implantation With Spheroid Technology Versus Arthroscopic Microfracture for Cartilage Defects of the Knee.

Background: Autologous chondrocyte implantation (ACI) and microfracture are established treatments for large, full-thickness cartilage defects, but there is still a need to expand the clinical and health economic knowledge of these procedures.

Purpose: To confirm the noninferiority of ACI compared with microfracture.

Study Design: Randomized controlled trial; Level of evidence, 2.

Nephrologists' perspectives on ambulatory care of patients with non-dialysis chronic kidney disease - A qualitative study.

Little is known on the perspectives of nephrologists on managing non-dialysis patients with chronic kidney disease (CKD). The purpose of this qualitative study was to explore the experiences and perspectives of nephrologists regarding the interface with general practitioners (GP) and GPs' management of patients with non-dialysis CKD, so that barriers to cooperation and need for improved management can be identified. Twenty semi-structured interviews were conducted for this qualitative study.

Radioablation by Image-Guided (HDR) Brachytherapy and Transarterial Chemoembolization in Hepatocellular Carcinoma: A Randomized Phase II Trial.

Background And Aims: The aim of this single-center, open-label phase II study was to assess the efficacy of image-guided high-dose-rate (HDR) brachytherapy (iBT) compared with conventional transarterial embolization (cTACE) in unresectable hepatocellular carcinoma.

Methods: Seventy-seven patients were treated after randomization to iBT or cTACE, as single or repeated interventions. Crossover was allowed if clinically indicated.

Systematic review and meta-analysis on non-opioid analgesics in palliative medicine.

Non-opioid analgesics are widely used for pain relief in palliative medicine. However, there is a lack of evidence-based recommendations addressing the efficacy, tolerability, and safety of non-opioids in this field. A comprehensive systematic review and meta-analysis on current evidence can provide a basis for sound recommendations in clinical practice.

Long-term radiation exposure in patients undergoing EVAR: Reflecting clinical day-to-day practice to assess realistic radiation burden.

Endovascular repair of aortic aneurysms (EVAR) has become an established treatment option currently applied in an increasing numbers of patients with aortic aneurysms. Advantages include reduced surgical trauma, procedural time, intensive care unit and hospital lengths of stay, blood loss as well as morbidity and mortality.The optimal imaging modalities in EVAR follow-up as well as the appropriate intervals between these follow-ups remain subject of controversial discussion.

Is stroke indeed a "Monday morning disease"?

Background And Purpose: The therapeutic time window of acute stroke is short. Decision on the use of intravenous thrombolysis is based on well-defined criteria. Any delay in the transport to a designated stroke centre decreases the odds of therapeutic success.

Assessment of the Efficiency of Stroke Awareness Campaigns in Hungary.

Background: The critical period of stroke management lies between the disease onset and the time of the emergency call, relying on stroke-related knowledge of the population. Public campaigns play a role in spreading relevant health information. Due to the substantial expenses of these campaigns, the assessment of their efficiency is reasonable.

Identification of Factors Influencing Cumulative Long-Term Radiation Exposure in Patients Undergoing EVAR.

Patients who undergo endovascular repair of aortic aneurysms (EVAR) require life-long surveillance because complications including, in particular, endoleaks, aneurysm rupture, and graft dislocation are diagnosed in a certain share of the patient population and may occur at any time after the original procedure. Radiation exposure in patients undergoing EVAR and post-EVAR surveillance has been investigated by previous authors. Arriving at realistic exposure data is essential because radiation doses resulting from CT were shown to be not irrelevant.

Safety of three different product doses in autologous chondrocyte implantation: results of a prospective, randomised, controlled trial.

Background: This study was conducted to assess the efficacy and safety of the three dose levels of the three-dimensional autologous chondrocyte implantation product chondrosphere® in the treatment of cartilage defects (4-10 cm) of knee joints. We hereby report the safety results for a 36-month post-treatment observation period.

Methods: This was a prospective phase II trial with a clinical intervention comprising biopsy for culturing spheroids and their subsequent administration (level of evidence: I).

Cementing a polyethylene cup into a well fixed acetabular metal-on-metal resurfacing component? An experimental investigation.

Introduction: Adverse reactions to metal debris often indicate revision surgery in metal-on-metal (MoM) hip arthroplasty and an exchange of the MoM bearing into either a metal on polyethylene or a ceramic-on-polyethylene articulation. At the moment the removal of the entire implant system is the most reasonable method. In order to avoid bone loss caused by the removal of a well-fixed acetabular component, the purpose of this study was to measure the stability of a cemented polyethylene (PE) cup in an acetabular hip resurfacing component and to examine if such a method could be suitable for clinical use.

The Effect of Cell Dose on the Early Magnetic Resonance Morphological Outcomes of Autologous Cell Implantation for Articular Cartilage Defects in the Knee: A Randomized Clinical Trial.

Background: Although autologous chondrocyte implantation (ACI) has been established as a standard treatment for large full-thickness cartilage defects, the effect of different doses of autologous chondrocyte products on structural outcomes has never been examined.

Hypothesis: In ACI, the dose level may have an influence on medium-term magnetic resonance morphological findings after treatment.

Study Design: Randomized controlled trial; Level of evidence, 1.

English language version of the S3-consensus guidelines on chronic pancreatitis: Definition, aetiology, diagnostic examinations, medical, endoscopic and surgical management of chronic pancreatitis.

Chronic pancreatitis is a disease of the pancreas in which recurrent inflammatory episodes result in replacement of pancreatic parenchyma by fibrous connective tissue. This fibrotic reorganization of the pancreas leads to a progressive exocrine and endocrine pancreatic insufficiency. In addition, characteristic complications arise, such as pseudocysts, pancreatic duct obstructions, duodenal obstruction, vascular complications, obstruction of the bile ducts, malnutrition and pain syndrome.

A follow-up on Acute Pain Services in Germany compared to international survey data.

Background: After the introduction of instruments for benchmarking, certification and a national guideline for acute pain management, the aim of this study was to describe the current structure, processes and quality of German acute pain services (APS).

Methods: All directors of German departments of anaesthesiology were invited to complete a postal questionnaire on structures und processes of acute pain management. The survey asked for staff, techniques and quality criteria, which enabled a comparison to previous data from 1999 and surveys from other countries.

The investigation and treatment of female pelvic floor dysfunction.

Background: 25% of all women report involuntary loss of urine, and 7% may require treatment.

Methods: This review is based on a selection of pertinent literature, including guidelines and Cochrane reviews.

Results: The assessment of pelvic floor dysfunction in women begins with a basic evaluation that is followed by special diagnostic tests if indicated.

Exercise training improves peak oxygen consumption and haemodynamics in patients with severe pulmonary arterial hypertension and inoperable chronic thrombo-embolic pulmonary hypertension: a prospective, randomized, controlled trial.

Aims: The impact of exercise training on the right heart and pulmonary circulation has not yet been invasively assessed in patients with pulmonary hypertension (PH) and right heart failure. This prospective randomized controlled study investigates the effects of exercise training on peak VO2/kg, haemodynamics, and further clinically relevant parameters in PH patients.

Methods And Results: Eighty-seven patients with pulmonary arterial hypertension and inoperable chronic thrombo-embolic PH (54% female, 56 ± 15 years, 84% World Health Organization functional class III/IV, 53% combination therapy) on stable disease-targeted medication were randomly assigned to a control and training group.

Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators: the NORDIC ICD randomized clinical trial.

Aims: This trial was designed to test the hypothesis that shock efficacy during follow-up is not impaired in patients implanted without defibrillation (DF) testing during first implantable cardioverter-defibrillator (ICD) implantation.

Methods And Results: Between February 2011 and July 2013, 1077 patients were randomly assigned (1 : 1) to first time ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres, and all ICD shocks were programmed to 40 J irrespective of DF test results.