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Necrosis clinical trials

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NCT ID: NCT04317872 Recruiting - Coxarthrosis Clinical Trials

Effect of Peri-operative Glucocorticoids on Short-term Functional Outcome After THA

DEXA
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

This randomized, single surgeon, placebo controlled, double blind study will be conducted in order to investigate whether or not peri-operative high doses of intravenous glucocorticoids improve short-term functional outcome after direct anterior total hip arthroplasty. So far, it has been proven that high dose glucocorticoids reduce immediate post-operative pain and nausea, but no data exists on functional outcome during the first 6 weeks. Our hypothesis is that patients in the intervention group will follow a so-called "get ahead, stay ahead" principle and that glucocorticoids can be considered an important tool (adjuvant treatment) in the enhanced recovery pathway after THA with significant socio-economic implications.

NCT ID: NCT04313010 Recruiting - Pulp Necrosis Clinical Trials

Effectiveness of Regenerative Endodontics Therapy for Single-rooted Mature Permanent Tooth With Pulp Necrosis

Start date: March 16, 2020
Phase: N/A
Study type: Interventional

This study is to evaluate the effectiveness of regenerative endodontics therapy in single-rooted permanent teeth with pulp necrosis,and compare the clinical efficacy of platelet rich fibrin (PRF) and blood clot (BC) as scaffolds.

NCT ID: NCT04301622 Active, not recruiting - Knee Osteoarthritis Clinical Trials

Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur

Start date: February 3, 2020
Phase:
Study type: Observational

MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION® CS tibial inserts. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.

NCT ID: NCT04275466 Recruiting - Clinical trials for Pancreatitis,Acute Necrotizing

Perform Necrotic Cavity Lavage or Not After Debridement of Infected Pancreatic Necrosis

NCLAD
Start date: June 12, 2020
Phase: N/A
Study type: Interventional

The infected pancreatic necrosis (IPN) should be treated by debridement and drainage. In recent years, the results of clinical research show that minimally invasive debridement such as video-assisted (laparoscope, nephroscope, endoscopy, etc.) and total laparoscopic debridement can significantly improve the prognosis of IPN patients. After a long period of clinical practice, laparoscope-assisted debridement was selected as the main surgical method in our center. In many large-scale clinical studies, patients after surgery underwent necrotic cavity lavage (such as small omental sac lavage, retroperitoneal space lavage, peripancreatic lavage, etc.), but its necessity and clinical significance were not clearly stated in the guidelines. At present, the clinical research mainly focuses on the improvement of minimally invasive debridement, and less on the necessity of lavage. In the past, necrotic cavity lavage was performed in IPN patients, but long-term clinical observation showed that lavage may lead to spread of infection and increase the incidence of lower extremity venous thrombosis which is not accorded with ERAS(Enhanced Recovery After Surgery). Therefore, since 2012, our center has stopped necrotic cavity lavage for IPN patients after debridement. We retrospectively analyzed the therapeutic effect from February 2014 to August 2017 and found that even without necrotic cavity lavage, better therapeutic effect could be achieved. Meanwhile it can simplify the operation process and avoid infection spread. This treatment method provides a new idea. However, it is a retrospective study not a randomized controlled trials(RCT) which is low effectiveness of proof. Therefore, we design this RCT to verify the necessity of necrotic cavity lavage after laparoscope-assisted debridement for patients with infected pancreatic necrosis.

NCT ID: NCT04255966 Active, not recruiting - Clinical trials for Arthroplasty Complications

Plasmafit® Revision Structan® Hip Endoprosthesis Cup

Start date: April 12, 2021
Phase:
Study type: Observational

The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.

NCT ID: NCT04210440 Completed - Hip Injuries Clinical Trials

The Treatment of Initial Stage of Hip Osteonecrosis: the Core Decompression

NEC15
Start date: March 1, 2003
Phase: N/A
Study type: Interventional

This retrospective study evaluates 52 cases of avascular necrosis of femoral head (AVN) treated by core decompression, bone chips allograft, fibrin platelet rich-plasma (PRF) and concentrated autologous mesenchymal stromal cells (MSCs).

NCT ID: NCT04190914 Completed - Primary Teeth Clinical Trials

Different Treatment Modality in Necrotic Primary Molars

Start date: February 7, 2020
Phase: N/A
Study type: Interventional

Necrotic primary molars in preschool children will be treated with the regeneration concept to provide a healthy biological environment within the root canal system and regression in clinical signs and symptoms which are the primary outcomes of regeneration treatment.

NCT ID: NCT04172129 Completed - Clinical trials for Post-traumatic Necrosis of the Femoral Head

Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical Study

Start date: April 26, 2011
Phase:
Study type: Observational

The primary purpose of this study was to evaluate the implant fixation of the NANOS™ Neck Preserving Hip Stem (OHST Medizintechnik AG, distributed by Smith & Nephew GmbH, Marl, Germany) by measuring the migration of the implant using the model-based roentgen stereophotogrammetric analysis (MBRSA).

NCT ID: NCT04145323 Completed - Breast Cancer Clinical Trials

Novel Application of Indocyanine Green as a Biomarker to Identify Tissue Necrosis in Mastectomy Patients

Start date: September 25, 2019
Phase: Early Phase 1
Study type: Interventional

Breast reconstruction is a common procedure that can dramatically improve the quality of life and satisfaction for women who undergo mastectomy, with over 100,000 procedures performed in the U.S. in 2018. The success of this procedure, however, is limited by its complications, including mastectomy skin flap necrosis, which occurs at a rate a 10-15%. Mastectomy skin flap necrosis causes significant morbidity in patients undergoing breast reconstruction, potentially compromising results and delaying oncologic management. In addition, necrosis can lead to infection, implant loss, and need for reoperation. Current approaches to identify mastectomy skin flap necrosis rely largely on the surgeon's assessment of skin flap color, capillary refill, temperature turgor and dermal bleeding. However, clinical assessment of necrosis is subjective and is not a reliable predictor of postoperative complications. ICG microangiography is an accepted adjunct method to aid in clinical judgment by identifying poor perfusion as a surrogate marker for tissue at risk for necrosis during reconstructive surgical procedures. However, transient alterations in blood flow seen by this method may not represent actual necrosis. Furthermore, the common practice of using vasoconstriction methods to prevent massive blood loss in plastic surgery also alters microperfusion and renders the microangiography inaccurate. There is an unmet need for reliable methods to identify mastectomy skin flap necrosis during or post breast reconstruction procedure in order to improve patient outcomes. Recently in animal models of burn or ischemic injuries, ICG dye was shown to preferentially bind to exposed phospholipids in the membranes of necrotic cells, thus acting as a biomarker for necrotic tissue, when imaged a day after injection rather than minutes after injection, as is standard for microangiographic use of ICG. This necrosis-avid property of ICG has broad translational potential for clinical use in a variety of disease processes that result in necrosis. However, no clinical application of the necrosis-avid property of ICG has been reported yet. In this study, the investigator will test the feasibility of combining the necrosis-avid property of ICG and the SPY imaging system at University of Wisconsin hospital to obtain delayed imaging of ICG fluorescence for direct necrosis detection in breast reconstruction in mastectomy patients. This project is an early feasibility study to establish whether ICG imaging, in a delayed fashion, can be used in mastectomy patients to aid in the detection of necrotic tissue in breast reconstruction wounds. Investigators will use the preliminary data generated from this pilot study to generate hypotheses and to power future studies.

NCT ID: NCT04142931 Recruiting - Clinical trials for Triple Negative Breast Cancer

Sequentional Immuno Apheresis Plasma Volume Escalation Cohort Study of Reduction of Soluble Tumor Necrosis Factor Receptors 1 and 2 (sTNFR1/2) With or Without Nivolumab in Patients With Inoperable or Metastatic Solid Tumors

Start date: February 24, 2020
Phase: Phase 1
Study type: Interventional

Sequential immune apheresis plasma volume escalation cohort study of reduction of soluble Tumor Necrosis Factors Receptors 1/2 (sTNFR1/2), with or without Nivolumab, in patients with inoperable or metastatic solid Tumors. This study evaluates Immunicom fs LW-02 device used with Spectra Optia apheresis system, aiming to answer two different study questions: - Safety, tolerability and effectiveness of the device. - Safety, tolerability and effectiveness of the device, employed as monotherapy, or combined with Nivolumab.