View clinical trials related to Necrosis.
Filter by:This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis
EUROSSTEM is intended for use in primary and revision total hip replacement surgery. Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. As part of post market vigilance, EUROS will collect data on EUROSTEM performances and safety
This Post Market Clinical Follow-Up (PMCF) study to evaluate the performance and safety of the cemented TrendHip® stem in a prospective follow-up study with patients who underwent a hip arthroplasty with the investigational product (representative of usual clinical practice), at two follow-up examinations
This randomized clinical trial intended to evaluate the efficacy of a technique of root canal treatment of deciduous molars with non-instrumentation of root canals and use of a paste containing antibiotics (chloramphenicol and tetracycline) and zinc oxide and eugenol (CTZ group). The hypothesis is that the efficacy of non-instrumentation treatment is non-inferior than the standard treatment involving manual instrumentation of root canals and filling with zinc oxide and eugenol paste (ZOE group) after 24 months of follow-up. Children will be randomly allocated to one of the two groups: CTZ group or ZOE group. In the CTZ group, after the location of root canals entrance, an initial irrigation will be conducted using 1% sodium hypochlorite. Then, CTZ paste will be placed in the pulp chamber floor, over the root canal entrances. The instrumentation of the root canals will not be performed for children allocated to this group. For the ZOE group, manual instrumentation with endodontic K files will be performed, aided by irrigation with 1% sodium hypochlorite. After the end of the instrumentation, root canals will be filled with ZOE paste. All teeth will be restored with bulk-fil resin composite. Children will be followed-up for 6, 12, 18 and 24 months after the treatment. The primary endpoint will be the success of endodontic treatment evaluated by clinical and radiographic methods after 24 months. Based on a non-inferiority limit of 15% in the success rate, it was estimated an anticipated sample size of 218 (109 per group), divided among the centers. Other secondary endpoints will be clinical time spent with the treatments, children's behavior during the treatment, discomfort immediately after the end of the treatment reported by the children, post-operative pain, improvement in the negative impact of Oral Health-Related Quality of Life, costs and cost-efficacy.
In this pilot study, we will test the hypothesis that a POPOP for currently ineligible UAMS orthopedic surgery patients wanting hip or knee replacement improves markers of preoperative health, ability to reach a BMI threshold <40 kg/m2 required for surgical eligibility, and postoperative outcomes versus SOC.
The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
The study design is a randomized controlled trial and up to 120 teeth, 50 in each of the 2 groups, will be enrolled from the patients at the National University Centre for Oral Health Singapore (NUCOHS) Endodontic unit. The primary aim of this study is to compare the efficacy of selective caries removal (SCR) and pulpotomy in preventing pulp necrosis and apical periodontitis in teeth with deep dental caries radiographically extending at least 2/3 into the width of dentine, over a review period of 6 months, 1, 3, and 5 years. The secondary aim of this study is to compare the costs (tangible i.e. restorative treatment costs, and intangible i.e. number of treatment visits and time spent at clinic to complete treatment) and tooth survival in the oral cavity, between teeth treated with SCR and pulpotomy.
This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study. The objectives of this study are to confirm the long-term safety, performance and clinical benefits the Exception Cementless femoral stem (standard and varized) when used in primary total hip arthroplasty.
This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of surgical workflow efficiency, patient pain and function outcome and adverse events data. This study might include Persona, Nexgen and Vanguard product families using the ROSA Total Knee Robotic system or conventional instrumentation. The primary objective is to evaluate the accuracy of implant alignment for ROSA Total Knee robotic instrumentation compared to conventional instrumentation.
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.