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Complications; Arthroplasty clinical trials

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NCT ID: NCT02774174 Completed - Clinical trials for Complications; Arthroplasty

The Evaluation of the METS™ Proximal Humeral System

Start date: May 2016
Phase:
Study type: Observational

This study is a single centre, non-randomised, post market clinical follow up examining retrospective patient data from a series of surgical cases; which involved the endoprosthetic replacement of the proximal humerus using the Stanmore Implant Worldwide METS (Modular Endoprosthetic Tumour System) Proximal Humeral system. The objective of this study is to evaluate the retrospective patient data where patients have been followed up for at least 12 months post operation; to demonstrate the safety of the METS Proximal Humeral replacement system.

NCT ID: NCT02598700 Completed - Hip Osteoarthritis Clinical Trials

Correlation of Spinopelvic Parameters and Acetabular Cup Orientation

Start date: February 2016
Phase:
Study type: Observational

In total hip arthroplasty, cup anteversion is an important factor in stability. Lewinnek's safe zone and functional anteversion are often used to assess appropriate orientation. However, these approaches do not consider the effect of the spinopelvic chain and lumbar mobility when in the seated position. This study will measure functional anteversion when standing and sitting with patient-specific computer models and define a quantitative relationship between the change in functional anteversion and spinopelvic parameters. This will challenge the historical paradigm of the safe zone and provide a tool to define anteversion based on a patient's mechanics and reduce risk of dislocation.

NCT ID: NCT02124031 Completed - Physical Disability Clinical Trials

Mexican Initiative of Patients With Osteoarthritis and Rheumatoid Arthritis (IMPACTAR)

IMPACTAR
Start date: December 2013
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate quality of life, degree of disability, treatment patterns and economic impact of hand and knee Osteoarthritis and Rheumatoid Arthritis in Mexico.

NCT ID: NCT02043132 Completed - Clinical trials for Blood Loss, Surgical

Tranexamic Acid in Reverse Total Shoulder Arthroplasty

TXA
Start date: September 2013
Phase: Phase 2/Phase 3
Study type: Interventional

To the Investigators' knowledge, TXA has not been studied in the setting of reverse total shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing perioperative administration of TXA to placebo in the setting of RTSA. The purpose of this study is to examine the efficacy of TXA in reducing overall blood loss and transfusion rates in patients undergoing reverse total shoulder arthroplasty.

NCT ID: NCT01882751 Completed - Clinical trials for Complications; Arthroplasty

In Vivo Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant

Start date: June 2013
Phase:
Study type: Observational

A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Previously, most experimental studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that permit error due to undesired motions between markers and the underlying bone. More recently, fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA. ConforMIS has attempted to follow a clearly different path than the major orthopaedic companies. They have chosen to offer patients a personalized knee implant based off of each patient's femoral and tibial bone geometry. The hypothesis is that these subjects will experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25 patients implanted with a traditional TKA design to determine if there are any kinematic differences between these TKA designs.

NCT ID: NCT01820611 Completed - Clinical trials for Rheumatoid Arthritis

Arcos Revision Stem: Evaluation of Clinical Performance

Start date: February 2013
Phase:
Study type: Observational

The primary purpose of this study is to evaluate the clinical performance of the Arcos Revision Stem system, determine the stability of the implants, and evaluate any relationship between Paprosky bone defect level and the success of the Arcos Stem.

NCT ID: NCT01514318 Completed - Osteoarthritis, Hip Clinical Trials

Encore Revelation Hip Stem

Start date: February 2012
Phase: N/A
Study type: Observational

The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the Revelation Hip Stem prior to 2002.

NCT ID: NCT01442298 Completed - Clinical trials for Complications; Arthroplasty

A Comparison Between an Individual Low Tourniquet Pressure Versus a Standard Pressure During Total Knee Arthroplasty

Start date: October 2008
Phase: N/A
Study type: Interventional

The use of bloodless field is a helpful and important method in orthopedic surgery. The surgery can be done without interrupting bleedings, while keeping an exact overlook of the anatomy. However the method is not without risks, and complications of various kind may occur. One of the most important factors to minimise the risk of complications, is to keep the lowest possible cuff pressure. Previous electromyography (EMG) studies have indicated neuromuscular abnormalities after bloodless field among many patients which may lead to a prolonged rehabilitation period since they cause a postoperative weakness in the muscles. Although in these studies an unnecessary high tourniquet pressures were used and the EMG tests were made 6 weeks and 6 months after the surgery. With today's demand for fast rehabilitation, there is a need for better knowledge if lower tourniquet pressure in bloodless field surgery may lead to less neuromuscular abnormalities. Limb Occlusion Pressure (LOP) is the tourniquet cuff pressure required to occlude the blood flow. It accounts for a patients limb and vessel characteristics and the type and fit of the tourniquet cuff. The method has developed and is now simplified, by using an automatic (plethysmographic) sensor placed on the second toe on the involved limb, and after administration of anaesthesia, and immediately before limb preparation and draping it measures the limb occlusion pressure. When surgery starts, the cuff is inflated again; plus a safety margin based on the LOP pressure measured. The LOP method is still rarely used it has been seen as difficult and time consuming. The primary aim of this study is to investigate whether you can reduce the used tourniquet pressure with the new LOP measurement technique and still have a adequate bloodless field; and if this will lead to any clinical difference regarding postoperative pain. The secondary aim is to investigate the difference between the test groups concerning muscle function and wound healing and if these are remaining and of clinical importance. The third aim is to study how common neuromuscular abnormalities are after the use of bloodless field with lower cuff pressures and if there are any differences between the standard method and the LOP method.

NCT ID: NCT01373112 Completed - Osteoarthritis Clinical Trials

Articulating Versus Static Antibiotic Loaded Spacers for the Treatment of Prosthetic Knee Infection

Start date: December 2011
Phase: N/A
Study type: Interventional

Infection remains a difficult-to-treat complication of total knee arthroplasty. The gold standard treatment is two-stage removal of the prosthesis with later replacement of permanent implants. The first stage consists of removal of the infected arthroplasty components and the surrounding devitalized tissue, copious pulsed irrigation, and placement of a temporary antibiotic-impregnated cement spacer. This spacer typically is left in place six weeks, during which time the patient receives intravenous antibiotics. After the surgeon feels that the infection has been eradicated, or if the patient requires repeat debridement, a second operative procedure is performed. While the use of an antibiotic-loaded spacer is well accepted, whether the spacer should immobilize the knee (a so-called "static" spacer) or allow for range of motion (a so-called "articulating" spacer) is controversial. Proponents of articulating spacers argue that they prevent scarring of the musculature surrounding the knee resulting in easier reimplantation, improved long-term knee function, and improved range of motion. Proponents of static spacers argue that immobilization of the periarticular soft tissues aids in clearance of the infection and is simpler to fashion intraoperatively. While good results have been described with both methods, comparative trials have been conflicting as to whether spacer design alters knee function, operative time, and range of motion. Equipoise exists within the literature, and no randomized clinical trial has been conducted to evaluate this issue. The purpose of this study is to compare articulating and static antibiotic-impregnated spacers for the treatment of chronic periprosthetic infection complicating total knee arthroplasty through a prospective, randomized clinical trial. The goals of this trial are to determine the effect of spacer design upon eradication of infection, knee function, ease of reimplantation, and range of motion. The investigators hypothesize that articulating spacers will provide shorter operative times at reimplantation, while improving knee function and range of motion.

NCT ID: NCT01373099 Completed - Osteoarthritis Clinical Trials

Study of Antibiotic Spacer Design to Treat Infection After Hip Replacement

SPACERHIP
Start date: August 2011
Phase: N/A
Study type: Interventional

Infection remains one of the most difficult-to-treat complications of total hip arthroplasty. The gold standard treatment is two-stage removal of the prosthesis with later replacement of permanent implants.The first stage consists of removal of the infected arthroplasty components and the surrounding devitalized tissue, copious pulsed irrigation, and placement of a temporary antibiotic-impregnated cement spacer. This spacer is typically left in place six weeks, during which time the patient receives intravenous antibiotics. After the surgeon feels that the infection has been eradicated, or if a second debridement is required, a second operative procedure is performed. While the use of an antibiotic spacer is well accepted, whether the spacer should immobilize the hip (a so-called "static" spacer) or allow for range of motion (a so-called "articulating" spacer) is controversial. Proponents of static spacers argue that immobilization of the periarticular soft tissues aids in clearance of the infection and that these spacers are simpler to fashion intraoperatively. Proponents of articulating spacers argue that they improve hip function, prevent damage to the musculature surrounding the hip, allow easier reimplantation, improve hip function, and prevent dislocation following hip reimplantation. While good results have been described with both methods, comparative trials have been conflicting as to whether spacer design alters hip function, operative time, and dislocation rates. Equipoise exists within the literature, and no randomized clinical trial has been conducted to evaluate this issue. The purpose of this study is to compare articulating and static antibiotic-impregnated spacers for the treatment of chronic periprosthetic infection complicating total hip arthroplasty through a prospective, randomized clinical trial. The goals of this trial are to determine the effect of spacer design upon eradication of infection, hip function, ease of reimplantation, and dislocation rates. The investigators hypothesize that articulating spacers will provide shorter operative times at replantation while improving hip function and hip dislocation rates following hip reimplantation.