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Fractures, Bone clinical trials

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NCT ID: NCT01637545 Terminated - Clinical trials for Facial Bones Fracture

Evaluation of Safety and Efficacy of Nasea(R)/Ramosetron Inj. in Patients Undergoing Facial Bone Fracture Operations

Start date: December 2011
Phase: Phase 4
Study type: Interventional

Postoperative nausea and vomiting (PONV) is one of the most common and distressing complications after anaesthesia and surgery, and may lead to serious postoperative complications This prospective, randomized study designed to evaluate the best injection time to get the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT(3) antagonist in patients undergoing facial bone surgery.

NCT ID: NCT01618539 Terminated - Long Bone Fracture Clinical Trials

Correlation of Bispectral Index Score and Total Intravenous Anesthesia (TIVA)

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

General Anesthesia is usually produced by an intravenous agent and then maintained with a breathing agent till the surgery is completed. However, there is a recent trend to produce and maintain general anesthesia solely with an intravenous agent, such as propofol, in view of its advantages. This delivery method is called Total Intravenous Anesthesia (TIVA). The depth of general anesthesia can be measured by an anesthetic depth monitoring device called Bispectral Index (BIS). The use of BIS to determine the depth of anesthesia has been well established whenever a breathing agent is used to maintain general anesthesia. However, the validity of using BIS with TIVA has not been adequately investigated. This study will compare the BIS values at different doses of TIVA in order to establish any correlation between the two. If such a correlation is established, BIS monitoring can safely be recommended to determine anesthetic depth under TIVA.

NCT ID: NCT01553630 Terminated - Tibial Fractures Clinical Trials

Reamed Locked Plating - Metaphyseal Fractures of the Distal Femur and Tibia

Start date: May 2010
Phase: N/A
Study type: Interventional

Comminuted metaphyseal fractures (OTA classification A2/3 and C2/3) of the distal femur and distal tibia are difficult to treat and typically have more complications than other metaphyseal fractures. Delayed union, nonunion and need for secondary bone graft procedures are frequent outcomes. These A2/3 and C2/3 fractures of the distal femur and distal tibia treated with locked plates often have a critical sized fracture gap (poorly organized cortical pieces many of which are stripped of soft tissue). Optimal management strategies that minimize both fracture healing time and complication rates remain controversial. Primary bone grafts or early secondary bone grafts have been recommended for these comminuted open fractures, but have not been studied as the primary end point in a randomized trial. There is a need to study primary bone grafting during open reduction and internal fixation (plating) of these difficult fractures, to determine if shorter healing time, and thus less need for reoperation, can be achieved. Hypothesis Acute autogenous bone grafting at the time of fixation will hasten clinical and radiographic union with a lower need for secondary procedures

NCT ID: NCT01535781 Terminated - Anemia Clinical Trials

Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?

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

The effect of Tranexamic acid on blood loss, hemoglobin and transfusions in patients with pertrochanteric hip fractures. Tranexamic acid is a well known drug used in many types of surgery. The investigators wish to investigate if the use of tranexamic acid can reduce the peri- and post-operative blood loss in patients who undergo surgery with a short intramedullary nail, for a pertrochanteric hip fracture. An interim analysis was planned when reaching 60 inclusions. The interim analysis was conducted only on the primary outcome (TBL). A difference in TBL of no less than 500 ml was considered a reason to halt the study. The 0.001 level was chosen as a simple approach to this interim analysis from the Haybittle-Peto boundary

NCT ID: NCT01532076 Terminated - Clinical trials for Osteoporotic Fractures

Effectiveness of Adipose Tissue Derived Mesenchymal Stem Cells as Osteogenic Component in Composite Grafts

ROBUST
Start date: June 2012
Phase: Phase 2
Study type: Interventional

Failure rates of up to 30% are reported after proximal humeral fractures despite angular-stable devices. This may devastate not only the functional outcome but also the independence of elderly patients. To increase bone mineral density and thereby holding-strength augmentation is an option. Autologous bone-graft, as current gold-standard, though is questionable in osteoporosis since osteoprogenitors are dysfunctional and the harvesting-morbidity considerable. Adipose tissue seems an alternative cell-source even in presence of osteoporosis. Stromal vascular fraction (SVF) cells isolated from lipoaspirates display osteogenic and vasculogenic potential and can be harvested in high numbers. Expansion associated with costly good-manufacturers-practice facilities is avoidable, so are repeated interventions. These cells have been successfully used to generate osteogenic composite grafts with intrinsic vascularity in preclinical models. For translation into clinical practice after a 20 patient external pilot a prospective randomized controlled trial with 270 patients is planned. For the trial lipoaspiration precedes open reduction and internal fixation in individuals over 60 years presenting with a proximal humeral fracture after low-energy trauma. Cells are isolated (Cellution®800/CRS) and wrapped around hydroxyapatite microgranules after embedding in a fibrin-gel for augmentation of the typical bone-void. Clinical/radiological follow-up is at 6 and 12 weeks for immediate complications and after 6, 9 and 12 months. Functional assessment is performed after 6 weeks, 6 and 12 months using the Quick-Dash- and Constant-Score. The primary outcome is a reduction in secondary dislocation by 50% during the first postoperative year. Secondary dislocation is diagnosed on plain radiographs by an independent board certified radiologist specialised in musculoskeletal imaging if one or more of the following criteria are met: - More than 20° varus collapse of the humeral head fragment in relation to the humeral shaft - Screw penetration through the humeral head

NCT ID: NCT01505985 Terminated - Hip Fracture Clinical Trials

Hip Fracture Surgery and Oral Nutritional Supplements

HIATUS
Start date: January 2012
Phase: Phase 3
Study type: Interventional

Senior hip fracture patients are the most vulnerable to malnutrition and protein deficiency. Low protein intake, like vitamin D deficiency, contribute to an increased risk for hip fracture. Notably, several clinical trials with protein supplementation in senior hip fracture patients resulted in fewer deaths, shorter hospital stay, and a higher likelihood of return to independent living. The proposal is to test the effect of an oral nutritional supplement (ONS) which has been designed to meet the specific nutrient needs of senior bone and muscle health. The hypothesis is that this ONS will improve functional recovery after hip fracture (as measured by Short Physical Performance Battery (SPPB)), improve quality of life, improve muscle mass, and- decrease falls and hospital re-admission after hip fracture.

NCT ID: NCT01494090 Terminated - Hip Fracture Clinical Trials

Statin in Hip Fracture

STAFF
Start date: August 2011
Phase: Phase 3
Study type: Interventional

Statins (or HMG-CoA reductase inhibitors) have largely proven their efficacy in the primary and secondary prevention of cardiovascular events. Many clinical and experimental studies support also a potential beneficial effect of statin therapy on venous thromboembolism (VTE). Patients with hip fracture are at high risk of VTE and cardiovascular events. The aim of this study is to evaluate the efficacy and the tolerance of a statin (rosuvastatin) in hip fracture surgery on the occurrence of venous and atherothrombotic events and the global mortality at six months. Subjects aged 60 years or over who are scheduled to undergo surgery for fracture of the upper portion of the femur (hip fracture) are eligible to participate to this multicentre, randomized, double-blind placebo controlled trial. They will receive either rosuvastatin (5 or 20 mg) or placebo for 6 months. The primary efficacy outcome is the incidence of an adjudicated composite of non fatal VTE, acute coronary syndrome, non fatal stroke, other acute ischemic arterial event, or all-cause death. Assuming a endpoint frequency of 20% in the control group, we calculated that 1200 patients will be required for the study to have 80% power to detect a 30% reduction in the relative risk with rosuvastatin (with a two-sided alpha level of 5%). The investigators assumed that rosuvastatin could have a positive benefit-risk ratio in patients undergoing orthopaedic surgery for hip fracture, by reducing vascular events and global mortality at six months.

NCT ID: NCT01484405 Terminated - Femur Fracture Clinical Trials

Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture

THA
Start date: June 2010
Phase: N/A
Study type: Interventional

There are two surgical approaches (incision types) used by surgeons who do total hip replacements. The purpose of this study is to determine which type of surgical approach (incision type) produces the best results for patients who have a total hip replacement. Null Hypothesis : There is no difference in complication rate, functional outcome, surgical time, or blood loss when comparing outcomes in patients receiving THA to hemiarthroplasty or ORIF for femoral neck fractures.

NCT ID: NCT01484366 Terminated - Clinical trials for Fractures of Radius and Ulna

Forearm Shaft Fractures: Plating of Radius and Ulna Versus Plating of Radius and Nailing of Ulna

Start date: September 2010
Phase: N/A
Study type: Interventional

The hypothesis is that intramedullary nailing of the ulna and plating of the radius will result in a superior outcome as evidenced by two primary end points: 1. a lower rate of implant pain 2. a lower re-operation rate to remove painful hardware.

NCT ID: NCT01480453 Terminated - Clinical trials for Rheumatoid Arthritis

Outcomes Study of the TM Humeral Stem Used in Primary, Total or Hemi Shoulder Arthroplasty

Start date: January 2, 2011
Phase:
Study type: Observational

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty.