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Acetabulum clinical trials

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NCT ID: NCT02848924 Completed - Fractures Clinical Trials

Current Incidence and Treatments Performed of Fractures of the Acetabulum and Pelvis in France in 2013

Start date: January 2015
Phase: N/A
Study type: Observational

Fractures of the acetabulum and pelvis are serious injuries to vital prognostic can play in cases of severe bleeding. In all cases the functional is a major issue with a potential reach of walking ability and maintaining the seated and standing positions. The treatment of such lesions requires management to a specialist, or the ability to use such centers for advice or transferring patients. This organization was recommended after the symposium of the French Society of Orthopedic Surgery (SOFCOT) in 2009. With the aging population, the incidence and clinical features of these fractures have evolved to worsening the functional prognosis. Club Basin acetabulum, body SOFCOT, wants to achieve an observational study assessing needs and practices at national and regional level. The long-term objective is to propose a regional organization of care of these patients in order to reduce morbidity and mortality associated.

NCT ID: NCT01230931 Recruiting - Clinical trials for Intra-Articular Fractures

Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)

Start date: October 2010
Phase: Phase 4
Study type: Interventional

Fractures of the acetabulum are considered rare in the general community, but are quite common in major metropolitan areas and tertiary care centers. These fractures are some of the most complex and challenging injuries to successfully treat in the orthopaedic field. Extensile surgical exposures are required to access this unique structure that comprises the cup of the hip joint. Large skin incisions, significant soft tissue dissection, and elevation of periosteum and muscle from the intact and fractured fragments are often required for anatomic reductions of the acetabulum and good outcomes. Thus, there are many sources of intra-operative bleeding that can sum up to require strategies aimed at preventing bleeding or replacing blood loss. Cell-saver and transfusion of allogeneic blood products can replenish blood loss. The use of cell-saver is a good solution, but it is quite expensive. Trained perfusionists are required and cost over $400 per hour. Disposable products are also required for each patient. While blood loss can be great, often not enough blood is captured, processed, and available for return transfusion. Allogeneic blood transfusion is often routine. Appropriate blood is often on short supply. The cost of processing, testing, and transfusion is also high: minimum of $260 per standard unit of packed red blood cells. While risks of disease transmission are rare, they exist and can have serious consequences to patients. Transmission can include CMV (common), Hepatitis C (1:1,600,000), HIV (1:1,800,000), and bacteria (1:500,000). Transfusion reactions are more common and include febrile reactions (1:100), allergic reactions (1:100), hemolytic reactions (less common), and transfusion-related acute lung injury (1:5000). Decreased operative times, aggressive electrocautery, ligation of identifiable vessels, minimal soft tissue dissection or stripping, topical agents such as gel foams, and thrombins are possible and available. But still, significant blood losses persist. Over the past decade, platelet gel products and fibrin sealants have been developed and provide another possible solution. There are some retrospective studies in the arthroplasty literature indicating these are good hemostatic agents. There is also some literature from the general, oral and maxillofacial, and spine surgical fields indicated these topical agents decrease intra-operative blood loss. But there are no large prospective, randomized studies in orthopedics, particularly traumatology, supporting the use of surgical hemostats. This study protocol will use one surgical hemostat (Vitagel, Stryker). The study is a prospective, randomized controlled trial to evaluate this type of topical agent's role as a hemostatic agent in certain acetabular fracture types that require a non-extensile, posterior approach. Three fellowship-trained traumatologists will be involved: Drs. Milan Sen, Tim Achor, Josh Gary, Mark Prasarn, John Munz, and Andrew Burgess. Dr. Ambrose will assist in analyzing the data and statistical outcomes. Purpose of Project. The purpose of our study is to determine whether surgical hemostats can minimize blood loss, need for allogeneic blood transfusions and their associated risks, and costs in patients with certain acetabular fractures requiring operative fixation via a non-extensile Kocher-Langenbeck surgical approach. Since surgical hemostats and other topical agents like platelet gel products have also been linked with improved wound healing, a secondary endpoint will be incidence of wound dehiscence and/or infections. The investigators primary hypothesis is the topical hemostat will result in lower blood losses intraoperatively and fewer units of perioperative blood product transfused.