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Fractures, Bone clinical trials

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NCT ID: NCT01081678 Completed - Fracture Healing Clinical Trials

Study To Assess FRacTure Healing With SclerosTin Antibody - Hip

STARTT-Hip
Start date: June 20, 2010
Phase: Phase 2
Study type: Interventional

This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.

NCT ID: NCT01077557 Completed - Fracture Clinical Trials

Fractures Stratified by HIV and Antiretroviral Therapy (ART) Status

Start date: November 2006
Phase: N/A
Study type: Observational

This US population-based study will explore the incidence of and risks for fracture among adults with and without human immunodeficiency virus (HIV) infection. The objectives are to determine the incidence of fracture among persons with and without HIV infection, compare risk factors for fracture among persons with and without HIV infection, and to examine the associations of antiretroviral (ARV) treatment exposure for incidence and risk of fracture among persons with HIV infection.

NCT ID: NCT01055223 Completed - Fractures, Bone Clinical Trials

Fracture Risk With Thiazolidinediones

Start date: May 2009
Phase: N/A
Study type: Observational

Treatment with thiazolidinediones (TZD) has recently been reported to possibly increase the risk of fractures in a randomized trial exploring the efficacy of rosiglitazone (RSG), metformin, or glyburide encompassing 4360 patients with type 2 diabetes. It is hypothesized that spironolactone, a diuretic that is broadly used for the treatment of fluid retention and edema associated with TZD, has a potential protective effect against bone fractures. However, to our knowledge, this has not been tested in diabetic patients treated with TZD. Amiloride is another diuretic that shares with spironolactone the anti mineralocorticoid ion gated channels activity and will be analysed in this study with regard to possible protective effect against bone fracture in combination with TZD. This study is a nested case-control study conducted among type 2 diabetes subjects exposed to TZD. The study aims to explore if the risk of fracture is reduced among type 2 diabetic subjects exposed to spironolactone and TZD. The study will compare the odds of any low impact fracture, and hand, foot, upper arm, wrist, and hip fracture incidence in subjects treated with TZD+spironolactone and TZD+amiloride compared to subjects treated with TZD only. The study population will consist of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one International Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months or at least 12 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO] or troglitazone) during their follow-up time available in the database.

NCT ID: NCT01052974 Completed - Clinical trials for Femoral Neck Fracture

Perioperative Analgesia by Femoral Perineural Catheter for Femoral Neck Fracture - Study KTcol

KTcol
Start date: March 26, 2009
Phase: Phase 4
Study type: Interventional

Therapeutic essay of phase IV, monocentric, prospective, randomized, in double-blind during 48 hours(then simple-blind),controlled by placebo. Abstract: The increasing incidence of the number of femoral neck fractures and the poor prognosis of this traumatological pathology involves an optimization of the diagnostic, therapeutic and analgesic care. A widespread collectively practice for the analgesia in prehospital or preoperative period is the single injection ("single shot") of local anesthetic with the technique of the femoral or iliofascial block. Nevertheless the single injection of a dose of local anesthetic associated or not with analgesic adjuvants, due to their pharmacological properties, can't prolong the efficiency of the loco-regional analgesia more than 12 hours. The aim of our study is to evaluate, in the patients admitted in emergencies for suspicion of femoral neck fractures, the perioperative efficiency of an analgesic treatment using a femoral perineural catheter (inserted from the hospital admission) with continuous infusion of ropivacaïne controlled by placebo (physiological serum).

NCT ID: NCT01052636 Completed - Hip Fracture Clinical Trials

Intervention Program for Elderly Patients With Hip Fracture

Start date: January 2001
Phase: N/A
Study type: Interventional

Specific Aims The long-term objective of this study is to examine the effectiveness of an intervention program for older patients with hip fracture. First, an intervention program for elderly patients with hip fracture will be developed and implemented, then, the effectiveness of the intervention program will be examined. The specific aims are as follows: 1. To develop a well conceived and feasible protocol of hospital discharge and sub-acute care that involves the coordinated work of health care professionals (physicians, surgeons, nurses, and physical therapists) and the informal caregivers. The feasibility of implementing such a protocol within the context of an intervention study subject to the constraints of the clinical setting (i.e., CGMH) will be evaluated in a pilot study. 2. To conduct a randomized clinical trial to evaluate the outcomes and costs associated with the proposed hospital discharge/sub-acute care protocol for elderly patients with hip fracture. Both experimental and case study methods will be used. Information on outcome indicators including clinical outcomes, quality of life, self-care ability, family caregiving outcomes, patient and caregiver satisfaction, and services utilization will be collected and compared between the control group and the experimental group. 3. To conduct a validation clinical trial to verify the results of the primary randomized clinical trial and increase the generalization of the study findings. 4. To estimate the cost of this care model and its variations for individual patients.

NCT ID: NCT01051869 Completed - Humeral Fractures Clinical Trials

Simple Decompression Versus Anterior Transposition of the Ulnar Nerve

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

Both simple decompression and anterior transposition of the elbow nerve (ulnar nerve) for acute displaced fractures of the elbow (distal humerus) treated with plate fixation are currently used by surgeons. We want to examine which treatment will overall give better results in regards to arm function and residual pain.

NCT ID: NCT01049191 Completed - Osteoporosis Clinical Trials

Bone Microarchitecture in Women With and Without Fracture

mMRI
Start date: October 2008
Phase: N/A
Study type: Observational

Osteoporosis is a common disorder of compromised bone strength causing 40-50% of women and ~25% of men to sustain fragility fractures during their lifetime. The reduction of bone strength in osteoporotic people results from loss of bone density and deterioration of bone quality. Bone quality is a complex amalgamation including macro- and micro-architecture, mineralization, turnover and damage accumulation. Currently, medications to reduce fracture risk are prescribed primarily on the basis of bone mineral density (BMD) measurement. Unfortunately, currently available BMD measurement technologies do not detect the aforementioned properties of bone quality; as such, less than half of individuals who sustain osteoporotic fractures are classified as "osteoporotic" by currently available diagnostic tools. Clearly, measures to enhance identification of those at high fracture risk are needed. High-resolution magnetic resonance imaging (HR-MRI) technology, such as that provided by MicroMRI, Inc., has outstanding potential to be such a tool. Therefore, our long-term goal is to evaluate and optimize the use of HR-MRI in fracture risk prediction; this pilot work is an essential step in attaining this goal. This research will investigate 72 postmenopausal women with normal or osteopenic BMD by dual-energy x-ray absorptiometry (DXA), 36 with prior low-trauma fractures will be compared with 36 age-, race- and BMD matched women without fracture. We hypothesize that 1.) Women with fractures will have evidence of microarchitectural deterioration on HR-MRI and 2.) Newly developed, more rapid MRI sequences designed at the UW will provide similar trabecular microstructure information more rapidly than the currently used, albeit investigational, technology produced by MicroMRI, Inc. Our specific aims are to a) Evaluate differences in MicroMRI parameters of trabecular microstructure (bone volume fraction, trabecular thickness, surface/curve ratio and erosion index) between age-, race- and BMD-matched postmenopausal women with and without fracture; b.) Correlate T2* relaxation time (a rapid indirect MRI measure of trabecular density and microstructure) with BMD measured by DXA, and microstructural parameters measured by MicroMRI. As an exploratory aim we will investigate HR-MRI parameters of trabecular microstructure obtained using a newly developed, rapid MRI sequence referred to as IDEAL-FSE with parameters obtained using the currently available MicroMRI, Inc. sequence.

NCT ID: NCT01035359 Completed - Clinical trials for Dorsally Displaced Intraarticular Distal Radius Fractures

Intraarticular Distal Radius Fractures, X-fix or Volar Fixation

Start date: August 2009
Phase: N/A
Study type: Interventional

Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate.

NCT ID: NCT01034943 Completed - Clinical trials for Dorsally Displaced Intraarticular Distal Radius Fractures

Extraarticular Distal Radius Fractures, X-fix or Volar Fixation

Start date: August 2009
Phase: N/A
Study type: Interventional

Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate.

NCT ID: NCT01017094 Completed - Tibial Fracture Clinical Trials

Pin Site Infection Prevention for Open Tibial Fracture

Start date: September 2007
Phase: Phase 3
Study type: Interventional

This study aimed to compare the efficacy of pin-tract infection prevention between silversulfadiazine and dry dressing. Methods: 30 patients with an open tibial fracture admitted to Songklanagarind hospital from September 2007 to June 2008 and treated by emergency debridement and external fixation were randomized into two groups, one treated with silversulfadiazine for infection prophylaxis (15) and a control group treated with dry dressing only (15). All patients were followed until the external fixator was removed. Pin-site infections were assessed and graded at each follow-up visit by an orthopaedist blinded to the mode of treatment. A culture from the pin site was done if an infection occurred.