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Fractures, Bone clinical trials

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NCT ID: NCT01429012 Withdrawn - Nonunion Fracture Clinical Trials

Treatment of Atrophic Nonunion Fractures by Autologous Mesenchymal Stem Cell Percutaneous Grafting

Start date: November 2012
Phase: Phase 2
Study type: Interventional

Bone fractures heal most of the time particularly well and without complications. The solidification takes rarely more than two to three months. The wound healing depends greatly on a good blood supply and needs several steps. These processes culminate in a new mass of heterogeneous tissue which is known as the fracture callus. Unfortunately, 2%-5% bone fractures cannot achieve a proper solidification and between the ununited fragments a scar tissue appears. This incorrect healing induces pain and even infections. When this situation persists more than 6 months, it is referred to as nonunion fracture, which will require some form of intervention to stimulate the natural healing process of the body. First of all, good surgical techniques with stable immobilization should be applied and local infection should be excluded. Then stimulation of the callus is required. Cell therapy with bone marrow cells has emerged as a promising new approach for bone regeneration. Animal studies as well as preliminary human studies have shown that Mesenchymal Stem Cells, a particular kind of stem cells isolated from the bone marrow, could induce callus formation when injected in the nonunion site of a broken bone. In this study the investigators aim at determining whether Mesenchymal Stem Cells (MSC) isolated from the patient's bone marrow and injected in the nonunion site could be a safe and effective treatment for nonunion fractures. Patients will be randomized in two groups; one injected with Mesenchymal Stem Cell and the other injected with placebo. The investigators seek also to know how long it takes to develop the callus formation and whether there is a partial or a complete callus formation.

NCT ID: NCT01410929 Withdrawn - Multiple Myeloma Clinical Trials

Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multiple Myeloma

MM
Start date: May 2011
Phase: Phase 4
Study type: Interventional

The objective of this post market clinical study is to collect prospective clinical data to confirm the efficacy of RF Kyphoplasty for the treatment of pathological fractures of the spine caused by multiple myeloma.

NCT ID: NCT01410032 Completed - Clavicle Fracture Clinical Trials

Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures

Start date: July 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with plates or intramedullary flexible nails fixation.

NCT ID: NCT01408693 Completed - Clinical trials for Femoral Neck Fracture

Minimal Invasive Anterior Approach Versus Trans-gluteal Approach for Hemi-arthroplasty in Femoral Neck Fractures

MIS-CLAS
Start date: August 2011
Phase: Phase 4
Study type: Interventional

The aim of the study is to test the hypothesis that patients older than 60 years with a femoral neck fracture eligible for hemi-arthroplasty (HA) operated by an anterior minimal-invasive approach as compared to a standard lateral Hardinge approach show better functional recovery postoperatively as measured by the "Timed up and go"-test (TUG).

NCT ID: NCT01405703 Completed - Clavicle Fracture Clinical Trials

Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures

Start date: July 2011
Phase: N/A
Study type: Observational

This is a prospective, level II evidence comparison between two cohorts. This study is designed to compare the percutaneous versus open approach for plate fixation of diaphyseal clavicle fractures. This study includes questionnaires and measurements that will collect data on incision-related numbness, union rates, overall outcomes, complication rates of the two methods, infection rates, and overall satisfaction. The surgical procedure, all radiographs and follow-up visits to a minimum of one year are the principle investigators (PI's) standard of care for this injury. Measurements and questionnaires are related to the study.

NCT ID: NCT01404195 Completed - Sarcopenia Clinical Trials

Hyperprotein Nutritional Intervention in Elderly Patients With Hip Fracture and Sarcopenia

HIPERPROT
Start date: January 2012
Phase: N/A
Study type: Interventional

1. RATIONALE The unique characteristic of our study lies in the attempt to reverse the functional impairment experienced by sarcopenic patients with hip fracture using nutritional intervention. What makes this study different from prior studies is that it will be conducted in a hospital setting, unlike most prior studies, which were conducted in a community setting. The association between muscle mass and strength, inflammatory indices, and functional impairment versus dependence and fragility will also be measured. 2. HYPOTHESIS The hypothesis of our study is that nutritional intervention enriched in metabolites of essential amino acids (beta-hydroxy-beta-methylbutyrate) is effective for treating sarcopenia in elderly patients with hip fracture and improves functional level. 3. OBJECTIVES Primary objective is to assess functional improvement after nutritional intervention in sarcopenic patients with hip fracture, as measured using Barthel index. Secondary objectives will include: 1) to show the relationship between metabolic and inflammatory indices and sarcopenia; 2) to show how sarcopenia and its treatment influence the risk of fall; 3) to show muscle mass improvement; 4) to show increased strength; 5) to assess mortality and morbidity. 4. EXPECTED RESULTS The investigators expect to find that the supplemented group experiences throughout the study period a significant improvement in functional status (Barthel index), an increase in muscle mass, and a reduction in fat mass. An increased strength and a reduction in associated complications (falls) are also expected. The investigators hope to be able to show reductions in inflammatory indices and insulin resistance. To conclude, by improving muscle strength and mass the investigators expect to find a reduction in the disability and dependence of this population group.

NCT ID: NCT01402167 Withdrawn - Clinical trials for Vertebral Body Compression Fractures

Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

Start date: September 2014
Phase: N/A
Study type: Interventional

The primary objective of this study is to compare the volume of injected ciment (polymethyl methacrylate) between a group of patients treated with vertebroplasty and a group of patients treated via kyphoplasty. Secondary evaluation will compare the restoration of vertebral height, volume and cyphotic angle between the two techniques, as well as extravation of ciment and functional and quality of life aspects related to these techniques.

NCT ID: NCT01401712 Recruiting - Clinical trials for 3 or More Rib Fractures

Optimal Method of Pain Management in Patients With Multiple Rib Fractures

Start date: October 2012
Phase: N/A
Study type: Interventional

Rib fractures are a common injury of trauma patients and can cause significant pain which, if inadequately treated, can lead to impaired breathing, lung collapse, and respiratory failure. Hence, it is crucial to manage pain associated with rib fractures. Currently, epidurals are used to treat the pain, but placement can be risky as rib fractures are often associated with other injuries and complications. An alternative pain management option is the ON-Q® Pain Relief System. It is an FDA-approved device that automatically and continuously delivers medication to the region of the thoracic intercostal nerves. One study by Truitt et al (2010)demonstrated that the ON-Q® system effectively reduced pain and increased lung volumes after one hour, in patients with three or more rib fractures. However, that study sample was small and did not have a comparison group. In this study, we will compare two groups: 1) ON-Q system and 2) epidural analgesia. We hypothesize that trauma patients with three or more rib fractures, who receive pain management through the ON-Q® Pain Relief System achieve discharge criteria earlier and thus have a shorter hospital length of stay (LOS) when compared with epidural analgesia.

NCT ID: NCT01397643 Terminated - Clinical trials for Olecranon Fractures in the Elderly

A Trial of Non-operative Versus Operative Management of Olecranon Fractures in the Elderly

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

Proximal forearm fractures comprise approximately 5% of all fractures, with olecranon fractures accounting for almost 20% of thes fractures. There is limited conclusive evidence regarding the optimal treatment and outcome of these fractures within the elderly population with one case series in the literature describing 13 patients. Our trial includes all patients equal to or over the age of 75yrs presenting to the Edinburgh and Fife Orthopaedic Trauma Units with an isolated olecranon fracture. Patients who consent to enrol in the trial will be randomised to operative fixation using one of two treatment methods. Patients in the nonoperative group will be place in a sling for two weeks and then allowed to mobilise under supervised physiotherapy as per normal protocol. For those patients in the operative group, tension band wire of plate fixation will be employed depending on the choice of their supervising consultant. Patients will be evaluated over a one year period following their treatment.

NCT ID: NCT01394809 Completed - Clinical trials for Osteoporotic Distal Radius Fracture

Effects of Motor Cognitive Training on Functional Loss After Osteoporotic Wrist Fractures

PROFinD-TP4
Start date: August 2010
Phase: N/A
Study type: Interventional

The therapy results after distal radius fracture especially of elderly patients are often suboptimal. The central problem results from the inevitable, 3-6-weeks immobilization, which leads to reduction in ROM of the wrist, deterioration of muscle strength as well as malfunction of fine motor skills and coordination. Currently, there are no adequate proactive strategies to counteract these immobilisation problems. Hence the overall aim of our research project is to investigate the therapeutic potential of a motor-cognitive therapy on hand function after distal radius fracture. On the one hand the pilot study should provide information about the level of recruitment rate necessitated for an adequate sample size which allows reliable evidence for the therapy effects. On the other hand we want to evaluate the sensitivity and adequacy of the assessment instruments. The pilot is conceived as a controlled, randomised, longitudinal intervention study over 6 weeks with 3 groups. One experimental group imagine movements and actions without executing them. A second experimental group performs mirror training, in which visual feedback through a mirror activates additionally the contralateral hemisphere. The control group receives therapy as usual. There are three key domains to be analysed: function (PRWE), impairment (ROM, strength) and participation in social life/life quality (DASH, EQ5D).