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Fractures, Bone clinical trials

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NCT ID: NCT01810094 Completed - Lumbar Fracture Clinical Trials

Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures

FRIFIX
Start date: February 2013
Phase: N/A
Study type: Observational

Spinal injuries, such as vertebral fractures, often result in a significant instability of the spine and lead to acute or delayed neurological deficits. Depending on the type of injury there are various methods available to stabilize the spine. The proposed study should clarify whether the combined reduction and fixation with a minimally invasive approach can actually be done with the same precision as in a conventional approach. The primary endpoint of this investigation is the monosegmental anterior wedge angle (AWA), and its maintenance over the first 6 postoperative weeks. It is the aim of the study to gather key radiological, clinical and subjective patient outcome parameters for its patient population that will allow to compare the results to a historical group of patients. The study design is non-interventional, prospective, open,and multicentric.

NCT ID: NCT01808183 Completed - Clinical trials for Supracondylar Humerus Fracture

Pediatric Supracondylar Humerus Fracture NIRS Study

Start date: February 2012
Phase:
Study type: Observational

The purpose of this study is to use a device to compare the blood flow in the patient's injured arm to the patient's uninjured arm. This will help us determine 'normal' readings for this device for a child's forearm and may in the future help us detect children that have injured the blood vessels that go to the forearm when they have an elbow fracture. The patient will be one of approximately 100 people involved in this research project at Carolinas Medical Center, and the patient's participation will last until the patient is discharged from the hospital. It is hypothesized that if the blood vessel is uninjured, the readings on the NIRS device on the injured arm will be equal to the uninjured arm. It is also hypothesized that if the blood vessel of the injured arm is injured, the readings on the NIRS device will be different than on the uninjured arm.

NCT ID: NCT01807039 Completed - Clinical trials for Fracture of Neck of Femur (Hip)

Mortality Following Surgery for Proximal Femoral Fractures

HipMo
Start date: December 2012
Phase: N/A
Study type: Observational

Proximal femoral fractures are most frequent traumatologic and orthopedic diagnoses undergoing surgery. It affect most seniors and accompanied by a series of complications. The aim of our retrospective clinical trial is to establish a thirty-day mortality rate after surgical solutions, mortality during hospitalization and compare the types of anesthesia chosen during the performance (general vs. subarachnoid anesthesia).

NCT ID: NCT01803789 Completed - Clinical trials for Fracture of Metacarpal Bone

Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures

1-2-KiWI
Start date: May 2013
Phase: N/A
Study type: Interventional

Metacarpal V fractures are injuries of the upper extremities. They occur frequently, primarily in young adults.These fractures are caused by falling on the fist, sports accidents and direct or indirect forces. Surgical intervention is necessary for fractures with a strong palmar angulation of the metacarpal bone or rotational deformity of the small finger. Due to the absence of guideline recommendations decisions about therapy are made taking into account logistical aspects, available hardware, individual expertise and preferences. The objective of the study is to compare the advantages and disadvantages of single versus double Kirschner wires for intramedullary fixation of metacarpal V fractures in order to standardize national therapy procedures. Primary hypothesis: In the surgical therapy of the dislocated and/or rotational deformed metacarpal V neck fracture, osteosynthesis with a single Kirschner wire is not inferior to osteosynthesis with a double Kirschner wire with regard to the functional outcome after 6 month, as measured with the Disabilities of the Arm, Shoulder and Hands Score (DASH).

NCT ID: NCT01798472 Recruiting - Clinical trials for Femoral Neck Fractures

Hip Fractures Treated With Uncemented Arthroplasties

HUA
Start date: November 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to compare the functional and radiological outcome after displaced, femoral neck fractures treated with either cemented or uncemented arthroplasties. The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome at 12 month as the cemented arthroplasty.

NCT ID: NCT01797640 Completed - Tibial Fractures Clinical Trials

Intramedullary Nailing of Tibia Fractures

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

Currently, the treatment of choice for tibial fracture is intramedullary nailing. This procedure has been shown to have low rates of infection, high rates of bone healing, and a faster return to weight bearing and activity in comparison to conservative treatment. In concurrent fractures of the posterior or medial malleolus and the tibia, it is now common to identify, reduce, and fix the malleolar fracture prior to intramedullary nailing of the tibia. In this retrospective study, our aim is to establish that reducing malleolar fractures prior to tibial nailing is a safe treatment in which the reduction of the malleolus is maintained intraoperatively, postoperatively, and remains reduced until the fracture has healed.

NCT ID: NCT01796600 Completed - Clinical trials for Distal Limbs Bones Fractures

Assessment of Distal Limbs Fractures With Cone-Beam CT Newtom 5G

FRADICOBE
Start date: July 2012
Phase: N/A
Study type: Interventional

ConeBeam scanner (CBCT) is a widely technique used for dental and maxillofacial imaging. Patients can be set up in a sitting or a laying position in the, Newtom 5G CBCT allowing for an analysis of the distal appendicular skeleton. The investigators' hypothesis is that the cone-beam scanner could detect and characterize fractures of the extremities similarly to a multidetector CT (MDCT). 150 patients over 18 years requiring a CT scan for a suspected distal limb fracture or a preoperative assessment will be enrolled. The primary endpointis based on the ability of cone-beam scanner to properly characterize the type of fracture using a classification derived from Maurice E. Müller (AO) classification. Secondary endpoints will concern the depiction of the fracture, the assessment of the soft tissues near the fracture, quality of images, inter and intra-operator reproducibility and tolerance of the patient for the examination. Patients will have a MDCT considered as the reference exam, then a CBCT. Exams will be anonymized and read twice by two trained radiologists with 3-6 week intervals. The inter-observer agreement for the diagnosis of fracture type between the two techniques will be evaluated by a kappa coefficient. The evaluation of diagnostic performance will be achieved by studying the sensitivity, specificity, negative predictive value and positive predictive value, and its likelihood ratio. Kappa test will be performed to evaluate the consistency of the characterization of the fracture and the evaluation of soft tissue near the fracture. A Student t test will be performed for paired data if distributions are normal, a Wilcoxon test if not. To assess patient's tolerance, the percentages of (painful, not painful) will be calculated for each technique and will be compared using the Chi2 test (or Fisher's exact test if the chi can not apply).

NCT ID: NCT01795287 Recruiting - Tibial Fracture Clinical Trials

Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture

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

There is a elevated risk of acute compartment syndrome (ACS) related to tibial shaft fractures due to oedema and reduced blood flow in traumatised tissues. This may lead to lack of oxygen and even necrosis. Symptoms of ACS are severe pain, hypoaesthesia, pain during flexion of the ankle and swollen leg in clinical examination. Paralysis and lack of distal pulses are late symptoms of ACS. Many experts think that effective relief of pain caused by regional anaesthesia (RA) may hide the symptoms of the ACS. This may be incorrect. The evidence of dangers related to RA is based on old patient-series and single case-reports. Some of these studies report the symptoms of ACS (hypaesthesia and even pain) being caused by RA. Majority of the conclusions in these studies cannot be confirmed by an expert of RA. It is also possible that there are more hemodynamic changes related to general anaesthesia (GA) which may predispose to ACS. There are no modern, randomized and controlled studies of the safety of RA in patients with tibial shaft fracture.

NCT ID: NCT01789216 Completed - Clinical trials for Orthopaedic Fractures

Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain Study)

PAIN
Start date: July 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to definitively resolve questions regarding the use of multimodal pharmacologic pain management for orthopedic trauma patients in the context of a multicenter, randomized clinical trial. Also, as a significant proportion of this population develops chronic post traumatic osteoarthritis (PTOA), a sub-objective of this study is to examine the etiology and incidence of chronic pain and PTOA in this population.

NCT ID: NCT01788059 Completed - Nonunion Fracture Clinical Trials

The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital

Start date: January 2013
Phase: Phase 2
Study type: Interventional

Because the rate of non union of long bone in lower extremities specially in tibia in this two last decade due to malnutrition and smoking and other risk factors was increased, so many patient in our country suffer from non union on the other hand it seems that the use of the mesenchymal stem cells can irritate the union rate. Therefore the investigators decide to inject the mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure to non union site in patient that are resistant to other treatment. Then the investigators will follow the patient with monthly radiography and evaluate the callus volume and clinical union and any side effect of this treatment.clinical union consider to relief pain in non union site and be stable in examination.