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Fractures, Bone clinical trials

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NCT ID: NCT02272972 Completed - Hip Fractures Clinical Trials

Performance Improvement Program on Imaging II

Start date: October 2014
Phase:
Study type: Observational

This study consists of a retrospective and a prospective part. For each part and in each of 5 clinics, one intraoperative postimplant image (lateral view) of 25 patients with pertrochanteric fractures will be assessed by 5 surgeons per clinic. There are two assessments in the retrospective part. a) before an educational intervention, b) after the educational intervention. The evaluated images at these two timepoints are identical. In the prospective part, the surgeons apply their new knowledge from the educational intervention. They perform the positioning of the patient during the intraoperative fluoroscopy and record the image according to the teaching material. One postimplant image of each patient will be used for the evaluation. At all three timepoints of image assessment, a questionnaire with the same set of 7 criteria (Q1-Q7) for assessing the radiographs is used. The criteria refer to the content of the educational material.

NCT ID: NCT02267330 Completed - Hip Fractures Clinical Trials

Gonadal Radiation Exposure and Risk Secondary to Fluoroscopic Imaging During Trauma Surgery

Start date: February 2012
Phase:
Study type: Observational

The aim of this cohort study is to precisely measure patients' exposure to gonadal radiation during orthopaedic trauma surgery involving the acetabulum, pelvis, hip, and femur, and to apply these findings to a previously described and validated formula to determine the increased risk of future adverse health effects to the reproductive organs. The investigators null hypothesis is standard of care use of x-ray fluoroscopy during treatment of pelvis, hip, and femur fractures will not expose patients to a significant gonadal radiation load. Analysis of patients' intraoperative radiation doses by means of a previously validated formula will not display a significantly increased risk of adverse health events in the reproductive organs.

NCT ID: NCT02256059 Completed - Clinical trials for Fracture, Closed, Comminuted, Healing

Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension

LatClav
Start date: June 2011
Phase: N/A
Study type: Observational

Treatment of lateral fractures of the clavicle is challenging and has been controversially discussed for a long time due to high non-union rates in non-operative treatment and high complication rates in surgical treatment. A recently developed implant was proven to ensure a biomechanically sufficient fixation of fractures leading to bony union and promising functional outcome in a small collective of patients.

NCT ID: NCT02247661 Completed - Clinical trials for Femoral Neck Fracture

Hip Abductor Strengths, Limping and Trochanteric Tenderness After Hip Arthroplasty Due to Femoral Neck Fracture

HASAP
Start date: February 2012
Phase: N/A
Study type: Observational

A prospective cohort study to compare the direct lateral and poster-lateral approach concerning abductor function. Patients admitted with a femoral neck fracture operated with a hemiarthroplasty through a direct lateral or a poster-lateral approach were screened for inclusion. Patients with altered mental status SPMSQ >7, pathological fractures, non-walkers were excluded. Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 1 year postoperatively by clinical examination. Sample size were estimated to 30 patient in each group. Primary outcome variables were trendelenburg test, abductor strength measured with dynamometry, trochanteric tenderness measured with algometry and palptation.

NCT ID: NCT02239523 Completed - Clinical trials for Osteoporotic Fracture

Effectiveness or Orthopedic Intervention in Osteoporosis Management After a Fracture of the Hip With Cost-Benefit Analysis

Start date: February 21, 2017
Phase: N/A
Study type: Interventional

Patients who present with fragility fractures are consistently under-evaluated and under-treated for underlying osteoporosis. This point of care represents a lost opportunity to prevent future fractures. The medical field treats the fracture as if the fall is the problem, but bone quality is the real problem. Studies have consistently shown that the recommendations of the International Osteoporosis Foundation and World Health Organization are not being followed. Orthopedics treats the patients for their fractures and primary care physicians focus on general health but no one is taking responsibility for bone health. Strategies to convince primary care to assume care have not succeeded. On the other hand, strategies where orthopedics takes some responsibility have shown success. This prospective 2-arm study will evaluate the success of effort by an academic orthopedic department in osteoporosis evaluation and treatment. We hypothesize that with greater effort by the orthopedic department, the better the adherence to standards of care. A cost benefit analysis will be made in parallel.

NCT ID: NCT02234414 Completed - Clinical trials for Postmenopausal Osteoporosis

Epidemiology, Identification Rate and Treatment Penetration of Osteoporotic Vertebral Fractures in Switzerland

SwOF
Start date: February 2009
Phase: N/A
Study type: Observational

In Switzerland, the prevalence of vertebral fractures in community- dwelling women is unknown and the published data from the Swiss hospitals statistics represent only the tip of the iceberg. In addition, the percentages of women correctly identified with vertebral fractures due to osteoporosis and the treatment rate of these women with a drug proven to reduce the risk of further fractures are unknown. Furthermore, it is not known whether the prevalence of vertebral fractures differs between urban and rural areas or between mountain areas and plain country, e.g. due to possible differences in sun exposure (vitamin D production) and/ or in physical activity and/ or dietary habits. Clinical signs and symptoms leading to the suspicion of vertebral fracture(s) lack either sensitivity (wall-occiput distance) or specificity (rib-pelvis distance). Whether a combination of both would improve sensitivity and specificity is unknown. The gold standard for the diagnosis of vertebral fracture relies on antero-posterior and lateral X-Rays of the thoracic and lumbar spine. Despite standardization of X-Ray readings, a retrospective study of hospitalized elderly patients has shown that as many as 50% of the radiographic reports failed to note the presence of moderate to severe vertebral fractures. In a primary care setting, fewer than 2% of the women received diagnoses of osteoporosis or vertebral fracture, although expected prevalence is 20% to 30% and appropriate drug treatment was offered to only 36% of the diagnosed patients. The recent availability of software for vertebral fracture assessment (VFA) coupled to DXA measurements allows for the detection of vertebral deformities, which is critical for management of osteoporosis, as the existence of such deformities substantially increases the risk of subsequent fracture. Recently published results show that VFA allows the diagnosis of a vertebral fracture. The sensitivity of VFA for detection of vertebral fractures compared to expert radiologist reading of X-ray is excellent for grade 2 and 3 fractures, ranging between 90-94%.

NCT ID: NCT02230514 Completed - Clinical trials for Atrophic Nonunion of Fracture

Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones

Start date: November 20, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac crest. XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and Tissue Bank of Catalonia). The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration up to consolidation of non-union fractures.

NCT ID: NCT02216812 Completed - Clinical trials for Distal Radius Fracture

Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?

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

The reported prevalence of disproportionate pain and disability among patients recovering from a fracture of the distal radius varies widely. Literature reports numbers between 1% and 37%, perhaps in part because it is poorly defined, known by so many different names, subjective, and unverifiable. The investigators are interested in the effect of vitamin C after distal radius fractures on objective measurement of finger motion, patient reported outcome measures, and pain intensity, instead of the previously used, subjective and imprecise criteria for complex regional pain syndrome. Patients presenting to the Hand and Orthopaedic Trauma Services of MGH with a distal radius fracture will be asked to participate in this clinical trial. Patient will be randomly assigned to take either placebo or vitamin C 500 mg until full finger motion is attained as regarded by the treating physician at follow-up or for 6 weeks. The investigators hypothesize no difference in finger stiffness at 6 weeks measured by distance to palmar crease of the index through little finger between patients taking vitamin C or placebo after a distal radius fracture. Additionally, the investigators assess finger stiffness by range of motion and stiffness of the thumb, and difference in PROMIS upper extremity function and pain score both measured at six months.

NCT ID: NCT02198768 Completed - Ankle Fractures Clinical Trials

Ankle Fracture vs Ankle Fracture-Dislocation

Start date: September 2012
Phase:
Study type: Observational

The purpose of this study is to compare outcomes of patients with an ankle fracture to those with ankle fracture-dislocations. We hypothesize that long-term clinical outcomes for patients sustaining ankle fracture dislocations are poorer than those without dislocation.

NCT ID: NCT02190903 Completed - Delirium Clinical Trials

A Trial To Assess Risk of Delirium in Older Adults Undergoing Hip Fracture Surgery With Spinal or General Anesthesia

Start date: October 2013
Phase: N/A
Study type: Interventional

This pilot project will address the gaps in knowledge regarding the effect of anesthetic technique on the risk of delirium through an adequately-powered trial employing standardized regimens for treatment and outcome assessment to test the hypothesis that use of spinal versus general anesthesia decreases the risk of delirium after hip fracture surgery.