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Fractures, Bone clinical trials

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NCT ID: NCT01896011 Completed - Clinical trials for Non Displaced Atypical Femoral Fractures

Effect of Teriparatide on Fracture Healing in Patients With Incomplete Atypical Femur Fractures

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

Atypical femur (thigh bone) fractures (AFFs) are uncommon low-trauma fractures which often occur without warning, are highly debilitating, and are slow to heal. As physicians learn more about them, AFFs are increasingly being identified prior to a total break. However, there's no evidence on the best way to treat these non-displaced AFFs. One option is teriparatide, an osteoporosis medication that can build new bone. Investigators will conduct a double blind randomized placebo controlled trial to examine whether teriparatide use in AFF patients with an incomplete break will help accelerate fracture healing and prevent surgical intervention. Co-primary outcomes include change in WOMAC scores from baseline to 12 months and number of participants requiring surgical intervention at 12 months. Investigators will recruit 60 women and men over the age of 30 who have experienced an incomplete AFF. Participants will be randomly assigned to either teriparatide (20 mcg/day) or placebo (using an identical injection pen) for up to 2 years. As AFFs are highly debilitating, a trial examining the use of Teriparatide in this population is urgently needed.

NCT ID: NCT01883063 Terminated - Clinical trials for Minimally Displaced Intra-articular Distal Radius Fracture

Distal Radius Fracture - Treatment Comparison

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

This is a prospective multi-site study. Subjects with distal radius fractures will be enrolled. Subjects will be treated surgically with a Sonoma WRx™ device or managed non-operatively with a splint or cast. Subjects will be enrolled in each group according to physician's standard of care (either casting/splinting or surgery) for distal radius fractures. Subjects will be enrolled based on the study's inclusion/exclusion criteria with a final qualifying decision made by a group of three independent adjudicators. The final qualifying review should allow for similar patient groups within each arm of the study due to the variability that can arise in fracture classification. Review by the adjudicators should be completed within 1 week.

NCT ID: NCT01871519 Completed - Cancer Clinical Trials

Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs

EVOLVE
Start date: May 2013
Phase: N/A
Study type: Interventional

The study objective is to collect and report 12-month outcomes pertaining to activities of daily living, quality of life, and safety parameters in a Medicare population to be treated with balloon kyphoplasty in the treatment of painful, acute, vertebral body compression fractures (VCFs) associated with either osteoporosis or cancer. The primary objective is to show statistically significant improvement from baseline in the four co-primary endpoints (SF-36v2, PCS, EQ-5D, NRS back pain and ODI) at 3-months; study success will be declared if the primary objective is met. New radiographic fractures, non-surgical management received, VCF-related healthcare resource utilization, and vertebral body height restoration data will also be collected.

NCT ID: NCT01869322 Completed - Clinical trials for Fracture of Shaft of Humerus

Acute Management of Humeral Shaft Fractures: Sling vs. Splint

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

When people break their arm and arrive at Oregon Health and Science University's Emergency Department (OHSU ED), they are treated with a short-term means of immobilizing their broken arm. The two most common ways of stabilizing the broken parts of the arm are 1) with a plaster-based coaptation splint, or 2) with a soft cloth sling and swathe. These hold the arm steady until the patient can schedule an appointment with the OHSU Orthopaedic Trauma clinic where they will receive definitive evaluation and stabilization/fixation. In much of the orthopaedic literature coaptation splints are the default immobilization method. The investigators hypothesize however, that sling and swathe immobilization may be equally effective for short term stabilization, while being faster to apply, and more comfortable for the patient. This randomized, unblinded prospective study will follow the satisfaction, quality of life and limited functional outcomes of all enrolled participants during the first week following their injury.

NCT ID: NCT01864785 Recruiting - Clinical trials for Thoracolumbar Burst Fracture

Comparison of Posterior Fixation Alone and Combined With Articular Process Fusion in Thoracolumbar Burst Fractures

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

Nearly 90% of all spinal fractures occur in the thoracolumbar region, and burst fractures are composed of 15% of such injuries. But the treatment of thoracolumbar fractures remains controversial. Treatment varies from the conservative management to various types of surgery. Internal fixation with spinal fusion is a surgical treatment method that is generally accepted for patients with thoracolumbar fracture. In this department, the investigators treat thoracolumbar burst fracture with posterior fixation alone and combined with articular process fusion. To evaluate the result of the two kinds of treatment, the investigators design this clinical trial. So, the investigators compared the radiological and clinical outcomes between patients who underwent posterior fixation alone and supplemented with fusion following the onset of thoracolumbar burst fractures.

NCT ID: NCT01859468 Terminated - Clinical trials for Distal Radius Fractures

A Study Comparing the Effect of Amorphous Calcium Carbonate (ACC) on Healing Time of Distal Radius Fractures

Start date: June 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Amorphical has a strong basis to believe that the Amorphous Calcium Carbonate (ACC) product has an effect on active mineralization during bone remodelling hence, it has a potential to accelerate fracture healing process. The active mineralization can most probably be attributed to the mineral component of this substance. The distal radius fracture was chosen as the model to test the effects of ACC treatment because it includes both trabecular and cortical bone, is accessible for radiographs, has little soft tissue that can distort the radiograph, and is amenable to multiple functional endpoints. Primary objective: To assess the efficacy of treatment with calcium from ACC compared to placebo on radiographic healing time in subjects with distal radius fractures. Secondary objectives: - To evaluate the effect of ACC compared to placebo on the improvement in wrist functional outcome following distal radius fracture. - To evaluate the safety profile of ACC in this population

NCT ID: NCT01851031 Completed - Clinical trials for Fracture of Condylar Process

A New Surgical Approach to Treat Medial or Low Condylar Fractures

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

The aim of the study was to compare the new approach and the retromandibular approach, so that the therapeutic effect and the advantages of the new approach would be clear.

NCT ID: NCT01850251 Terminated - Hip Fractures Clinical Trials

Effects of a Supplement Enriched in Hydroxymethylbutyrate and Vitamin D on Muscle Strength in Hip Fracture

Start date: June 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether a nutritional supplement high in protein and energy, and enriched with hydroxymethylbutyrate (HMB) and vitamin D is more effective than a standard nutritional supplement high in protein and energy in improving muscle strength in elderly patients with hip fracture.

NCT ID: NCT01847898 Completed - Clinical trials for Vertebral Body Fractures

Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting

Start date: September 1, 2009
Phase: Phase 4
Study type: Interventional

This is a randomized, controlled study to document and evaluate the clinical performance of the Vertebral Body Stenting (VBS) System in osteoporotic fractures of the thoracic and lumbar spine. The randomized, controlled trial (RCT) will compare patients with VBS and Balloon Kyphoplasty.

NCT ID: NCT01847508 Completed - Humerus Fractures Clinical Trials

PHILOS Augmented - a Multicenter Randomized Controlled Trial

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

The primary objective is to compare the mechanical failure risks in the first year after treatment.