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Fractures, Bone clinical trials

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NCT ID: NCT02461810 Completed - Osteoporosis Clinical Trials

Prospective Comparative Study to Compare Safety and Effectiveness of Two Vertebral Compression Fracture Reduction Techniques

SAKOS
Start date: April 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus Balloon Kyphoplasty.

NCT ID: NCT02458547 Completed - Hip Fracture Clinical Trials

Effect of Anesthesia Technique on Outcome After Hip Fracture Surgery in Elderly Adult Patients

Start date: May 2015
Phase: N/A
Study type: Interventional

Despite many previous studies, whether anesthetic technique will significantly affect overall patient outcome, morbidity and mortality in elderly hip fracture patients is controversial. Due to old age, poor patient condition and emergent clinical settings, patients undergoing surgical procedures for hip fracture management are often subject to poor postoperative outcome and high mortality rates. While many studies have reported that regional anesthesia leads to improved postoperative outcome after hip fracture surgery, others have concluded otherwise. Moreover, because the majority of these previous studies are retrospective cohorts or systemic reviews, there is a need for randomized clinical trials to provide high quality evidence. This study aims to compare patient outcome between three different anesthetic techniques in elderly patients undergoing surgery for hip fracture management by evaluating proinflammatory cytokines, chemistry lab testing and clinical outcome between general anesthesia with either desflurane or propofol-based TIVA and spinal anesthesia with bupivacaine.

NCT ID: NCT02456415 Completed - Hand Fractures Clinical Trials

The Efficacy and Safety of Magnesium Alloy Screw as a Novel Bioabsorbable Material in Patients Due to Hand Fractures

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

This study evaluates the safety and efficacy of biodegradable magnesium alloy screw, in patients with hand fractures who require internal fixation (to obtain a product license from the Ministry of Food and Drug Safety in Korea (MFDS)).

NCT ID: NCT02456194 Completed - Tibial Fractures Clinical Trials

Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial

Start date: September 2015
Phase: N/A
Study type: Interventional

This is a prospective clinical trial of tibial plateau fractures treated with internal fixation and a calcium sulfate graft which can be mixed with antibiotics and molded into various bead sizes for implantation into bone defects. The graft material chosen for this study is STIMULAN Rapid Cure (Biocomposites, UK), which is approved for use as a bone void filler and may be mixed with a variety of antibiotics. The combination of STIMULAN + antibiotic in bead form is the "study device". Our primary study aim is to look at resorption and remodeling of the study device into bone. Another important aim of the study is to look at subsidence, or collapse, of the joint surface.

NCT ID: NCT02450045 Terminated - Hip Fractures Clinical Trials

Pre-op Femoral Nerve Block for Hip Fracture

Start date: June 2015
Phase: N/A
Study type: Interventional

Hip fractures (broken hips) are common in older people, particularly older women with fragile bones, and usually occur with a simple fall from a standing height. In Canada, over 28,000 hip fractures occur every year, and approximately 900 occur in Edmonton. After a hip fracture, up to 50% of those who survive their hip fracture do not recover to the same level of activity that they had before breaking their hip. Managing pain with any broken bone is very important. For patients with hip fracture, their older age and fragile health makes pain management even more challenging. Many patients with a hip fracture have reduced ability to think clearly before the fracture. Some patients who have no difficulty with thinking before their hip fracture will become confused for a brief period after their hip fracture or can develop permanent difficulties with thinking. A hip fracture will usually require an operation, and choosing the right pain medication before and after the operation is important since many pain medications make confusion more likely. Permanent difficulty with thinking is a common reason for poor recovery after hip fracture. Our study will look at use of a nerve block to manage pain before patients have their operation. A nerve block provides local pain relief without requiring patients to take the medication by mouth (oral) or through an intravenous (IV) route. A nerve block before surgery may reduce the amount of oral and IV pain medication needed by the patient both before and after their operation but still provide good pain control with less confusion. This could lead to better recovery and allow more patients to return to living in the community rather than long-term care.

NCT ID: NCT02449096 Recruiting - Ankle Fractures Clinical Trials

Comparison of the Results of Complex Ankle Fractures Treated With and Without Ankle Arthroscopy

Start date: July 2015
Phase: N/A
Study type: Interventional

Background: An anatomical reconstruction of ankle congruity is an important prerequisite in the operative treatment of acute ankle fractures. But, despite an anatomic reduction, patients suffer from residual problems like chronic pain, stiffness, persistent swelling and instability after these fractures. There is growing evidence, that this poor outcome is related to the concomitant traumatic intraarticular pathology. Therefore, supplementary ankle arthroscopy has been proposed in acute ankle fractures as it is a valuable tool to confirm the anatomic reposition and to further identify and manage associated intraarticular injuries. The arthroscopic treatment of these pathologies might result in a better outcome after complex ankle fractures. Nevertheless, until now, the vast majority of ankle fractures are managed by open procedures only. Still, indications for arthroscopically assisted open reduction and internal fixation (AORIF) are not clearly stated, and the effectiveness of AORIF compared with open reduction and internal fixation (ORIF) has not yet been determined for complex ankle fractures. In this context, only a prospective randomized study can sufficiently answer these open questions. Therefore, the investigators plan a randomized controlled trial intended to report the short-, midterm- and long-term follow-up of patients who underwent operative treatment of acute ankle fractures - with and without ankle arthroscopy. Methods/Study design: The investigators will perform a randomized controlled trial evaluating the effect of AORIF compared to ORIF with a sample size of 40 patients per group. The investigators include patients with an acute ankle fracture after written informed consent. Primary outcome of the investigators' study is the difference of the AOFAS score (American Orthopedic Foot and Ankle Society) between the intervention (AORIF) and comparison (ORIF) group after a follow-up of 2 years. Several secondary outcome parameters will be assessed as well. Statistical analysis will be performed using a two-sided Student`s t-test. Discussion: Until today, there are only two randomized controlled trials evaluating the effect of open reduction and internal fixation (ORIF) compared to arthroscopically assisted open reduction and internal fixation (AORIF). Both studies only included patients with isolated fractures of the distal fibula at the level of the syndesmosis. These are the most simple fractures that are regularly treated operatively. Both studies documented a high incidence of intraarticular disorders in the AORIF group, but only one could show significant better results in the AORIF group. Moreover, several other studies could consistently demonstrate that the intraarticular damage is even more pronounced the more complex the fracture is. Consequently, a more distinctive effect of arthroscopy in complex fractures involving two malleoli or more has to be assumed when compared to these simple fractures.

NCT ID: NCT02448849 Recruiting - Bone Fracture Clinical Trials

Autologous BM-MSC Transplantation in Combination With Platelet Lysate (PL) for Nonunion Treatment

Start date: June 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Nonunion of long bones would occur in almost 10% of fractures and because of its long term and complicated treatment, is known as a therapeutic challenge for both of the surgeons and patients. Cell therapy is useful in treatment of nonunion and mesenchymal stromal/stem cells are the best candidates for this kind of treatment. Percutaneous implantation of autologous bone marrow derived mesenchymal stromal/stem cell in combination with PL will be done in 30 patients with tibia nonunion. The other 30 patients as the control group will receive placebo. The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation. The Spss(v16) software will be used for data analysis.

NCT ID: NCT02446470 Active, not recruiting - Clinical trials for Intra-articular Fractures

Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures

Start date: May 2015
Phase: N/A
Study type: Interventional

This study is a prospective, randomized controlled trial comparing the sinus tarsi approach to the extensile lateral approach for surgical fixation of calcaneus fractures. It is hypothesized that open reduction and internal fixation of intra-articular calcaneus fractures using a sinus tarsi approach will provide equivalent fracture reduction and stable fixation with significantly decreased wound complication rates in comparison to an extensile lateral approach.

NCT ID: NCT02444468 Recruiting - Ankle Fractures Clinical Trials

Preoperative Treatment of Malleolar Fractures

Start date: March 2015
Phase: N/A
Study type: Interventional

This study investigates, in a randomized setting, the use of intermittent in-cast pneumatic foot-compression (IPC) in the preoperative treatment of malleolar fractures. This is to investigate whether the IPC has any effect on preventing swelling of the ankle, and thereby preventing delay of surgery due to swelling. The investigators will include patients with malleolar fractures that require surgery in two groups, IPC and bandage or bandage only, and measure the time from diagnosis-to-surgery.

NCT ID: NCT02441790 Withdrawn - Fracture Clinical Trials

Early Range of Motion in 5th Metacarpal Fracture

Start date: May 2015
Phase: N/A
Study type: Interventional

Fractures of the fifth metacarpal neck are the most common injury involving the upper extremity. Patients are typically young adult males. Restoring function quickly and reliably for return to work and/or activity is important; these patients are a significant labour force demographic. Treatment is historically splinting for approximately 3-4 weeks. Splinting a fracture is a "trade-off". Immobilization allows stabilization and fracture healing, but also causes hand stiffness and weakness leading to impaired function. Little prospective research exists; there is no agreement for ideal duration of splinting or therapy, demonstrating clinical equipoise. A new concept in hand rehabilitation is "early active range of motion" (EAROM). The objective of this trial is to establish if EAROM provides improved early (6 week) hand function when compared to standard immobilization.