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Fractures, Bone clinical trials

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NCT ID: NCT03682328 Not yet recruiting - Clinical trials for Osteoporotic Fracture of Vertebra

Vertebroplasty and Kyphoplasty in Osteoporotic Vertebral Body Fractures.

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Vertebral body fractures are a major health care problem in all countries with incidence 1.4%. They are a common cause of severe debilitating pain, with consequent deteriorated quality of life, physical function and psychosocial performance. Surgery is indicated in patients with vertebral body fracture, and concurrent spinal instability or neurologic deficit. The cornerstone of management for vertebral body fractures without neurological impairment is medical therapy, which include analgesics, bed rest, orthoses and rehabilitation. In the majority of patients such treatment modalities are effective. However, conservative management measures are not indicated for every type of fracture. For example, in older patients with vertebral fractures and cardio-respiratory disease it is not possible to prescribe bedrest for long period. Moreover, sometimes anti-inflammatory drugs are poorly tolerated by older patients, and bed rest can lead to further demineralization of the vertebrae, predisposing to future fractures. Percutaneous minimally invasive vertebral augmentation methods for cement application into the vertebral body are a useful tool for the management of symptomatic fractures without neurological impairment when conventional measures of treatment can not be adopted. Two different percutaneous minimally invasive vertebral augmentation methods for cement application into the vertebral body for the management of symptomatic vertebral body fractures without neurological impairment have been developed, namely vertebroplasty and kyphoplasty. Kyphoplasty and vertebroplasty have gained wide acceptance worldwide to manage patients without neurological impairment suffering from unmanageable pain caused by vertebral body fractures. Both procedures depend on mechanical stabilization of the fracture produced by cement injection into the fractured vertebral body. Cement augmentation of the vertebral body by vertebroplasty and kyphoplasty was originally introduced for osteoporotic compression fractures, but surgeons have now applied these techniques as a method of enhancing anterior column support while avoiding the morbidity and complications associated with anterior approaches. The mainstay of the controversy between kyphoplasty and vertebroplasty are height restoration, whether or not this height restoration is clinically significant, and the risks related to height restoration.

NCT ID: NCT03679481 Withdrawn - Clinical trials for Blood Loss Following Open Femur Fracture Surgery

The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery

Start date: April 1, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the effect of tranexamic acid (TXA) on blood loss and transfusion requirements in patients with femur fractures requiring open surgical approaches.

NCT ID: NCT03673865 Terminated - Orbital Fractures Clinical Trials

The Use of 3D Printing in Orbital Fractures

Start date: October 11, 2019
Phase: N/A
Study type: Interventional

The study is a prospective randomized longitudinal clinical study to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-D printer versus standard non-adapted orbital implants (the latter being the traditional approach and current standard of care).

NCT ID: NCT03673358 Terminated - Pain, Postoperative Clinical Trials

Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Pilot

COPE Pilot
Start date: January 9, 2019
Phase: N/A
Study type: Interventional

Psychological factors such as stress, distress, anxiety, depression, and poor coping strategies may be associated with ongoing pain following injuries such as fractures. To study this relationship, patients will undergo cognitive behavioural therapy (CBT) which is designed to modify such thoughts with the goal of reducing ongoing pain and improving quality of life. The goal of this study is to determine if CBT, versus usual care, reduces the prevalence of moderate to severe persistent post-surgical pain (PPSP) over 12-months post-fracture

NCT ID: NCT03670290 Completed - Hip Fractures Clinical Trials

Clinical Outcomes of Analgesia Methods in Patients With Hip Fracture

Start date: December 15, 2018
Phase:
Study type: Observational

The goal of this study is to determine of clinical outcomes of analgesia methods. The primary outcomes are opioid consumption, static and dynamic visual analog scale (VAS) scores. Secondary outcomes are occurrence of side effects.

NCT ID: NCT03666637 Completed - Avascular Necrosis Clinical Trials

Femoral Neck Fracture in Adult and Avascular Necrosis and Nonunion

Start date: September 15, 2017
Phase:
Study type: Observational

One of the most serious sequelae of femoral neck fractures (FNFs) is avascular necrosis (AVN) and nonunion, and this translates to a significant morbidity and mortality. This study was conducted to determine the relationship between the etiologies and management of FNFs in our institution and its relationship to the development of AVN or nonunion.

NCT ID: NCT03652753 Recruiting - Pilon Fracture Clinical Trials

Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)

Start date: January 1, 2019
Phase: Phase 4
Study type: Interventional

High energy intra-articular fractures of the distal tibia, or Pilon fracture, is a devastating injury with multiple short and long term complications. The incidence of these injuries is increasing as survival rates after motor vehicle collisions increase. The current standard of care for high energy pilon fractures is to place an external fixator at the time of injury and then provide definitive internal fixation when the soft tissue envelope allows, which is usually around 10-14 days. Arguably, the most debilitating long term complication after a high energy pilon fracture is the development of post-traumatic osteoarthritis (PTOA), which occurs in 50% or more of pilon fractures within the first 2 years of surgery. The development of osteoarthritis occurs even in the presence of adequate restoration of the tibial plafond. Part of this issue lies in the fact that ankle joint cartilage is the thinnest of any major articular joint and sustains a great deal of damage at the time of injury. This impaction and injury initiates a cascade of events that ultimately result in cartilage cell death, or chondrolysis. Chondrolysis occurs via necrosis or apoptosis. Apoptosis occurs via a caspase pathway, while necrosis of chondrocytes likely occurs secondary to overproduction of reactive oxidant species (ROS). Recent animal models have demonstrated several things: chondrocyte death is highest along fracture lines, and likely undergo necrosis as opposed to apoptosis. The reason that PTOA likely occurs in such a high percentage of pilon fractures is because of this chondrolysis, and if a method can be developed to decrease the rate of chrondrocyte necrosis, then the rate of PTOA could potentially improve and improve patient outcomes overall. A recent bovine model examined the injection of N-acetylcysteine (NAC) after an intra-articular knee fracture and its effect on the cartilage cell viability. Their study demonstrated that chondrocyte cell viability after an injection of NAC within four hours of injury decreased chondrolysis from roughly 60% to about 30% at 48hrs. The effect was greater the closer to injury the injection occurred, and was statistically significant for 2 weeks. This indicates that free radical scavengers can potentially improve cartilage cell viability and help prevent the development of PTOA. No studies have been published on humans regarding injection of NAC after a fracture. However, a recent article examined the injection of NAC into osteoarthritic knees and found that it was effective in lowering certain cartilage degradation markers and was comparable to hyaluronic acid for both pain and function. NAC has been proven safe for both intra-articular injections and systemic injections in humans. Our study will focus on the improvement of cartilage cell viability with an injection of NAC. Our hypothesis is that the NAC intra-articular injection will increase the percentage of viable cartilage cell after sustaining a pilon fracture, when compared to a placebo injection of saline. The goal of this study is to examine the effects of an intra-articular injection of the amino acid NAC on cartilage cells after an intra-articular fracture of the ankle joint. The long-term clinical goal of this research is to reduce the incidence of post-traumatic osteoarthritis in the ankle joint after fracture.

NCT ID: NCT03651804 Suspended - Facet Joint Pain Clinical Trials

Radiofrequency Ablation: Treatment for Posterior Element Pain From Vertebral Compression Fractures

Start date: April 10, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to test the efficacy of radiofrequency ablation of the medial branch nerves (RFA-MBN) in relieving pain and improving physical function in patients with subacute and chronic vertebral compression fractures (VCF).

NCT ID: NCT03648775 Terminated - Osteoporosis Clinical Trials

Evaluation of the Clinical Efficacy of Y-STRUT® Medical Device Implanted for Contralateral Percutaneous Internal Fixation of Proximal Femur, in Patient With a Low Energy Per Trochanteric Fracture on the First Side

Start date: December 6, 2017
Phase:
Study type: Observational

HIP50 is a national, multicentre, prospective, observational study, in patients presenting a first low energy per trochanteric hip fracture on one side and treated with Y-STRUT® device implanted on the contralateral proximal femur as percutaneous internal fixation to prevent contralateral hip fracture in case of osteoporosis. The primary objective of this study is to evaluate the clinical efficacy of the studied medical device by measuring the frequency of patient with a fracture at the implantation site within 1 year after implantation. A total of 50 patients from France will be enrolled (until December 2020) and followed up to 24 months.

NCT ID: NCT03646253 Completed - Clinical trials for Proximal Humerus Fracture

Analysis of Four-fragment Fractures of the Proximal Humerus: the Interest of 2D and 3D Imagery and Inter- and Intra-observer Reproducibility

REPROD-HUMERUS
Start date: June 1, 2016
Phase:
Study type: Observational

Fractures of the proximal humerus are increasingly frequent, with numbers tripling between the 1970s and the 2000s. Among these fractures, those involving the tuberosities and also the anatomic neck are a therapeutic challenge. For this type of fracture (Neer's four-part fracture) the degree of displacement of the fracture needs to be understood in order to provide suitable treatment and apprehend the risks in its evolution. There is indeed, in this type of fracture, a risk of humeral head ischaemia, which will carry considerable weight in the therapy adopted. The usual classifications, such as the AO or the Neer classification, have shown their limitations in terms of reproducibility and are not suitable for the prognostic assessment of these four-fragment fractures of the proximal humerus. The radiographic parameters described by Hertel in 2004, on the other hand, seem to be far more relevant to routine clinical practice. The use of the scanner to improve reproducibility of the classification of these proximal humerus fractures is still controversial. The scanner is the rule to guide therapeutic strategy for complex fractures, although the reproducibility of the different assessment criteria has never been studied.