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Fractures, Bone clinical trials

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NCT ID: NCT03367169 Terminated - Fractures Clinical Trials

Surgery of the Pilon Fractures

MICOPIL
Start date: November 23, 2017
Phase: N/A
Study type: Interventional

The assessment consists in comparing the osteosynthesis plate with minimally invasive technique versus open reduction and internal fixation. The aim of study is to compare (period of bandage, efficacy, safety), these two types of surgical technique by using a prospective, randomized analysis.

NCT ID: NCT03359941 Terminated - Fractures, Bone Clinical Trials

Acupuncture Treatment for Vertebral Compression Fracture

Start date: February 1, 2016
Phase: N/A
Study type: Interventional

Patients with vertebral compression fractures (VCF) may experience pain, limitation of daily activities, and various complications (e.g., insomnia, constipation, urinary infection, depression, diminished quality of life). Objective: This study aims to evaluate the effectiveness, safety and feasibility of acupuncture treatments to achieve pain relief and functional recovery in patients with VCF.

NCT ID: NCT03259906 Terminated - Clinical trials for Distal Intra-articular Radius Fracture With a Dorsal Tilt

Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate

PAPPO
Start date: January 2017
Phase: N/A
Study type: Interventional

For les intra-articular fractures, plate osteosynthesis is the indicated technique. Despite the absence of consensus, in recent years, the use of open reduction associated with internal plate fixation has considerably developed. Indeed, this therapeutic option allows a more anatomical reduction and stable fixation. First-generation posterior plates presented complications related to the size of the plate, notably tendon lesions. Over the last ten years, a new generation of thinner anterior plates has reduced these complications. In the literature, few studies have compared these two techniques in terms of functional and radiological outcomes. The hypothesis of this research is that osteosynthesis using a posterior plate is more effective than that with an anterior plate in terms of functional recovery in patients older than 45 years.

NCT ID: NCT03196258 Terminated - Pain, Postoperative Clinical Trials

Cognitive Behavioural Therapy to Reduce Persistent Post-Surgical Pain After Fracture

SPOC_CBT
Start date: October 1, 2018
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. In order to study this relationship, researchers at McMaster University have developed the Somatic Pre-Occupation and Coping (SPOC) questionnaire, which identifies illness beliefs that may help to predict which patients are at risk for ongoing pain, reduced quality of life, and delays in returning to work and leisure activities after a fracture requiring surgical treatment. Previous research using the SPOC questionnaire suggests the possibility that fracture patients with illness beliefs that put them at risk for developing ongoing pain could be identified early in the treatment process. These patients may benefit from 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 is effective in reducing ongoing pain and improving quality of life in fracture patients who show illness beliefs that may place them at risk for developing ongoing pain.

NCT ID: NCT03097757 Terminated - Ultrasound Clinical Trials

Trial of Ultrasound Guidance for Reduction of Pediatric Forearm Fractures

Start date: January 24, 2017
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess the utility of ultrasound guidance in the closed reduction of pediatric forearm fractures in the pediatric emergency department. The investigators will compare post-reduction radiologic outcomes between the experimental group (ultrasound guided closed forearm fracture reduction) and control group (standard of care blinded closed forearm fracture reduction) to determine if there is a difference in the number of adequate reductions between groups. Secondary objectives include comparing provider satisfaction with the reduction procedure, number of patients requiring repeat reductions, time for reduction, number of patients requiring operative repair after reduction, with the reduction procedure and comparison between post-reduction ultrasound and x-ray interpretation.

NCT ID: NCT03061279 Terminated - Clinical trials for Medial Malleolus Fractures

Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is assess the safety and efficacy of Acutrak headless screws in comparison to other fixation methods (traditional headed screws, plates, and wires) used in the treatment of medial malleolus fracture of the ankle joint. The investigators hope to learn the following objectives from this study 1. Prospectively establish equivalence with respect to fracture union rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 2. Prospectively establish equivalence with respect Patient Reported Outcome Measurement Information System (PROMIS) scores after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 3. Prospectively establish superiority with respect to hardware related pain after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 4. Prospectively establish superiority with respect to the hardware removal rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. Patients scheduled for open reduction and internal fixation for medial malleolus fracture by using Acutrak headless screw or any other method will be asked to enroll by the attending physician, and those patients will be asked to consent to the study. Patients will be randomized by sealed envelope to surgical fixation with traditional headed screws, plates, and wires or Acutrak headless compression screws. At the time of randomization, the fracture pattern and severity, past medical history and medications, and demographic data will be documented. After operative fixation, patients will receive routine fracture follow-up with a clinical evaluation for tenderness, radiographs to evaluate stability and union, and complete the PROMIS and Visual Analogue Pain Scale (VAS) scores to 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgical fixation

NCT ID: NCT03042546 Terminated - Clinical trials for Open tíbia Fracture With Sub-segmental Bone Loss

Calcium Sulfate Spacer in Open Tibia Fractures

Start date: February 1, 2017
Phase: Phase 4
Study type: Interventional

Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.

NCT ID: NCT03042533 Terminated - Clinical trials for Closed Transverse Fracture of Shaft of Tibia

Union Rate of Transverse Tibia Fracture

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

The investigators will compare the three methods of seating a tibial nail - Backslapping or Backslapping with Dynamic Locking or Internal Compression.

NCT ID: NCT03017105 Terminated - Clinical trials for Proximal Humerus Fractures (to be Managed Non-operatively)

Cross-education for Proximal Humerus Fracture Rehabilitation

Start date: January 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Proximal humerus fractures (break of the top part of the upper arm bone) are common in older people with poorer bone quality. Often patients do not undergo surgery for these fractures: the bone fragments may be in an acceptable enough position to be able to heal naturally, or the patient may not be well enough medically to undergo an operation. These patients need to wear a sling to immobilise their injured shoulder, however muscles start to weaken quickly when they are unable to be used. This research project will look at whether strength-training the opposite/uninjured limb, known as "cross education", has any effect on preserving the function of the injured/fractured limb. Participants will be randomised into two groups using minimisation, that is to say the groups will have balanced numbers in terms of exact pattern of fracture and gender. One group will receive traditional rehabilitation exercises and treatment by the physiotherapist for their injured limb; the other group will receive the same but in addition will also undergo a strength-training exercise programme for their uninjured limb. Only qualified physiotherapists with experience of treating this patient cohort will be involved. Sessions in the physiotherapy department will last up to 30 minutes each and will comprise of: patient review, exercise progression, and advice giving/question answering; home exercise programmes will be expected to be completed 2-3 times daily and last up to 30 minutes each; number of sessions will be agreed between the participant and treating physiotherapist with treating ending once an agreed, acceptable level of function has been achieved. The Oxford Shoulder Score patient-reported outcome measure will be completed by the participant at 6 and 12 weeks and the European Quality of Life (EuroQoL)-5D-5L at 12 weeks after commencement of treatment.

NCT ID: NCT02972294 Terminated - Anemia Clinical Trials

HiFIT Study : Hip Fracture: Iron and Tranexamic Acid

HiFIT
Start date: March 31, 2017
Phase: Phase 3
Study type: Interventional

Fractures of the upper end of the femur, called commonly "Hip fractures" are very common, with an incidence of approximately 1.6 million cases per year worldwide. This high incidence is anticipated to grow rapidly in the next decades, driven by population aging. Anemia is very frequent on admission for hip fracture, concerning up to 45% of the patients, with a mean hemoglobin level of 12.5±0.2 g/dl. This high prevalence of anemia together with blood losses, secondary to the fracture itself and surgery are responsible for a high rate of blood transfusion (approximately 40-50% of the patients). However, both anemia and blood transfusion are associated with poor outcome, including increased mortality, length of stay, infection rate etc. In addition, blood is a scarce and expensive resource and its use should be limited as much as possible. There is therefore a need to treat this anemia and/or to prevent the decrease in hemoglobin. For this purpose, intravenous iron has been proposed. Some non-randomized, mainly retrospective, studies have shown that perioperative intravenous iron was able to reduce blood transfusion (i.e. the number of patients transfused and the number of units per patient). Another way to reduce blood transfusion would be to reduce perioperative bleeding. Tranexamic acid has proven to be efficient for this purpose both in trauma patients and in elective surgery patients.The interest for perioperative blood management has recently increased thanks to better recognition of the adverse effects of blood transfusion, better understanding of iron metabolism, new intravenous iron drugs and a renewed interest in former medications (i.e. tranexamic acid). HiFIT study therefore propose a 2X2 factorial design for this study in order to answer questions vis-à-vis the interest of iron and tranexamic acid to reduce blood transfusion in hip fracture patients.