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Fractures, Bone clinical trials

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NCT ID: NCT05571449 Recruiting - Clinical trials for Tibial Plateau Fracture

Efficacy of the Use of 3D Printing Models in the Treatment of Tibial Plateau Fractures: a Randomized Clinical Trial

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

TIBIA3D is a randomized, open and prospective clinical trail that evaluates the use of preoperative 3D printing in the surgical treatment of patients with tibial plateau fractures

NCT ID: NCT05559736 Recruiting - Clinical trials for Femoral Neck Fractures

Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

Start date: May 24, 2023
Phase: N/A
Study type: Interventional

In February 2021, Altior Trauma Innovations™ announced that it had received 501(k) FDA approval for the Artemis Proximal Femoral Nail (PFN) System for internal fixation of intertrochanteric femur fractures. The objective of this pilot study is to evaluate safety, efficacy and feasibility of the Artemis PFN implant for operative fixation of intertrochanteric femoral fractures, compared to matched historical control patients who received other implants.

NCT ID: NCT05557344 Recruiting - Pain Clinical Trials

Oral vs IV Acetaminophen for Long-bone Fracture in Children

Start date: April 21, 2021
Phase: Phase 4
Study type: Interventional

Intravenous (IV) acetaminophen entered the Canadian market recently and children with acute pain following a trauma are ideal candidates for the IV formulation as it may improve analgesia and consequently decrease the amount of opioids needed to achieve pain control. Due to the limited data on bioavailability, adverse effect profile and efficacy of IV versus oral acetaminophen, it is of paramount importance to generate evidence-based data to guide clinicians with a rational choice of route of administration of acetaminophen. Therefore, we propose a pilot study to inform a future large randomized controlled trial (RCT) to compare pharmacokinetics, feasibility, preliminary effects and side effects profile of oral versus IV acetaminophen in children admitted for surgical fixation of a long-bone fracture.

NCT ID: NCT05555459 Recruiting - Hallux Valgus Clinical Trials

Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation

Start date: September 28, 2022
Phase: N/A
Study type: Interventional

The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The study recruits 125 adult patients who meet the acceptance criteria. The follow-up time for each study patient is 4 years. The study is a single center single group study which is conducted in Tampere University Hospital (TAYS) in Finland. The main focus of the study in terms of performance is to evaluate the bone healing/ossification of operated areas. The main focus of the study in terms of safety is to evaluate the occurrence of adverse events and required revision surgeries that are or might be related to the study device.

NCT ID: NCT05538403 Recruiting - Fracture Clinical Trials

AI Performance for the Detection of Bone Fractures in Children

Start date: May 1, 2022
Phase:
Study type: Observational

The artificial intelligence (AI) software BoneView (GLEAMER Company, Paris, France) has been designed, tested and validated to detect and locate recent or semi-recent fractures on standard radiographs. The objective will be to assess the AI performance for the detection of bone fractures in children aged less than 2 years old in suspected child abuse setting. These patients benefit from a whole body radiography with a double blind reading by a "generalist" radiologist and a radiologist with expertise in child abuse. This readings will be compared with the AI results. Hypothesis is that AI is effective for child fractures detection and could be of help especially for radiologists who are not experts in child abuse.

NCT ID: NCT05536622 Recruiting - Fractures, Bone Clinical Trials

Hi-Res IR Thermography for the Diagnosis of Toddler's Fractures

Start date: February 11, 2021
Phase: N/A
Study type: Interventional

This is a pilot proof of feasibility study to explore the efficacy of high resolution thermal imaging (HRTI) to screen for toddler's fractures. In HRTI, a sensitive thermal camera is used to capture the temperature profile of the suspected fracture region and then analyse and interpret the information using image processing. Toddler's fractures are a common type of tibial fracture in children under 5 years old that can be particularly difficult to detect as the bone typically appears normal on x-ray for the first 10 days and becomes detectable thereafter only as new bone forms. The child's leg is put in plaster in the interim and the diagnosis cannot be confirmed until 10-14 days later. Around 60% of children with suspected toddler's fracture will not have a fracture, and would therefore have had plaster, repeat attendances and repeat x-ray unnecessarily. There is also the inconvenience and general risks of plaster immobilisation for the child. In an earlier study, the investigators demonstrated that HRTI has potential in diagnosing limp in children. This study included two children with toddler's fracture where HRTI detected the fracture's location on the patient's first Emergency Department(ED) visit. In this study, the investigators aim to build on earlier work to explore HRTI for screening for toddler's fracture. On its successful completion, the investigators aim to develop the technology in a follow on larger diagnostic study as a tool that could be used to quickly exclude cases where the injury has not resulted in a fracture. This would allow more objective decision making during the initial assessment of the child. In addition, a reduction in the number of unnecessary x-rays, revisits, treatment as well as cost is anticipated.

NCT ID: NCT05530174 Recruiting - Clinical trials for Total Hip Arthroplasty

Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture

ProHipQ-F
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Aim: To compare the effect of one single dose versus multiple doses of prophylactic antibiotics administered within 24 hours, on the development of PJI after surgery in patients undergoing primary THA due to an acute fracture or sequelae of proximal femoral or acetabular fractures. The study is designed as a cross-over, cluster randomized, non-inferiority trial. All Danish orthopedic surgery departments performing primary THA with the majority being within inclusion criteria will be involved: Based on national quality databases, two-year cohorts of approximately 2,000 primary THAs due to a fracture or sequelae to a fracture, conducted at all public and private orthopedic departments in Denmark, this includes 36 sites corresponding to a total of 39 departments.

NCT ID: NCT05528432 Recruiting - Fractures Bone Clinical Trials

ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures

Start date: February 1, 2021
Phase:
Study type: Observational

To investigate the diagnostic value of ultrasound performed by a lay experimenter compared to standard radiographic imaging (or standard x-ray) in the detection of fractures in patients with closed acute ankle trauma and positive Ottawa ankle rules

NCT ID: NCT05521724 Recruiting - Vertebral Fracture Clinical Trials

Osteoporotic Vertebral Fractures and Exercise

Start date: August 20, 2022
Phase: N/A
Study type: Interventional

Physiotherapy has an important place in the treatment of osteoporotic vertebral fractures. Therapeutic exercise is often recommended for patients with vertebral fractures to reduce pain and restore functional movement. There is not enough evidence in the literature to determine the effects of long-term exercise on osteoporotic fractures and their side effects. Therefore, the aim of this study is to evaluate the effectiveness of 12-week exercise training in patients with osteoporotic vertebral fractures.

NCT ID: NCT05519332 Recruiting - Clinical trials for Osteoporotic Fracture of Vertebra

Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compression Fractures

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

Purpose: To compare the clinical outcomes and radiological parameters of patients undergoing percutaneous vertebroplasty (PVP) versus those undergoing percutaneous vertebral-disc plasty (PVDP) for back pain, segmental instability, and kyphosis due to thoracolumbar very severe osteoporotic vertebral compression fractures (vsOVCFs). This prospective study included elderly patients with thoracolumbar vsOVCFs. All the patients were randomly allocated into the PVP group (who underwent conventional PVP) and the PVDP group (who underwent PVP combined percutaneous cement discoplasty). The visual analogue scale (VAS), Oswestry Disability Index (ODI), local kyphosis angle, and disc height were recorded preoperatively and postoperatively.