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Humeral Fractures clinical trials

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NCT ID: NCT05668182 Recruiting - Femoral Fracture Clinical Trials

A Case Series: TRUMATCH Graft Cage for Segmental Long Bone Defects

Start date: June 29, 2021
Phase:
Study type: Observational

This project consists of a prospective case design. Study candidates will include all patients ages 18 and over who were evaluated at UCSD and found to have a critical-sized humerus, femur, or tibia segmental defect that would be fixed through surgery. Patients who consent to study participation will receive the TRUMATCH Graft Cage for their long bone segmental defect repair. Data on healing rates, complication rates, re-operation rates, time to return to normal activity, and pain levels will be collected for each participation. After 3 years of data collection, we will analyze this data to provide further insight on the utility of the TRUMATCH Graft Cage. Given the significant difficulty with repairing segmental long bone defects, it is imperative to evaluate novel systems to appropriately manage these injuries.

NCT ID: NCT05602077 Recruiting - Elbow Fracture Clinical Trials

Accuracy of Sonography in Elbow Trauma

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

X-rays (XR) are today the standard modality for the diagnosis of bone fractures in the lower or upper limbs in the emergency room. Point-of-care ultrasound (POCUS) is an alternative with some obvious advantages especially in the emergency room setting: It does not require the patient to fix the bone of interest in a stable position, allows observing the bone and joints under movement by the patient, can be performed at bedside, and avoids the exposure to radiation. The advances in ultrasound technology has increased the interest in using POCUS as an alternative to XR in recent years. POCUS is used routinely prior to XR at the ORTHO-NOTFALL of the Merian Iselin Klinik Basel (MIK) in patients with suspicion for an indirect elbow trauma. It is the aim of this project to use this constellation in order to contribute to a systematic comparison of the value of the two modalities with the long-term aim to establish POCUS as the first-line diagnostic tool. As a fist project, the SONOELB study was initiated. This study aims at a comparison of the diagnostic accuracy between XR and POCUS using CT as reference. The project started in October 2022 and aims at enrolling 130 patients until March 2025. The project is financially supported by the Merian Iselin Science Research PLC.

NCT ID: NCT05437822 Recruiting - Clinical trials for Proximal Humeral Fracture

Tranexamic Acid in Proximal Humeral Fractures

Start date: June 29, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the effect of tranexamic acid (on blood loss and transfusion requirements in patients with proximal humeral fractures requiring open surgical approaches. This a blinded, controlled, therapeutic trial in which the patients will be randomized to receive TXA or no drug intervention. The primary outcome is the estimated total blood loss. This study presents only minimal risks for the included patients.

NCT ID: NCT05351112 Recruiting - Clinical trials for Proximal Humerus Fracture

PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder 2.0 Fracture System

Start date: July 7, 2022
Phase:
Study type: Observational

The study is a multicenter, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder 2.0 Fracture System (Implants and Instrumentation) when used for fracture shoulder arthroplasty. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.

NCT ID: NCT05256849 Recruiting - Humeral Fracture Clinical Trials

Treatment of Humeral Fractures With Long PHILOS Plates Using a Modified Technique and Approach Avoids Radial Nerve Palsy

Start date: January 6, 2022
Phase:
Study type: Observational

Radial paralysis is a well-known complication of plate osteosynthesis on the humeral shaft. At the University Hospital Basel, these fractures have been treated in an adapted procedure with long PHILOS plates using a modified technique and approach. This study is to retrospectively analyze the effectiveness of the surgical technique in relation to iatrogenic radial paralysis.

NCT ID: NCT05143476 Recruiting - Humerus Fractures Clinical Trials

Serum-Protein-Based Indices for the Progression of Fracture Healing and Nonunion

UNION
Start date: June 26, 2021
Phase:
Study type: Observational

To define a serum protein-based diagnostic for the progression and failure of fracture healing, through the identification of a set of serum proteins that appear at early times of biological healing and show a specific correlation with later radiological and functional signs used to define delayed healing and non-union.

NCT ID: NCT05118087 Recruiting - Humeral Fractures Clinical Trials

Comparison of Bracing With Co-aptation Splinting for the Initial Treatment of Acute Humeral Shaft Fractures: The COBRAS Trials

Start date: July 20, 2021
Phase: N/A
Study type: Interventional

The goal of this study is to determine which initial method of immobilization for humeral shaft fractures in the emergency room maximizes patient comfort. The two methods of initial management for humeral shaft fractures are sarmiento bracing (pre-fabricated fracture brace) and coaptation splinting. In this study, the team will compare patient related outcomes and comfort for each method of initial management of humeral shaft fractures. Participant pain, narcotic usage, and function will be tracked over a 2 week period to see which method of immobilization is preferred.

NCT ID: NCT05084573 Recruiting - Shoulder Fractures Clinical Trials

Continuous Interscalene Block vs Liposomal Bupivacaine After Proximal Humerus Fracture Surgery

CLIP-H
Start date: August 1, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of continuous interscalene block (CISB) using standard bupivacaine versus a single interscalene injection of liposomal bupivacaine (LB) on pain control following surgical fixation of proximal humerus fractures.

NCT ID: NCT05019664 Recruiting - Humeral Fractures Clinical Trials

Affixus Natural Nail System Humeral Nail PMCF

Start date: August 29, 2022
Phase: N/A
Study type: Interventional

A commercially available product clinical study which aims to confirm the safety, performance and clinical benefits to the patient of the Affixus Natural Nail upper arm (humerus) bone nail system for both the implant itself and the instrumentation used during surgery.

NCT ID: NCT05005364 Recruiting - Clinical trials for Proximal Humerus Fractures

Prospective Evaluation of the Clinical Profile and Treatment Outcomes of Proximal Humerus Fractures.

SPHEER
Start date: August 21, 2017
Phase:
Study type: Observational

With an ageing population, fragility fractures secondary to osteoporosis are on a increasing trend. Proximal humerus fractures are common fractures which account for a significant proportion of these fragility fractures. They significantly affect patients function and independence particularly in the elderly. Currently, treatment options range from conservative treatment with an arm sling to fixation either with plates or intramedullary devices to arthroplasty ranging from a hemiarthroplasty to the latest reverse shoulder arthroplasty. While is there has been a global trend towards surgical treatment for such fractures, there is significant controversy regarding the best treatment with many studies reporting disappointing functional outcomes including residual shoulder pain, limitation in shoulder motion and decreased quality of life regardless of treatment option selected. In this day and age where healthcare cost is a big concern both at the individual patient level but at a government level as well, evaluating the cost effectiveness of treatment becomes essential as well. Currently in Singapore, there have been a significant trend of an increased use of surgical treatment of proximal humerus fractures however we have very little data in our local context not only to evaluate the clinical effectiveness but also the cost effectiveness of surgical treatment in comparison to conservative treatment. The primary aim of the study is 1. To understand the epidemiology and prognostic factors for proximal humerus fractures - Incidence - Health service utilization - clinical and functional outcomes 2. To estimate the relative cost-effectiveness of surgical vs non-surgical treatment pathways for managing patients with proximal humerus fractures. We hypothesize that surgical fixation of the proximal humerus is both clinically and cost effective