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Humeral Fractures clinical trials

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NCT ID: NCT03097406 Active, not recruiting - Clinical trials for Proximal Humeral Fracture

Functional Outcome and Complications After Global Unite ® Prostheses

Start date: January 1, 2017
Phase:
Study type: Observational

This study aims to investigate the shoulder function of patients with osteoarthritis or a fracture of the upper extremity after surgery with the Global Unite shoulder system. The majority of fractures of the humerus are non-surgically treated, but for the complex cases where the fracture is irreparable (1), the treatment choice is a shoulder prosthesis called a hemiarthroplasty. Hemiarthroplasty has been associated to less pain and more quality of life , (2,3) but no difference in range of motion is reported when compared to non-surgically treatment of complex humeral fractures. (2,3,4) One of the important steps in surgery of a fractured humerus is the fixation of the bone fragments in an anatomically correct position as previous studies have shown that complications related to the fixation and healing of bone fragments occurred in 11 % of patients treated with a hemiarthroplasty . The Global Unite hemiarthroplasty introduces a new feature, which allows the surgeon to more closely attach the bone fragments. Patients with osteoarthritis and fractures of the humerus will be included from two hospitals, Herlev and Køge University Hospital. A total of 88 patients, 44 osteoarthritis and 44 fracture patients, are included. The patients will be followed two years after surgery and will be seen a total of four times postoperatively, where the function of the shoulder will be examined by questionnaires concerning shoulder function and quality of life, by a motion examination and by x-ray. The outcome of these examinations will be compared to the functional outcome of patients that have received different shoulder prostheses for the same diagnoses at Herlev and Køge University Hospital. The patients will undergo two radiographic scans after surgery, to determine whether or not bone fragments remain in an anatomically correct position in the patients with a fracture of the proximal humerus. A special focus will be on the function of the shoulder in patients with bone fragments that are not in an anatomically correct position. Furthermore, complications and the need of reoperation were registered during the two-year follow-up period. The aims of this study is to - Determine the function of the shoulder in patients receiving the Global Unite prosthesis due to either osteoarthritis or fracture of the humerus. - To compare these results with results from patients previously treated with a different prosthesis designs - To determine the influence of the fixation of bone fragments in the postoperative function in fracture patients.

NCT ID: NCT02944058 Active, not recruiting - Shoulder Fractures Clinical Trials

Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures

Start date: October 2016
Phase: N/A
Study type: Interventional

The purpose of the project is to compare the management of 3 and 4 part proximal humerus fractures (PHF) with an angular stable plate (Philos) with that of an intramedullary nail (Multiloc) in light of complications, radiological, economical, functional and clinical outcome.

NCT ID: NCT02524314 Active, not recruiting - Clinical trials for Acute Humerus Fractures

Safety and Efficacy Study of the Treatment of Humerus Fractures - Germany

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

The purpose of this study is to collect safety and performance data on the use of the Photodynamic Bone Stabilization System (PBSS) when used to provide stabilization and alignment for the treatment of acute humerus fractures.

NCT ID: NCT02394080 Active, not recruiting - Clinical trials for Acute Humerus Fractures

Safety and Efficacy Study of the Treatment of Humerus Fractures

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

The purpose of this study is to collect safety and performance data on the use of the Photodynamic Bone Stabilization System (PBSS) when used to provide stabilization and alignment for the treatment of acute humerus fractures.

NCT ID: NCT01480440 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System

Start date: January 2011
Phase:
Study type: Observational

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.

NCT ID: NCT00999193 Active, not recruiting - Humeral Fracture Clinical Trials

Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial

Start date: November 2010
Phase: N/A
Study type: Interventional

Fractures of the proximal humerus are common in elderly patients. The optimal treatment of comminuted, displaced fractures is subject to controversy, and the results of operative treatment have not been shown to be superior to conservative treatment. The aim of the study is to compare locking plate osteosynthesis versus treatment with fracture hemiarthroplasty versus conservative treatment in a randomised, controlled protocol. The results of treatment are measured at 6 weeks, 3 months, 6 months, 12 months and 24 months. Main outcome measures are Pain at rest and activity (NRSs) and functional assessment of the shoulder with Constant Score. Secondary outcome measures are Simple Shoulder test (SST), Disabilities of the Arm, Shoulder and Hand (DASH), quality of life assessment (15D), subjective patient satisfaction and costs. The study also has a cohort follow-up of the patiens who decline randomisation. The recruitment target was 90 patients, but the study recruitment was stopped due to slow recruitment (too few patients presenting with eligibile injury to the hospital) at 60 patients in November 2019.