Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Functional Outcome and Complications After Global Unite ® Prostheses in Osteoarthritis and Displaced Fractures of the Proximal Humerus.
Brief Summary:
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