Functional Outcome and Complications After Global Unite ® Prostheses

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 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.

Conditions

• Osteoarthritis of the Shoulder
• Proximal Humeral Fracture

Interventions

PROCEDURE

Global Unite hemiarthroplasty

A hemiarthroplasty used for complex fractures of the proximal humerus.

PROCEDURE

Global Advantage

A total shoulder prosthesis used for osteoarthritis

PROCEDURE

Global FX

A hemiarthroplasty used for complex fractures of the proximal humerus.

PROCEDURE

Global Unite total shoulder arthroplasty

A total shoulder prosthesis used for osteoarthritis

Sponsors & Collaborators

• Zealand University Hospital

  collaborator OTHER

• DePuy Synthes

  collaborator INDUSTRY

• Herlev and Gentofte Hospital

  lead OTHER

Principal Investigators

• Alexander Amundsen, MD · University of Copenhagen

Eligibility

Min Age

50 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-01

Primary Completion

2021-01-01

Completion

2022-01-01

Countries

• Denmark

Study Locations