Clinical Trial: Functional Outcome and Complications After Global Unite ® Prostheses
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
Detailed Summary:
The study was based on data from Køge and Herlev University Hospital. All patients that fit the inclusion criteria and had an indication for shoulder replacement where included and the study started on the 1st of January 2017.
Aim
- To determine 2-year postoperative outcome, complications and revision rates in patients receiving a Global Unite
- To compare the postoperative outcome to patients from a in matched control group
- To determine the influence of tuberosity placement and migration on functional outcome in patients with a fracture of the proximal humerus.
The trauma mechanism of the fractures and health status of the patients were determined upon arrival. A preoperative CT-scan was performed in all fracture patients for preoperative planning. A CT-scan was also performed preoperatively in the osteoarthritis patients to determine the degree of bone degeneration. An x-ray was performed right after surgery, 3 months and 24 months postoperatively.
The patients included received a Global Unite hemiarthroplasty in the fracture situation and a Global Unite total shoulder in osteoarthritis patients. The patients received standardized postoperative analgesic treatment and physiotherapy rehabilitation and all patients had postoperative follow-up 3, 6 months, 1-year and 2-year after surgery. The outcome at the follow-up was determined by using Oxford Shoulder Score, Constant-Murley score, EQ-5-D questionnaire and Western Ontario Osteoarthritis of the Shoulder index
Factors like American Society of Anesthesiologists score, body-mass index, smoking, alcohol, medication and
Sponsor: Herlev and Gentofte Hospital
Current Primary Outcome:
- Functional outcome (Western Ontario Osteoarthritis of the Shoulder (WOOS)) [ Time Frame: 3 months after surgery ]The WOOS questionnaire is used to measure the patient-reported functional outcome for the patients.
- Functional outcome (Western Ontario Osteoarthritis of the Shoulder (WOOS)) [ Time Frame: 6 months after surgery ]The WOOS questionnaire is used to measure the patient-reported functional outcome for the patients.
- Functional outcome (Western Ontario Osteoarthritis of the Shoulder (WOOS)) [ Time Frame: 12 months after surgery ]The WOOS questionnaire is used to measure the patient-reported functional outcome for the patients. . The outcome will be compared with outcome of patients that previously received Global FX or Global Advantage for fracture or osteoarthritis, respectively.
- Functional outcome (Western Ontario Osteoarthritis of the Shoulder (WOOS)) [ Time Frame: 24 months after surgery ]The WOOS questionnaire is used to measure the patient-reported functional outcome for the patients. The outcome will be compared with outcome of patients that previously received Global FX or Global Advantage for fracture or osteoarthritis, respectively.
- Functional outcome (Constant-Murley Score (CMS)) [ Time Frame: 3 months after surgery ]CMS is used to measure the functional outcome for the patients.
- Functional outcome (Constant-Murley Score (CMS)) [ Time Frame: 6 mont
Original Primary Outcome: Same as current
Current Secondary Outcome: Tuberosity migration or vanishing in fracture patients [ Time Frame: Baseline CT-scan, x-rays 3 and 24 months after surgery ]
A preoperative CT-scan will be performed and postoperative x-rays will be performed to determine whether or not the tuberosities have migrated or vanished in the fracture patients treated with Global Unite hemiarthroplasty
Original Secondary Outcome: Same as current
Information By: Herlev and Gentofte Hospital
Dates:
Date Received: March 15, 2017
Date Started: January 1, 2017
Date Completion: January 1, 2022
Last Updated: March 27, 2017
Last Verified: March 2017
