Functional Outcome and Complications After Global Unite ® Prostheses in Osteoarthritis and Displaced Fractures of the Proximal Humerus.
试验速览
- 阶段
- 不适用
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Functional outcome (Western Ontario Osteoarthritis of the Shoulder (WOOS))
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis patients:
- •Pronounced osteoarthritis
- •physician-assessed need of surgery
- •Surgery at Herlev University Hospital
- •Fracture patients:
- •Luxation fractures
- •4-part fractures
- •Displaced 3-part fractures
- •Headsplit fractures
- •Treated at Herlev University Hospital or Køge University Hospital
- •Control group:
- •Surgery from 2013-2017
- •Treated for osteoarthritis with Global Advantage
- •Osteoarthritis surgery at Herlev University Hospital
- •Treated with Global FX due to fracture of the proximal humerus
- •Global FX treatment at Herlev or Køge University Hospital
排除标准
- •Patients not living in Denmark
- •Two-part fractures of the proximal humerus
- •Patient without a Danish civil registration number
- •Patients younger than 50
- •Revision surgery
- •Previous arthroplasty procedures in the same shoulder
- •Deceased patients
结局指标
主要结局
Functional outcome (Western Ontario Osteoarthritis of the Shoulder (WOOS))
时间窗: 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))
时间窗: 24 months after surgery
CMS is used to measure the 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 (Oxford Shoulder Score (OSS))
时间窗: 24 months after surgery
The OSS questionnaire is used to measure the patient-reported functional outcome. The outcome will be compared with outcome of patients that previously received Global FX or Global Advantage for fracture or osteoarthritis, respectively
次要结局
- Tuberosity migration or vanishing in fracture patients(Baseline CT-scan, x-rays 3 and 24 months after surgery)
研究者
Alexander Amundsen
Principal investigator
Herlev and Gentofte Hospital