Corail-SP Study - A Prospective Randomized Comparison Between Cemented and Uncemented Hydroxyapatite Coated Prosthesis Stems in Total Hip Arthroplasty in Patients With Femoral Neck Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Time to mobilization.
研究概览
简要总结
The purpose of this prospective randomized study is to compare the quality of treatment between cemented versus uncemented hydroxyapatite coated femoral stems in Total Hip Arthroplasty (THA) in patients who suffers from dislocated femoral neck fractures.
Our hypothesis is that an uncemented option spares the patient the operative load of the cementing procedure, i e risk of fatty embolism and inflammatory response, which in turn also perhaps reduces the postoperative cognition strain and improves mobilization parameters.
If the uncemented option has the same excellent fixation in poor bone stock, as in the case of these osteopenic fractures, and also has the same good clinical outcome, it would be a viable standard option for the treatment of dislocated femoral neck fractures.
详细描述
Corail-SP study. A prospective randomized study to compare the quality of treatment between cemented versus uncemented hydroxyapatite coated femoral stems in Total Hip Arthroplasty (THA) in patients who suffers from dislocated femoral neck fractures.
Femoral neck fractures often occurs among the fragile elderly patients who have a higher degree of co-morbidity. The 3-month mortality is 13%. The incidence of risk of fracture complications when using osteosyntheses are as high as 30-40%, mainly due to non union, which leads to impairments in quality of life, locomotion and pain.
For that reason more patients nowadays are submitted to a cemented hemiarthroplasty or a total hip arthroplasty directly after their injury - at the same time the problem with fatty embolism syndrome has been recognized. When cementing during surgery, the bone marrow is pushed into the blood stream, which can affect the cardiopulmonary function and even the mental functions.
As a measure for reducing those risks an uncemented hip arthroplasty is sometimes used instead.
The pros and cons with uncemented fixation is poorly examined which this study will try to scrutinize.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are acutely admitted to hospital with dislocated femoral neck fractures, that in clinical praxis are in the need of hip prosthesis surgery, are recruited in the study. The fracture shall not engage the lesser nor the greater trochanters.
- •Patients who wants to participate in the study and who can consider participation for at least 1 year.
- •Coming from independent dwelling conditions.
- •Not dementia.
- •Circa 60-85 years of age.
- •Circa 50 patients in each arm/group shall be included at Mölndal's Hospital (part of Sahlgrenska University Hospital).
排除标准
- •Patients who have difficulties in understanding the intent of the study.
- •Rheumatic disorders (RA, Bechterew, SLE).
- •Cortison treatment.
- •Stroke with remaining weakness or neurological disorders with affection of locomotion.
- •Dementia.
- •Grave obesity with BMI >=30-
- •Delay between time of injury and time of surgery exceeding 72 hours.
结局指标
主要结局
Time to mobilization.
时间窗: During hospital stay, an expected average of 10 days.
Time (days) to mobilization defined as independent walking with or without walking aids measured by ward physiotherapist with Traffic Light System and Sahlgrenska University Hospital Hip Score (SUHS).
次要结局
- Biomarkers / inflammatory response.(Preoperatively in average 4 hours. Peroperatively at end of wound closure. Postoperatively 1, 3, 5, 7 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years.)
- Fixation / migration / loosening of the hip prosthesis components.(Postoperatively in average after 2 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years.)
- Reoperation.(Postoperatively up to 10 years.)
- PROM - Patient Reported Outcome Measurements.(Preoperatively in average 4 hours. Postoperatively at discharge from hospital at an expected average of 10 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years.)
- Oxygen saturation levels peroperatively.(Peroperatively (during surgery), an expected average of 2 hours.)
- Bone remodeling around the hip prosthesis.(Postoperatively in average after 2 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years.)
- Cognitive status. Eventual confusion.(During hospital stay, an expected average of 10 days.)
研究者
Arun Patel, MD
Senior Physician in Orthopaedic Surgery
Sahlgrenska University Hospital