A Prospective Multi-center Randomized Study on Total Hip Replacement With E1
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 153
- 试验地点
- 5
- 主要终点
- Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period
研究概览
简要总结
The primary objectives of this clinical study include:
- Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who received Total Hip Arthroplasty with E1
- Compare E1 wear used with CoCr and Biolox Delta heads
详细描述
This study is designed as PROSPECTIVE, RANDOMIZED, MULTI-CENTER Study to compare two different materials (CoCr and Delta ceramic) articulating against E1 Highly Crosslinked polyethylene in Hip Replacement.
Patient population is 160 (80 each). Follow-up period is 10 year postoperatively. E1 liners with thickness of 4.8mm at 45 degrees position (load bearing direction) will be used in all cases.
Randomization will occur via random number generator by 4 blocks randomization.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis
- •Age between 20 - 75 at the time of operation
- •Patients with limited co-morbidity -ASA I-III
- •Patients must be able to understand instructions and be willing to return for follow up
排除标准
- •In accordance with approved Absolute and Relative Contraindications for use in participating countries for E1 liner and Delta Ceramic and CoCr femoral head hip system System.
- •Absolute contraindications include: infection, sepsis, and osteomyelitis.
- •Relative contraindications include:
- •uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- •osteoporosis,
- •metabolic disorders which may impair bone formation,
- •osteomalacia,
- •distant foci of infections which may spread to the implant site,
- •rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
- •vascular insufficiency, muscular atrophy, or neuromuscular disease.
研究组 & 干预措施
BIOLOX delta head
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
干预措施: Femoral Stem (Device)
BIOLOX delta head
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
干预措施: Acetabular Cup (Device)
BIOLOX delta head
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
干预措施: Acetabular Liner (Device)
CoCr head
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
干预措施: Femoral Stem (Device)
CoCr head
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
干预措施: Acetabular Cup (Device)
CoCr head
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
干预措施: Acetabular Liner (Device)
结局指标
主要结局
Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period
时间窗: Immediate postoperative and 2 year postoperatively
Vector wear, which is defined as movement (difference of femoral prosthetic head positions) between immediate postoperative and 2 years postoperative periods. There is no lower and upper limit, actual measured results. The outcome can be negative value.
次要结局
- WOMAC Osteoarthritis Index at 6 Month Follow-up Visit(6 month postoperative)
- WOMAC Osteoarthritis Index at 1 Year Follow-up Visit(1 year postoperative)
- Harris Hip Score at 1 Year Follow-up Visit(1 year postoperative)
- UCLA Activity Score at 6 Month Follow-up Visit(6 month postoperative)
- UCLA Activity Score at 1 Year Follow-up Visit(1 year postoperative)
- Harris Hip Score at 2 Year Follow-up Visit(2 year postoperative)
- Harris Hip Score at 3 Year Follow-up Visit(3 year postoperative)
- Harris Hip Score at 6 Month Follow-up Visit(6 month postoperative)
- WOMAC Osteoarthritis Index at 3 Year Follow-up Visit(3 year postoperative)
- UCLA Activity Score at 3 Year Follow-up Visit(3 year postoperative)
- WOMAC Osteoarthritis Index at 2 Year Follow-up Visit(2 year postoperative)
- UCLA Activity Score at 2 Year Follow-up Visit(2 year postoperative)