An Open-label, Prospective, Post-market, Historically Controlled, Multi-center Clinical Evaluation of the Trident® X3 Polyethylene Acetabular Inserts.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 9
- 主要终点
- Rate of Incidence of Revision of Component for Any Reason
研究概览
简要总结
The primary objective of the study is to demonstrate the linear wear rates of the Trident® X3 polyethylene insert are superior to a polyethylene control group wear rate at 5 years postoperative. This measurement will be evaluated by comparing digitized images of serial radiographs obtained over a follow-up period of 5-years.
详细描述
The study is a prospective, multi-center, historical-controlled clinical evaluation of the Trident® X3 Polyethylene insert. The device is commercially available in the United States where the study is being conducted. The study device, the Stryker Orthopaedics Trident® X3 polyethylene insert, is used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices. The control device, the Stryker Orthopaedics N2VAC polyethylene insert, is also used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has signed an IRB-approved, study specific Patient Informed Consent Form.
- •The patient is a candidate for a primary total hip replacement with cementless acetabular and femoral components.
- •The patient has a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). Patient must have diagnosis of osteoarthritis (OA), traumatic arthritis (TA), avascular necrosis (AVN), slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant.
- •The patient is a male or non-pregnant female patient ages 21 to
- •The patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
排除标准
- •The patient has an active infection with the affected hip joint.
- •The patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
- •The patient has a BMI >
- •The patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- •The patient has diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
- •The patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
- •The patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
- •The patient is a prisoner.
研究组 & 干预措施
Trident® X3 Polyethylene Insert
Participants who received the Trident® X3 Polyethylene Insert.
干预措施: Trident® X3 Polyethylene Insert (Device)
结局指标
主要结局
Rate of Incidence of Revision of Component for Any Reason
时间窗: 5 year
Revision of any component is defined as surgical removal and replacement of the femoral component, acetabular shell, acetabular insert and/or femoral head.
Mean Linear Wear Rate at 5 Years
时间窗: 5 years
Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period of 5 years
次要结局
- Radiographic Stability(1,2,3,4 and 5 years)
- Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change(pre-operative, 1,3 and 5 years)
- Volumetric Wear Rate of the Trident X3 Polyethylene Insert(2, 3, 4 and 5 year films collected; 3, 4 and 5 year wear assessed)
- Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change(pre-operative, 1,3 and 5 years)
- Mean SF-12 Health Survey Score to Assess Change(pre-operative, 1,3 and 5 years)
- Linear Wear Rate of the Trident X3 Polyethylene Insert(2, 3 and 4 year films collected; 3 and 4 year wear assessed)
- Mean Harris Hip Score (HHS) to Assess Change(pre-operative, 1,3 and 5 years)
- Mean Harris Hip Score (HHS) Pain Score to Assess Change(pre-operative, 1,3, and 5 years)
- Implant Survivorship(10 years)