THE ATX REGISTRY ATX Register Accolade Stem & Trident/Tritanium Cup With X3 Insert International Multicentre Surveillance Register
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 472
- 试验地点
- 8
- 主要终点
- Survivorship of the Device
研究概览
简要总结
The aim of this register is to determine the Accolade/Accolade II stem and Trident/Tritanium cup survivorship over years.
详细描述
This is a prospective international multicentre surveillance register. The aim of this register is to determine the Accolade/Accolade II stem and Trident/Tritanium cup survivorship over years. All institutions willing to participate to the register, able to recruit at least 20 patients (up to 100 patients)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and non-pregnant female patients between 18-75 years of age.
- •Patients requiring uncemented primary Total Hip Arthroplasty (THA), suitable for the use of the Accolade stem and Trident/Tritanium cup.
- •Patients with a diagnosis of osteoarthritis (OA).
- •Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation.
- •Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.
排除标准
- •Patients who require revision of a previously implanted hip prosthesis.
- •Patients who had a THA on contralateral side within the last 6 months.
- •Patients who had a THA on contralateral side more than 6 months ago and the rehabilitation period outcome was considered unsatisfactory or not good (Harris Hip Score < 85).
- •Patients who will need lower limb joint replacement for another joint within one year.
- •Patients requiring bilateral hip replacement.
- •Patients who have had a prior procedure of acetabular osteotomy.
- •Patients with acute femoral fractures
- •Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI ≥ 35).
- •Patients with active or suspected infection.
- •Patients with malignancy - active malignancy.
- •Patients with severe osteoporosis, rheumatoid arthritis (RA), Paget's disease or renal osteodystrophy.
- •Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
- •The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.
- •Female patients planning a pregnancy during the course of the study.
- •Patients with systemic or metabolic disorders leading to progressive bone deterioration.
- •Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
- •Patients with other severe concurrent joint involvements, which can affect their outcome.
- •Patients with other concurrent illnesses, which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis.
- •Patient with a known sensitivity to device materials.
- •Patients under the protection of law (e.g. guardianship).
研究组 & 干预措施
Accolade II stem
All patients in a participating centre matching all of the inclusion criteria and none of the exclusion criteria and who receive the Accolade or Accolade II stem and Trident/Tritanium cup with X3 liner.
干预措施: Accolade II stem (Device)
Accolade II stem
All patients in a participating centre matching all of the inclusion criteria and none of the exclusion criteria and who receive the Accolade or Accolade II stem and Trident/Tritanium cup with X3 liner.
干预措施: Trident/Tritanium cup (Device)
Accolade stem
All patients in a participating centre matching all of the inclusion criteria and none of the exclusion criteria and who receive the Accolade or Accolade II stem and Trident/Tritanium cup with X3 liner.
干预措施: Accolade stem (Device)
Accolade stem
All patients in a participating centre matching all of the inclusion criteria and none of the exclusion criteria and who receive the Accolade or Accolade II stem and Trident/Tritanium cup with X3 liner.
干预措施: Trident/Tritanium cup (Device)
结局指标
主要结局
Survivorship of the Device
时间窗: 10 years Follow-up
Survivorship shown in Kaplan Meier survival curves (statistic used to estimate the survival function from lifetime data).
次要结局
- Investigation of Clinical Performance and Patient Outcome With Modified Harris Hip Score (HHS) Patient Questionnaire(pre-operative, 1, 3, 5, 7 and 10 years follow-up)
- Investigation of Clinical Performance and Patient Outcome With Oxford Hip Score Patient Questionnaire(pre-operative, 1, 3, 5, 7 and 10 years follow-up)
- Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire(pre-operative, 1, 3, 5, 7 and 10 years follow-up)