RCT of the Sirius Stem Used in Conjunction With the Exceed ABT Cemented Cup and OptiPac/OptiVac Cement - Model Based RSA, Clinical and Radiographic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Radiostereometry (RSA) - change in migration and wear over time
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of the Sirius Cemented Stem used in conjunction with the Exceed ABT Cemented Acetabular Cup, either with E1 or Arcom polyethylene, and OptiPac/OptiVac bone cement mixing systems.
详细描述
This is a comparative, prospective randomized Radiostereometry (RSA) study, lead on 48 patients in a single site.
All 48 patients will be pooled in a single group for the evaluation of the primary criterion for evaluation, but randomized into four groups for the evaluation of the secondary criteria for evaluation
The objectives of the study are to:
- Demonstrate a comparable migration pattern as is described in published literature on other double tapered polished cemented stems
- Measure wear pattern in the cup made of vitamin-E doped polyethylene or conventional Arcom polyethylene
2)Demonstrate non-inferiority of Optipac vs. Optivac cement mixing systems on the stem side 3)Evaluate the clinical outcome and survivorship of the implant
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are eligible for cemented total hip arthroplasty
- •Patients diagnosed with primary Osteoarthritis
- •Patients who are fit for elective surgery (ASA I - III)
- •Patients with a BMI between 16 and 40
- •Patients who are skeletally mature
- •Patients aged over 18 at the time of surgery
- •Patients willing to return for follow-up evaluations
- •Patients who have the ability to follow instructions
- •Patients with sufficient bone stock and quality
排除标准
- •Female patients who are pregnant or planning pregnancy during the course of the study (no use of adequate birth control)
- •Patients with diagnosed active infection
- •Patients with marked bone loss which could preclude or compromise adequate fixation of the device
- •Patients with Parkinson disease
- •Patients using immunosuppressive drugs
- •Patients with an immunosuppressive disease
- •Patients with BMI <16
- •Patient with BMI >40
- •Patients who are unfit for surgery (ASA IV - V)
- •Patients with acetabular or femoral osteotomy
- •Patients who had a THA on the contralateral side within last 6 months
- •Patients belonging to the vulnerable population: children, patients with mental
结局指标
主要结局
Radiostereometry (RSA) - change in migration and wear over time
时间窗: First postoperative day, 3 months, 1 year, 2 years and 5 years
Prosthesis migration and cup wear are measured over time, from baseline directly postop up to 5years. Measures are given in change in mm (translation) and degrees (rotation) around x, y and z-axis.
次要结局
- EQ5D(Preoperatively, 1 year, 2 years and 5 years)
- Conventional Radiography (Signs of radiolucent lines or obvious change of position will be measured in mm)(First postoperative day, 2 years and 5 years)
- HOOS (Hip specific health questionnaire)(Preoperatively, 1 year, 2 years and 5 years)