Effectiveness of Dual-mobility Cups for Preventing Dislocation After Primary Total Hip Arthroplasty by a Posterolateral Approach and Their Cost-effectiveness Compared to Unipolar Cups in Elderly Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,100
- 试验地点
- 2
- 主要终点
- Number of dislocations
研究概览
简要总结
Objective: The primary objective is to investigate whether there is a difference in the number of hip dislocations following primary total hip arthroplasty (THA), using the posterolateral approach, with a DM cup compared to a unipolar cup in elderly patients 1 year after surgery.
Study design: Prospective multi-center nation wide, single blinded RCT nested in the LROI.
Study population: Patients ≥ 70 years old, undergoing an elective primary cemented THA.
详细描述
Rationale: Dislocation is the leading reason for early revision surgery. To address the problem of dislocation, the dual-mobility (DM) cup was developed in France in the 1970's. This cup should provide more stability and biomechanically reduce the risk of dislocation. In the Netherlands, most DM cups are placed in specific patients, e.g. with cognitive impairment and for revisions due to recurrent dislocations. Despite the increased and, in some countries, broad use of DM cups, high quality evidence of their (cost)effectiveness is lacking. This study aims to perform a trial to fill this gap in knowledge. Much of the information needed to judge the effectiveness of DM cups is already incorporated in the Dutch Arthroplasty Register (LROI). This register lends itself perfectly for a nested RCT towards this aim.
Objective: The primary objective is to investigate whether there is a difference in the number of hip dislocations following primary total hip arthroplasty (THA), using the posterolateral approach, with a DM cup compared to a unipolar cup in elderly patients 1 year after surgery. The secondary objectives are: to investigate whether there is a difference in the number of revisions; to investigate what the cost-effectiveness and cost-utility is of a DM cup compared to a unipolar cup at 1 year follow-up; to investigate whether there is a difference in the number of hip dislocations and revisions between a DM cup and a unipolar cup 2 years after surgery; to investigate whether there is a difference in patient reported outcomes between a DM cup compared to a unipolar cup 1 and 2 years after surgery; to compare the number of hip dislocations, revisions and PROM data between patients in the randomized DM group and patients in an observational cohort DM group. Finally, long-term survival of DM and unipolar cups will be evaluated based on revision and mortality data registered in the LROI.
Study design: Prospective multi-center nation wide, single blinded RCT nested in the LROI.
Study population: Patients ≥ 70 years old, undergoing an elective primary cemented THA.
Intervention (if applicable): The intervention group receives a THA with a dual mobility cup, the control group receives a THA with a unipolar cup.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are eligible for elective primary THA with a cemented cup, with a 32mm or 36 mm liner, for any indication.
- •THA using posterolateral surgical approach.
- •Patients ≥ 70 years old
- •Adequate comprehension of written and spoken Dutch
排除标准
- •Patients unable to complete PROMs
- •Patients with dementia, epilepsy*, spasticity*, mental retardation or alcoholism. (If dementia or mental retardation is not already mentioned in the medical chart, this can be determined by doctors opinion.)
- •Patients not eligible for either a unipolar or a DM cup
- •These patients will be asked to participate in the non-randomized dual mobility observational cohort.
结局指标
主要结局
Number of dislocations
时间窗: 1 year postoperative
The total number of dislocations, regardless of type of treatment (i.e. closed repositioning or revision).
次要结局
- Number of dislocations(2 years postoperative)
- Patient Reported Outcomes on pain(1 and 2 years postoperative)
- Patient Reported Outcomes on quality of life(1 and 2 years postoperative)
- Implant survival(5 - 10 years postoperative)
- Number of revision surgeries(1 year postoperative)
- cost-effectiveness questionnaire(1 year postoperative)
- Patient Reported Outcomes on physical functioning(1 and 2 years postoperative)