Monocentric Randomised Controlled Trial Comparing Dual-mobility Cups Versus Unipolar Cups for Unselected Primary Total Hip Arthroplasty by Direct Anterior Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Forgotten Joint Score between DM cup group and UP cup group
研究概览
简要总结
THA comprises the replacement of the damaged bone and cartilage with prosthetic components. The proximal end of the femur is replaced with a stem and ball/head, while the acetabulum is most commonly replaced with a unipolar cup (UP) that consists of a liner inside of a metal shell. UP cups are associated with risks of dislocations, especially in elderly and female patients, as well as in patients with lumbar stiffness or operated for femoral neck fractures. In fact, one of the most common reasons for early revision of UP cups are dislocations.
Dual-mobility (DM) cups were introduced in the 1970s by the French surgeon Gilles Bousquet, as an alternative to UP cups. They are made up of two articulations, a femoral head moving inside a mobile polyethylene liner, which in turn moves inside a metal shell. This design allows for a greater jump distance and range of motion (ROM) compared to UP cups, thus resulting in reduced rates of dislocation.
A recent systematic review that evaluated 5 case-control studies (549 DM cups vs 649 UP cups) and 3 registry studies (5935 DM cups vs 217362 UP) found that in case-control studies, the dislocation rates were 0.2% for DM cups versus 7.1% for UP cups (p=0.009). Furthermore, in registry studies the revision rates due to dislocation were 0.2% for DM cups versus 0.5% for UP cups (p=0.050).
Nonetheless, there have been some concerns associated with the use of DM cups, including intra-prosthetic dislocations (IPD), polyethylene wear, and iliopsoas impingement. Since the early 2000s, new improvements in the design of DM cups have nearly eliminated the risk of IPD, and the use of ultra-high molecular weight polyethylene (UHMWPE) has greatly reduced wear rates, even in young and active patients. Lastly, although some studies have reported iliopsoas impingement with DM cups, the impingement is usually against the optional fixations, and not against the mobile polyethylene insert.
The hypothesis of the present interventional randomised controlled trial (RCT) is that THA using DM cups will not provide inferior outcomes compared to THA using UP cups, in terms of hip awareness measured using the forgotten joint score (FJS).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women aged ≥18 years old
- •set to undergo elective primary THA via direct anterior approach (DAA)
- •affiliated with a social security scheme
- •able to answer questionnaires and to communicate freely in French
- •who have been informed and have provided free, informed, and written consent (no later than the day of inclusion and before any examination required by the study)
排除标准
- •with prior ipsilateral hip surgery
- •with prior contralateral hip surgery
- •that require acetabular cup diameters ≤50mm (because DM cups are not available from the same manufacturer for diameters ≤50mm, and UP cups require head diameters of 36mm and thus minimum cup diameters of 52mm)
- •undergoing emergency or trauma surgery (e.g. femoral neck fractures)
- •with any concomitant disease or disorder which, in the opinion of the surgeon, may put the patient at risk, notably of hip instability or dislocation (hip dysplasia, neuromuscular deficit, fracture sequelae…) or may influence the result of the study
- •that are pregnant or breastfeeding
- •under legal protection (guardianship or curatorship or deprived of liberty).
研究组 & 干预措施
THA with unipolar cup
The THA will be performed via the DAA. The liner will be made of highly-crosslinked vitamin-E infused polyethylene. The femoral head will be made of either metal or ceramic. The unipolar cup will always be cementless, while the stem will be cemented in female patients aged ≥75 years, as well as in any patient diagnosed with osteoporosis. A blunt dissection will be carried out through the tensor fasciae latae muscle (TFLM), between the sartorius and rectus femoris muscles. A femoral neck osteotomy will then be performed using an oscillating saw, and the femoral head will be removed with a corkscrew. The acetabular components and the selected liner according to the randomisation, will then be implanted.The femoral head will then be impacted onto the femoral stem, and the prosthesis will be reduced. Closure of the surgical site will be performed in layers.
干预措施: Primary total hip arthroplasty using unipolar cup (Procedure)
THA with dual-mobility cup
The THA will be performed via the DAA. The liner will be made of highly-crosslinked vitamin-E infused polyethylene. The femoral head will be made of either metal or ceramic. The dual-mobility cup will always be cementless, while the stem will be cemented in female patients aged ≥75 years, as well as in any patient diagnosed with osteoporosis. A blunt dissection will be carried out through the tensor fasciae latae muscle (TFLM), between the sartorius and rectus femoris muscles. A femoral neck osteotomy will then be performed using an oscillating saw, and the femoral head will be removed with a corkscrew. The acetabular components and the selected liner according to the randomisation, will then be implanted.The femoral head will then be impacted onto the femoral stem, and the prosthesis will be reduced. Closure of the surgical site will be performed in layers.
干预措施: Primary total hip arthroplasty using dual-mobility cup (Procedure)
结局指标
主要结局
Forgotten Joint Score between DM cup group and UP cup group
时间窗: 2 years
The primary outcome is defined as patient-reported hip awareness at 2 years postoperatively, measured using the Forgotten Joint Score (FJS). The FJS is a validated self-administered questionnaire that measures the patients' ability to forget about a joint as a result of successful treatment. The questionnaire comprises 12 items. Each item is scored using a 5-point Likert scale, ranging from "never" (0 points) to "mostly" (4 points). The final FJS score is calculated as the addition of all items, divided by the number of items answered. The mean score is then multiplied by 25, and that value is subtracted from 100. The FJS ranges from 0 to 100, with 100 corresponding to the best score: the patient has forgotten about their joint.
次要结局
- Forgotten Joint Score between DM cup group and UP cup group(3 months and 1 year)
- To compare the patient's hip/groin pain between DM cups versus UP cups, as well as to compare the net change from baseline(preoperatively, at 3 months, 1 year and 2 years)
- To compare the patient's hip function between DM cups versus UP cups(preoperatively, at 3 months, 1 year and 2 years)
- To compare the patient's sports activity between DM cups versus UP cups(1 year)
- To compare the patient's sports activity between DM cups versus UP cups(preoperatively, at 1 year and 2 years)
- To compare the patient's sexual activity between DM cups versus UP cups(1 year)
- To compare the patient's satisfaction with surgery between DM cups versus UP cups(1 year)
- To compare adverse events (that may impact the objectives of the study) between DM cups versus UP cups(intraoperatively, at 3 months, 1 year and 2 years)