Risk of Dislocation After Total Hip Replacement: Dual Mobility Cup vs. Unipolar Cup. A Randomized Controlled Trial With Patients ≥65 Years Operated for Hip Osteoarthritis With Primary Total Hip Replacement (THR).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Early dislocation, Difference in dislocation within 1 year.
研究概览
简要总结
The general purpose of this study is to examine whether the dual mobility cup (Novae® Serf) reduces the number of hip dislocations after total hip replacement, both early dislocation (≤1 year) and late dislocation (>1 year) after primary THR compared with a conventional cup design (Trabecular MetalTM Modular Acetabular System).
详细描述
Surgery with THR for arthritis and other hip disorders has long been one of the most successful orthopedic surgical treatments. The majority of the patients gain pain relief and experience improved hip function. In 2017, a total of 10,691 THRs were implanted in Denmark (annual report 2018).
Hip dislocation is a known complication after THR. It is a painful condition which may have far-reaching consequences for the patient, who may experience both physical and mental discomfort. Ultimately, multiple hip dislocations may result in reoperation.
In the literature, the incidence of hip dislocation is reported at 2-6 %, and a more recent review reports a risk of 0.5-10 %.
In Denmark, recurrent hip dislocation is the cause of 21 % of the reoperations per year according to The Danish Hip Arthroplasty Register. According to the British National Joint Registry (NJR) and the Australian register (AOANJRR), hip dislocation is the cause of 15.5 % and 21 %, respectively, of the reoperations.
The best method to avoid reoperation due to instability is to choose the correct implant for the individual patient and thereby spare the patient of having to endure a painful complication and yet another procedure. There are multiple risk factors for instability after THR, and increased use of dual mobility cups (DMC) is already documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hip arthritis who are amenable to surgery with THR and age ≥ 65 years referred to the Department of Orthopedic Surgery at either Section Farsø, Frederikshavn Hospital or Aalborg University Hospital. Patients who are willing to participate in the trial and who give their written, informed consent after receiving oral and written information.
排除标准
- •Patients who do not wish to participate.
- •Sequelae of Calvé-Legg-Perthes' disease, caput necrosis, epiphysiolysis.
- •Proximal femoral or acetabular fracture.
- •Hip dysplasia with subluxation Crowe types III and IV.
- •Earlier hip bone surgery (excluding arthroscopic surgery).
- •Elective bilateral surgery.
- •If the patient's bone morphology is unsuitable for a cemented Exeter® femoral stem.
- •Patients with no e-mail.
结局指标
主要结局
Early dislocation, Difference in dislocation within 1 year.
时间窗: 1 year after surgery
The primary outcome is the difference in cumulative incidence proportion of dislocation between the 2 randomized groups within the first year after total hip replacement. The information will be collected from both the patient through questionnaires and from the Danish Hip Arthroplasty Register and the Danish National Patient Register.
次要结局
- Difference in dislocation within 5 years(5 years after surgery)
- Patient reported outcome measure: Oxford Hip Score (OHS)(1, 5 and 10 years)
- Dislocation 10 year(10 years after surgery)
- Patient reported outcome measure: European quality of life 5 dimensions (EQ-5D 5L)(1, 5 and 10 years)
- Patient reported outcome measures: The Copenhagen Hip and Groin Outcome Score (HAGOS)(1, 5 and 10 years)
- Prosthesis survival.(1, 5 and 10 year)