Modern Surfaces of the Uncemented Cup in Total Hip Arthroplasty: A Randomized, Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups Using CT-based Micromotion Analysis and Clinical Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Early migration of the cup
研究概览
简要总结
A randomised controlled study comparing two types of ultra-porous coated uncemented cups in total hip arthroplasty. Primary objective is to investigate if the clinical, radiological and patient-reported outcome of the new MobileLINK TabecuLINK cup combined with an X-LINKed insert is non-inferior to the clinical and radiological outcome of the Pinnacle Gription series 100 cup combined with the Marathon liner. Patients are evaluated up to 15 years postoperatively.
详细描述
The purpose of this study is to evaluate the clinical outcome and long-term risk of development of osteolysis of a newly introduced cementless press-fit acetabular cup, consisting of a shell with a 3D surface structure and a highly cross-linked liner by precise measurement of early migration and wear.
Migration describes the movement between the implant and the surrounding bone over time. Early migration of the implant, within 2 years after operation, has shown to be a strong predictor for increased risk for late failure. Thus, high precision migration studies can be used to evaluate the performance of new implants in small groups of patients with a relatively short observation time. Wear particles are one of the main causes of periprosthetic osteolysis. Although modern, more wear resistant materials, appears to have a greatly reduced risk of osteolysis, the desired complete elimination of osteolysis appears to be yet unachieved. It is most likely that the mechanism of periprosthetic osteolysis is multifactorial.
In this study the investigators plan to include 70 patients that are planned for operation with an uncemented total hip arthroplasty. 35 patients will be randomized to receive the new implant and 35 patients will be included in the control group and receive a standard uncemented prosthesis. All patients will then be followed with CT scans and patient reported outcome measures 3-month, 1 year, 2 years, 5 years and 15 years after the operations. The CT scans will be used both for measurement of migration and wear and development of osteolysis around 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
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are foreseen for implantation of an uncemented acetabular press-fit cup and an uncemented stem
- •Age 30-70 years
- •Primary osteoarthritis of the hip
- •Body Mass Index between 18 and 35 kg/m2
- •Willingness and ability to follow clinical investigation protocol
排除标准
- •Grossly abnormal hip anatomy (hip dysplasia, Crowe Grade 2 or above, Perthes or other causes)
- •Osteoporosis
- •Paget's disease
- •Inflammatory arthritis
- •Secondary osteoarthritis
- •Presence of malignancy in the area of surgery
- •Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months or less prior to surgery
- •Previous surgery in the affected hip
- •Inclusion of the contralateral hip in this clinical investigation
- •Not suited for the clinical investigation for other reason (surgeon's judgment)
- •Pregnant or breastfeeding women
- •Prison inmate
研究组 & 干预措施
MobilLINK TrabecuLINK cup
The investigational device in this study is the newly developed MobilLINK TrabecuLINK cup. It will in this study be combined with a uncemented LCU stem.
The MobilLINK TrabecuLINK cups are made from Tilastan, a Ti6A4V alloy. The MobileLINK press-fit shells are hemispheric and polar flattened. An equatorial press-fit is built into the shells for primary stability after cementless implantation. All shells have a polar hole, which is used to connect an impactor handle for implantation of the shell. This polar hole can be closed with a polar screw. The MobileLINK TrabecuLINK shells have a 3D printed trabecular surface structure with a pore size of 610 to 820 μm and a porosity of 70 %.
干预措施: MobilLINK TrabecuLINK cup (Device)
Pinnacle Gription Series 100 cup
For the control group a Pinnacle Gription cup series 100 with a apex hole eliminator will be used together with a neutral cross-linked polyethylene (XLPE) Marathon liner (DePuy Synthes by Johnson & Johnson, Norderstedt, Germany). The Pinnacle Gription cup is a hemispherical, single-geometry, titanium press-fit cup with a solid body. The outer surface consists of a porous coating with 300 μm sintered titanium beads coated with an extra layer of irregularly shaped pure titanium pieces. In cases where no initial stability can be reached when using the Pinnacle 100 series, the Pinnacle Gription sector cup with additional bone screws will be used. The cross-linked Marathon insert is made of 1050 GUR resin, irradiated with 50 kGy, remelted and plasma sterilized.
The Pinnacle Gription cup will be implanted together with a Corail stem (DePuy Synthes).
干预措施: Pinnacle Gription cup (Device)
结局指标
主要结局
Early migration of the cup
时间窗: 2 years after operation
Migration of the cup between 3 month and 2 years after implantation of the cup measured with Computed Tomography scan based Micromotion Analysis (CTMA) in mm.
次要结局
- Proximal wear(5 years after operation)
- Long term wear(15 years after operation)
- Patient reported outcome with Forgotten Joint Score(15 years after operation)
- Reoperations(15 years after operation)
- Osteolysis(15 years after operation)
- 3D wear(5 years after operation)
- Stem migration(15 years)
- Precision of migration measurements with CTMA(1 year after operation)
- Long term migratio(15 years after operation)
- Patient reported outcome with Hip dysfunction and Osteoarthritis Outcome Score(15 years after operation)
- Patient reported outcome with University of California, Los Angeles Activity Score(15 years after operation)
- Patient reported outcome with EuroQuol 5.(15 years after operation)
- Precision of wear mearurements with CTMA(1 year after operation)