A Prospective Randomised Rontgen Stereophotogrammatic Analysis (RSA) Study Using the Uncemented Trident Tritanium Acetabular Component and the Uncemented HA Coated Symax Hip Stem in a Single Centre: Assessment of Implant Migration, Bone Remodeling and Clinical Function
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- prosthetic migration of the uncemented acetabular and femoral total hip components
研究概览
简要总结
The Trident Tritanium acetabular component of a total hip prosthesis is a new developed uncemented acetabular component. In this randomized controlled trial (RCT) the tritanium cup will be compared with the Trident HA acetabular component in two equal sized groups. The Symax HA coated stem will be used as femoral component in both groups.
Study Objectives:
- The primary objective is to determine the prosthetic migration of the uncemented acetabular and femoral total hip components using model based RSA technique
- Secondary objectives are on one hand to assess clinical outcome on the other hand assessing patient satisfaction in both groups using Harris Hip Score, Oxford Hip Score, WOMAC, and EQ-5D questionnaires
- Tertiary objective is to assess bone remodeling of the uncemented acetabular components and the HA-coated Symax hip stem using QCT derived from usinf F18-fluoride PET in a cohort of 12 consecutive patients of this RCT
A total of 50 patients will be enrolled in this RCT divided into two equal groups. Patients have to fulfill the inclusion and exclusion criteria.
All evaluations will be done pre-operatively with 2 weeks before surgery, and after surgery at 4 weeks, 3 and 6 months and 1 and 2 years.
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a BMI < 35
- •Patients requiring uncemented primary THA
- •Primary diagnosis of osteoarthritis
排除标准
- •patients with acetabular or femoral osteotomy
- •Patients who had a THA on the contralateral side within last 6 months
- •Female patients who are pregnant or planning pregnancy during the course of the study
- •Patients with active or suspected infection
- •patients with malignancy
- •patients with a systemic disease that would effect the subject's welfare or overall outcome of the study
- •Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
- •Patients with systemic or metabolic disorders leading to progressive bone deterioration
- •Patients with other illnesses which are likely to affect their outcome
- •Patients with known sensitivity to device materials
研究组 & 干预措施
Tritanium cup
干预措施: Tritanium acetabular component (Device)
Trident HA cup
干预措施: Tritanium acetabular component (Device)
结局指标
主要结局
prosthetic migration of the uncemented acetabular and femoral total hip components
时间窗: 2 years
determine the prosthetic migration of the uncemented acetabular and femoral total hip components using model based RSA technique
次要结局
- clinical outcome and patient satisfaction(2 years)