Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Bone Mineral Density
研究概览
简要总结
The primary purpose of this study is to measure the postoperative changes in bone mineral density, comparing the Taperloc Complete Reduced Distal Microplasty stem and the standard length Taperloc Complete Reduced Distal stem.
详细描述
The Taperloc Microplasty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption. The primary aim of this study is therefore to compare the postoperative changes in bone density with the Taperloc Microplasty stem, using the standard length Taperloc stem as a control.
In addition, the Taperloc stem has historically had a neck angle of 138°. There have been criticisms that this neck angle is too high for the typical Korean population. The newer Taperloc Complete system (both Microplasty and standard length) has a neck angle of 133°. A secondary aim is Occurrence ratio of thigh pain difference between Microplasty and standard stem in Korean Population
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suitable for primary Total Hip Replacement
- •Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of:
- •Osteoarthritis
- •Avascular necrosis
- •Legg Perthes
- •Rheumatoid Arthritis
- •Diastrophic variant
- •Sequelae of Slipped capital epiphysis
- •Traumatic arthritis
- •Patients aged over 20
- •Patients must be able to understand instructions and be willing to return for follow-up
排除标准
- •Absolute contraindications include: infection, sepsis, and osteomyelitis.
- •Relative contraindications include:
- •uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- •Small Femoral canal
- •Severe osteoporosis (Patients over 65 years old) 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and 7) vascular insufficiency, muscular atrophy, or neuromuscular disease. 8) pregnancy 9) Fracture of the pelvis 10) Subcapital fractures
研究组 & 干预措施
Taperloc Complete Standard
Group one will receive a total hip replacement with Taperloc Complete Standard. Taperloc Complete Standard is designed after the philosophy of a flat tapered wedge. It has evolved to incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, and facilitate multiple surgical techniques.
干预措施: Taperloc Complete Standard (Device)
Taperloc Complete Microplasty
Group one will receive a total hip replacement with Taperloc Complete Microplasty.Taperloc Complete Microplsty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption.
干预措施: Taperloc Complete Microplasty (Device)
结局指标
主要结局
Bone Mineral Density
时间窗: 1 year
evaluate bone mineral density around the implant
次要结局
- Radiographic Evaluation,(2 years)
- Radiographic Evaluation(6 Weeks)
- VAS Score(6 Months)
- Bone Mineral Density(Immediate post-op(2 - 4Weeks))
- Modified Harris Hip Score(6 Months)
- VAS Score(2 years)
- Modified Harris Hip Score(2 years)
- Radiographic Evaluation(1 year)
- VAS Score(1 year)
- VAS Score(6 Weeks)
- Modified Harris Hip Score(1 year)