Metal-metal Articulations vs Standard 28 mm Cementless Total Hip Arthroplasty in Younger Patients. Randomized Studies
试验速览
- 阶段
- 2 期
- 入组人数
- 71
- 试验地点
- 4
- 主要终点
- Range of motion
研究概览
简要总结
Younger hip patients often need revision of their hip replacement due to wear and loosening. Newer concepts (resurfacing and large head total hip replacement) with articulation surfaces in metal may reduce the wear, increase the longevity of the implant and give an improved function. The possible downside is that these concepts releases metal debris to the body. The investigators wish to see if the newer interventions are a clinical improvement compared to standard. The investigators also wish to investigate the extent of metal released to the body and any effect on the immune system. Finally the investigators wish to investigate the stability of these new implants and their ability to preserve the bone around the implant.
The investigators hypothesis is:
That the metal on metal articulations will not have better clinical outcomes than standard The resurfacing implant is expected to preserve the bone of the upper femoral bone. The implants are expected to be stabile within the first year.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary hip osteoarthritis
- •Secondary osteoarthritis due to mild dysplasia
- •Age from 40 to 65 years
排除标准
- •Dysplasia with CE angle < 25 degrees on the AP projection
- •Severe femoral head deformation
- •Reduced femoral neck length
- •Leg length discrepancy more than 1 cm
- •Need for restoration of offset
- •Deformation after fractures or earlier osteotomies
- •A previous hip arthroplasty
- •Inflammatory arthritis
- •Endocrinological disease with bone metabolic manifestations
- •Renal disease
- •Malignant disease
- •Neuro/muscular or vascular diseases of the affected leg
- •Osteoporosis
- •Use of opioid pain killers due to other diseases
- •High dose corticosteroids
- •Obese with BMI > 35
- •Pregnant or planning to be
- •Ppresented problems that would prevent completing our follow-up program
研究组 & 干预措施
28 mm ceramics-polyethylene
a standard 28 mm head uncemented THA
干预措施: Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet (Device)
28 mm metal-polyethylene THA
a standard stemmed uncemented THA
干预措施: 28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer) (Device)
resurfacing
a hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint
干预措施: articular surface replacement ASR, DePuy (Device)
large head THA
a standard stemmed THA but with a large metal head, and a metal-metal articulation
干预措施: ReCap/Magnum modular head, Biomet (Device)
结局指标
主要结局
Range of motion
时间窗: 1 year +/- 1 month
range of motion in the hip joint
range of motion
时间窗: 2 year +/- 1 month
range of motion in the hip joint
次要结局
- Metal ions(1 year +/- 1 month)
- HHS(2 years +/- 1 month)
- WOMAC(2 years +/- 1 month)
- RSA(2 year +/- 1 month)
- UCLA activity(2 years +/- 1 month)
- surgery time(during surgery)
- BMD(2 year +/- 1 month)
- metal ions(2 year +/- 1 month)
- complications(within the first 2 years following surgery)
- EQ-5d(2 years +/- 1 month)
- days in hospital(from admission to discharge from hospital)
- T cell count(2 years +/- 1 month)
- X-ray(within 2 years of surgery)
- steps(2 years +/- 1 month)
- sick leave(assesed 6 months following surgery.)
- blood loss(during surgery)
- incision length(during surgery)
研究者
jeannette ostergaard penny
MD, PhD
University of Southern Denmark