Primary Uncemented Total Hip Prosthesis With Pure Ti With and Without HA, and Alumina-on-alumina Articulation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Survival with revision as endpoint.
研究概览
简要总结
Both HA coated and certain uncoated femoral stems have good results in general. On the cup side the results are more variable, either with or without HA. HA may delaminate from the prosthesis, damage the articulation, witch may lead to osteolysis and aseptic loosening.
The investigators are investigating whether a well working uncemented hip prosthesis design with HA coating, will perform without HA in the long run, when the investigators use pure Ti macrostructure and alumina on alumina articulation.
Hypothesis: The bone ingrowth will be equal when the surface has almost equal roughness in Ti and HA version. This means that HA on Ti is not necessary with a well functioning prosthesis design.
0-hypothesis:The two prosthesis perform equal in survival, clinically (HHS),radiographic and in patient satisfaction at 2, 5, 10, 15 and 20 years.
详细描述
Investigate survival of the implants and possible biological consequences. Clinical outcome with Harris Hip Score. Radiographic outcome with a modified protocol after JRC, JBJS 1990. Patient satisfaction with the hip prosthesis (five categories).
Grit blasted TiAL6V4 + pure Ti versus grit blasted TiAL6V4 + pure Ti +HA, with almost the same roughness. Screw cup, double tapered stem, partly double coated cup, proximally double coated stem.
Prospective RCT. Multicenter ( Three hospitals). Selected surgeons. Non-inferiority-design.
At present 569 hips (391 patients, 178 bilateral) are randomized into the study. Inclusion of patients into the study stopped in January 2013.
548 hips have completed follow ups at an average of 2 years, 301 hips have completed follow ups at an average of 5 years and 60 hips at 8-10 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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or secondary osteoarthrosis.
- •Both gender, less than seventy years.
- •Patients operated for FCF and patients with previous osteotomies are included.
排除标准
- •Treatment with Prednisolon.
- •Osteomyelitis.
- •Serious infections illnesses.
- •Cancer or metastasis.
- •Rheumatoid arthritis.
- •Osteonecrosis after use of alcohol or medicaments.
- •Kidney illnesses.
- •Metabolic bone diseases.
- •Earlier hip arthrodesis.
- •Allergic reactions on implants.
- •Patients who do not cooperate on rehabilitation.
研究组 & 干预措施
pure Ti
Cup and stem partly coated with pure titanium
干预措施: Uncemented primary total hip arthroplasty (Procedure)
pure Ti and HA
Cup and stem partly coated with pure titanium, and fully coated with HA.
干预措施: Uncemented primary total hip arthroplasty (Procedure)
结局指标
主要结局
Survival with revision as endpoint.
时间窗: 5-20 years
次要结局
- Clinical outcome with Harris Hip Score.(10-30 years)
- Radiographic outcome.(10-30years)
- Patient satisfaction with the hip prosthesis.(10-30 years)