Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty. A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Can risedronate given once weekly for 6 months prevent periprosthetic bone loss up to 2 years after uncemented total hip arthroplasty
研究概览
简要总结
Can risedronate given once weekly for 6 months prevent periprosthetic bone loss after uncemented total hip arthroplasty?
详细描述
Periprosthetic bone loss after total hip arthroplasty is the main factor in limiting the longevity of implants used for treatment of osteoarthritis. Bone loss leads to implant destabilization. Bisphosphonates, given for approximately 6 months after THA man prevent this bone loss and lead to longer implant fixation and lower incidence of aseptic prosthesis loosening. We perform a clinical trial with risedronate to investigate if we can influence periprosthetic bone loss around a uncemented femoral stem.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on the waiting list for a total hip arthroplasty
- •Primary osteoarthritis
- •Osteoarthritis secondary to congenital dislocation of the hip
排除标准
- •Rheumatoid arthritis
- •Bisphosphonate treatment
- •Osteomalacia
- •Hypocalcemia
- •Previous surgery of the affected hip
研究组 & 干预措施
Risedronate
干预措施: Risedronate (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Can risedronate given once weekly for 6 months prevent periprosthetic bone loss up to 2 years after uncemented total hip arthroplasty
时间窗: 4 years
次要结局
- Can risedronate reduce migration of a uncemented femoral stem(4 years)
研究者
Olof Skoldenberg
Consulatant Orthopaedic Surgeon
Danderyd Hospital