A Market Surveillance Study Assessing the Effect of an Alumina Free Device Surface on Bone Mineral Density in Patients Implanted With an SL-PLUS™ Femoral Stem for Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Baseline Bone mineral density by DEXA
研究概览
简要总结
Alumina particles from the grit blasting of Ti-alloy stems for hip arthroplasty are suspected to contribute to aseptic loosening. An alumina-reduced stem surface was hypothesized to improve osseointegration and show comparable short-term outcomes to those of a standard 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older undergoing primary THA for primary or secondary osteoarthritis will be enrolled.
排除标准
- •Exclusion criteria were ongoing therapy with cortisone or medications influencing bone metabolism.
结局指标
主要结局
Baseline Bone mineral density by DEXA
时间窗: Measurements will be performed 7 days (baseline) after surgery
Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).
Change from baseline Bone mineral density by DEXA at 3 months
时间窗: Measurements will be performed 3 months postoperatively
Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).
Change from baseline Bone mineral density by DEXA at 6 months
时间窗: Measurements will be performed 6 months postoperatively
Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).
Change from baseline Bone mineral density by DEXA at 12 months
时间窗: Measurements will be performed 12 months postoperatively
Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).
Change from baseline Bone mineral density by DEXA at 24 months
时间窗: Measurements will be performed 24 months postoperatively
Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).
次要结局
- Rate of radiolucent lines on hip radiographs (AP and axial) at 12 months(Measurements will be performed at 12 months postoperatively.)
- Rate of radiolucent lines on hip radiographs (AP and axial) at 24 months(Measurements will be performed at 24 months postoperatively.)
- Rate of osteolysis on hip radiographs (AP and axial) at 12 months(Measurements will be performed at 12 months postoperatively.)
- Rate of osteolysis on hip radiographs (AP and axial) at 24 months(Measurements will be performed at 24 months postoperatively.)
- Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 12 months(Measurements will be performed at 12 months postoperatively.)
- Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 24 months.(Measurements will be performed at 24 months postoperatively.)
- Baseline WOMAC(Measurements will be performed 1 month preoperatively.)
- Change in WOMAC at 12 months(Measurements will be performed 12 months postoperatively)
- Change in WOMAC at 24 months(Measurements will be performed 24 months postoperatively)
- Baseline HHS(Measurements will be performed 1 month preoperatively.)
- Change in HHS at 12 months(Measurements will be performed 12 months postoperatively)
- Change in HHS at 24 months(Measurements will be performed 24 months postoperatively)
- Survival rates(Up to 24 months postoperatively.)
研究者
Prof. Dr. med. Niklaus F. Friederich
MD, Prof.
Kantonsspital Baselland Bruderholz