NCT02263209进行中（未招募）不适用
Prospective Clinical Investigation to Determine the Safety of Taperloc Stems With BioGuard Coating and Exceed ABT Taperfit Acetabular Cups With BioGuard Coating When Used in Cementless Total Hip Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in normalised peri-implant BMD as measured by DXA
研究概览
简要总结
Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless total hip arthroplasty
详细描述
Bioguard Safety Study: Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless total hip arthroplasty
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for cementless primary total hip arthroplasty according to the Surgical Technique brochure (Appendix 10): "The Taperloc Porous Primary Hip and Exceed ABT Taperfit Prostheses are marketed for non-cemented use in skeletally mature patients undergoing primary hip replacement surgery of non inflammatory degenerative joint disease."
- •Under 80 and over 40 years of age
- •A pre-operative level of pain and function the same as for conventional joint replacement.
- •A likelihood of obtaining relief of pain and improved function
- •Full skeletal maturity
- •Ability to follow instructions
- •Good general health for age
- •Willing to return for follow-up evaluations
排除标准
- •Patients aged over 80 and under 40 years
- •Known allergy to any antibiotics
- •Active infection
- •Revision arthroplasty
- •Marked bone loss which could preclude or compromise adequate fixation of the device
- •Uncooperative subjects
- •Parkinson's Disease
- •Vascular insufficiency of the affected limb, which could compromise bony ingrowth/implant fixation, i.e., diabetes.
- •Severe instability or deformity of the ligaments and/or surrounding soft tissue which may preclude stability of the device
- •Pregnancy
- •BMI > 40
- •Use of immunosuppressive drugs
- •Women of child bearing potential
结局指标
主要结局
Change in normalised peri-implant BMD as measured by DXA
时间窗: 6 months post operative
次要结局
未报告次要终点
研究者
研究点 (1)
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