ACTRN12613000781741招募中未知
Clinical Follow-up of ASR patients Post -RecallA 5 year Post Recall Clinical Follow-up study to collect longitudinal data from patients previously treated with the DePuy Articular Surface Replacement Hip System
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 5,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- All
入选标准
- •1.Any patient with on-label use of the ASR-XL or ASR component system currently implanted. Manual addition of antibiotics to cement during arthroplasty is not considered to be off-label use.
- •2.Able to provide informed consent at those sites where this is required by the institution’s institutional review (IRB) or ethics committee (EC).
- •3.Able to return for follow-up annually for 5 years.
- •4.Able to complete the required patient reported outcome measures.
排除标准
- •1.Any patient with off-label use indications for the ASR-XL or ASR component system.
- •2.Any patient who received the ASR-XL implant as a result of a hip resurfacing conversion or a revision THA.
- •3.Patients with difficulty in comprehending the Informed Consent Form for any reason.
- •4.The patient refuses to allow their medical records to be inspected by the Sponsor, representatives of the Sponsor, or the medical office staff.
研究者
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