Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U-Motion II+ Acetabular System and UTF Reduced Stem
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Operative Success
研究概览
简要总结
This is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total hip arthroplasty (THA) with the U-Motion II+ Acetabular System and UTF Reduced Stem.
详细描述
This is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total hip arthroplasty (THA) with the U-Motion II+ Acetabular System and UTF Reduced Stem. The acetabular and femoral components will be uncemented. Study outcomes will be analyzed and published when 1.) all enrolled and implanted subjects complete their 6-week follow up, 2.) all implanted subjects complete their 2-year follow up, 3.) at the conclusion of the study.
It is anticipated that up to 200 subjects will be enrolled at up to 5 sites. The subjects will be evaluated at predetermined intervals: baseline, procedure/ discharge and 6 weeks, 3 months, 6 months, 12 months, and 24 months post treatment for primary analysis and annually up to 5 years for device survivorship. The estimated study duration from first enrollment through completion of the final report is expected to be approximately 7 years.
This study will be conducted at up to 5 investigational sites in the United States with previous clinical research experience and with adequate population of orthopedic patients requiring primary total hip arthroplasty.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria to be considered for inclusion in the study.
- •Subject is between 18 and 75 years of age
- •Subject is indicated for a unilateral or bilateral total hip arthroplasty (THA) based on the approved labeling of the device
- •Subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative hip
- •Subject is willing and able to provide informed consent to participate in the study;
- •Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits;
排除标准
- •Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.
结局指标
主要结局
Operative Success
时间窗: 2 Years
Post-operative increase in Harris Hip Score of \> 20 points + radiographically stable implant + no additional femoral reconstruction stable implant + no additional femoral reconstruction
次要结局
- Operative Time(Procedure)
- Subject Satisfaction(Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.)
- VAS Hip Pain(Baseline, Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.)
- Device Related Adverse Events(Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.)
- Length of hospital stay(2 Years)
- Estimated Blood Loss (EBL)(2 Years)
- HOOS Questionnaire(Baseline, Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.)
- Harris Hip Score(Baseline, Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.)