Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Non-Invasive Navigation
概览
- 阶段
- 不适用
- 干预措施
- EMPHASYS Cup with VHN
- 疾病 / 适应症
- Osteoarthritis
- 发起方
- DePuy Orthopaedics
- 入组人数
- 118
- 试验地点
- 6
- 主要终点
- Composite endpoint: Acetabular Cup Position Success at 6 Weeks
- 状态
- 招募中
- 最后更新
- 19天前
概览
简要总结
The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup') placement in total hip replacement surgery using a non-invasive surgical navigation system called VELYS™ hip navigation system with CUPTIMIZE™ Advanced Hip-Spine Analysis software.
Data collected in this study will be compared with data collected from implantations using different cup positioning instrumentation and techniques to assess performance.
研究者
入排标准
入选标准
- •All hip replacement component devices are to be used according to the approved indications.
- •The subject is undergoing a standard of care primary uncemented hip replacement with the EMPHASYS cup and a CORAIL, EMPHASYS or ACTIS stem via the posterolateral, anterolateral, or direct lateral approach with the subject in the lateral decubitus position.
- •The subject is a candidate for implantation utilizing the VELYS Hip Navigation system with CUPTIMIZE advanced
- •Individuals who are able to speak, read, and comprehend the Informed Participant Consent Document and willing and able to provide consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes.
- •Individuals who are willing and able to complete follow-up as specified by the study protocol.
- •Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires (i.e., FJS-12, EQ-5D-5L and Hip Evaluation) as specified by the study protocol.
- •Individuals who are not bedridden per the discretion of the investigator.
- •Individuals who are a minimum age of 21 years at the time of consent
排除标准
- •Active local or systemic infection.
- •Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
- •Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
- •Charcot's or Paget's disease.
- •The Subject is a woman who is pregnant or lactating.
- •Subject had a contralateral amputation.
- •Previous partial hip replacement in affected hip.
- •Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
- •Contralateral hip was replaced less than 6 months prior to surgery date.
- •Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
研究组 & 干预措施
EMPHASYS Cup with VHN
EMPHASYS Cup with Non-Invasive Navigation
干预措施: EMPHASYS Cup with VHN
结局指标
主要结局
Composite endpoint: Acetabular Cup Position Success at 6 Weeks
时间窗: 6 Weeks
For an individual cup position to be considered successful, the cup's placement must satisfy all of the following criteria at 6 weeks: Inclination Success: within 10 degrees of the planned inclination via the surgeon-defined preoperative plan and version Success: within 10 degrees of the planned version via the surgeon-defined preoperative plan.
次要结局
- Harris Hip Score(12 weeks)
- Radiographic Outcomes(12 weeks)
- EQ-5D-5L(12 weeks)
- Forgotten Joint Score(6 weeks)
- Operating Room Times(Immediately after the Surgical Procedure)
- Leg Length Discrepancy(Immediately after the Surgical Procedure)
- Complication Rates(90 days)
- Harris Hip Score(12 weeks)
- EQ-5D-5L(12 weeks)
- Operating Room Times(Immediately after the Surgical Procedure)
- Final Intraoperative Version(12 weeks)
- Forgotten Joint Score(6 weeks)
- Final Intraoperative Inclination(12 weeks)
- Radiographic Outcomes(12 weeks)
- Inclination Success(6 weeks)
- Version Success(6 weeks)
- Leg Length Discrepancy(Immediately after the Surgical Procedure)
- Complication Rates(90 days)
- Complication Rates(30 days)