NCT07567092招募中不适用
VIRTUGUIDE™ SYSTEM REGISTRY
DePuy Synthes Products, Inc.8 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年7月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 8
研究概览
简要总结
The purpose of this study is to assess the surgeon experience and surgery outcomes in participants undergoing index Lapidus procedure for the correction of hallux valgus (a foot deformity where the big toe angles outward towards the other toes, causing a painful bony bump at the base of the big toe joint) using the VIRTUGUIDE System and compatible DePuy Synthes Lapidus implants.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants, both male and female, >= 22 years old at the time of consent
- •Participants undergoing a primary Lapidus procedure for the correction of hallux valgus using the VIRTUGUIDE System (software + instruments) and who receive a compatible DePuy Synthes Lapidus implant
- •Participants must be able to read and understand questions and responses in an available translated language for patient reported outcomes (PROMs)
- •All primary Lapidus fixation implants are used on-label according to the implant IFU/FDA cleared labeling
- •Participants who can speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and are willing and able to provide informed patient consent for participation and have authorized the transfer of his/her information to DePuy Synthes
排除标准
- •Participation in any other medical device or medicinal product study within the previous month. Participation in observational studies is allowed
- •In the opinion of the Principal Investigator, the subject is unable to comply with the requirements of the registry
- •Participant has known allergies to implant components
- •Participant presenting for a revision of a Lapidus procedure
- •Participant has existing hardware in the operative joint
研究组 & 干预措施
VIRTUGUIDE System and Compatible DePuy Synthes Lapidus Implant(s)
Participants with hallux valgus undergoing index Lapidus procedure using the VIRTUGUIDE System and compatible DePuy Synthes Lapidus implant(s) will be enrolled in the study. All participants will be followed up as per the surgeon's standard of care for up to 12 months after the surgery.
研究者
研究点 (8)
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