NCT07150221Enrolling By Invitation不适用
Post-Market Clinical Follow-Up Study of the Vivacit-E Vitamin E Highly Crosslinked Polyethylene HXLPE Elevated Liners in Primary THA- A Retrospective Enrollment/Prospective Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Survival of the Implant System via Adverse Events
研究概览
简要总结
The main objective of this study is to confirm long-term safety, performance, and clinical benefits of the Vivacit-E Vitamin E HXLPE Elevated Liners when used in primary total hip arthroplasty.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient was 18 years of age or older and skeletally mature at the time of surgery
- •Patient qualified for and underwent surgical procedure with a Vivacit-E Vitamin E HXLPE Elevated Liner to treat one of the following indications in primary THA:
- •Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- •Protrusio acetabuli
- •Traumatic arthritis
- •Slipped capital epiphysis
- •Fused hip
- •Fracture of the pelvis
- •Diastrophic variant
- •Patient underwent surgical procedure 10 years (+ no maximum/- 182 days) prior to date of study consent
- •Patient is will and able to sign IRB approved Informed Consent Form or provide verbal consent
排除标准
- •Off label use or not according to the approved IFU at the time of surgery
- •Patient presented with any of the following at the time of the surgical procedure:
- •Osteoradionecrosis
- •Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation
- •Systemic or local infection
- •Revision procedure where other treatment or devices have failed*
- •Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
- •Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
- •For the purpose of this clinical study; a revision procedure refers to a procedure in which the prior procedure on the ipsilateral hip utilized a similar approach (i.e., primary total hip arthoplasty)
结局指标
主要结局
Survival of the Implant System via Adverse Events
时间窗: 10 years
The primary endpoint is defined by the survival of the implant system at 10 years post-operative, which is based on removal of the study device and will be determined using the Kaplan Meier method. The safety of the study device will be assessed by monitoring the frequency and incidence of adverse events.
次要结局
- Pain and functional performance measured by the Oxford Hip Score(10 years)
- Subject quality-of-life measured by the EQ-5D-5L(10 Years)
研究者
研究点 (1)
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