NL-OMON56781已完成不适用
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Vanguard PS Open Box Porous Femoral (Implants and Instrumentation) - A Consecutive Series Study - PILLAR
Amsterdam UMC0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
- 18 至 99（—）
入选标准
- •This study is focused on patients treated with the Vanguard PS Open Box Porous
- •Femoral between 2009 and 2013 within the Amsterdam UMC, location AMC.
- •The Vanguard PS Open Box Porous Femoral prosthesis is indicated for patients
- •treated for:
- •Painful and disabled knee joint resulting from osteoarthritis, rheumatoid
- •arthritis, traumatic arthritis where one or more compartments are involved.
- •Correction of varus, valgus, or posttraumatic deformity.
- •Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of
- •previous joint replacement procedure.
- •Additionally, in order to be eligible to participate in this study, a subject
- •must meet the following criteria:
- •The participant must be able to understand the Dutch language in order to
- •complete the questionnaires.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •Off label use.
- •Absolute contraindications include:
- •Infection.
- •Osteomyelitis.
- •Relative contraindications include:
- •An uncooperative patient or a patient with neurologic disorders who is
- •incapable of following directions.
- •Osteoporosis.
- •Metabolic disorders which may impair bone formation.
- •Osteomalacia.
- •Distant foci of infections which may spread to the implant site.
- •Rapid joint destruction, marked bone loss or bone resorption apparent on
- •roentgenogram.
- •Vascular insufficiency, muscular atrophy, neuromuscular disease, and/or
- •incomplete or deficient soft tissue surrounding the knee.
- •Subgroup exclusion criteria:
- •For the subgroup analysis to determine variability in methodological error,
- •bilateral patients are excluded from the subgroup since they will already be
- •exposed to an additional scan.
研究者
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