NCT01285011已完成不适用
Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal
Integra LifeSciences Services5 个研究点 分布在 3 个国家目标入组 156 人开始时间: 2009年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 5
- 主要终点
- Rate of device related complications
研究概览
简要总结
Hammertoe and ClawToe are ones of the most common foot deformities. The second toe is the most frequently affected, but the other small toes may also be involved. When nonoperative treatment fails, surgery often is recommended. One surgical option is the arthrodesis of the Proximal Interphalangeal (PIP) joint. This arthrodesis is technically demanding, its needs:
- Internal fixation;
- Interphalangeal Compression;
- Anatomic PIP joint plantar flexion angle. The implant Ipp-On has been developed for this specific arthrodesis. The objective of this study is to evaluate the efficacy and safety of the Proximal Interphalangeal Implant: Ipp-On at short term follow up.
The safety of the Ipp-On will be described in terms of rate of device related complications.
The efficacy of the Ipp-On will be described in terms of fusion rate at 6 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient who needs a proximal interphalangeal joint arthrodesis for whose surgeon has recommended that a proximal Interphalangeal Implant Ipp-On be implanted
- •Age >= 18 years
- •Have willingness to give his/her Data Transfer Authorization
排除标准
- •Contraindication of the implantation of the Ipp-On The implant should not be used in a patient who has currently, or who has a history of: • Active local or systemic infection
- •Severe peripheral vascular disease
- •Severe longitudinal deformity
- •Insufficient quantity or quality of bone to permit stabilization of the arthrodesis
- •Conditions that restrict the patient's ability or willingness to follow postoperative instructions during the healing process
- •Suspected or documented metal allergy or intolerance.
- •History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
结局指标
主要结局
Rate of device related complications
时间窗: 12 months
fusion rate
时间窗: 6 months
次要结局
- Subjective assessment(6 months/12 months)
- Clinical Assessment(6 months/12 months)
- Fusion rate(3 months)
- American Orthopaedic Foot and Ankle Society Lesser Metatarsophalangeal Scale (AOFAS LMIS) score(6 months/12 months)
- Radiological Evaluation(6 months/12 months)
研究者
研究点 (5)
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