NCT01028469Unknown4 期
Artelon MTP Spacer - Surgical Treatment of Mild to Moderate Hallux Rigidus
Artimplant AB1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年12月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pain, function and alignment of the treated toe evaluated by the investigator using the American Orthopeadic Foot & Ankle Society (AOFAS) clinical rating system.
研究概览
简要总结
The aim of this prospective, case series is to evaluate the surgical treatment of painful and disabling osteoarthrosis in the MTP-I joint by insertion of an Artelon MTP Spacer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient experiences pain and limitations of the great toe dorsiflexion at the MTP-I joint.
- •The patient has a clinically and radiographically verified arthritis in the MTP-I joint indicating the need for surgical treatment.
- •The patient reads, understands and is able to complete the study questionnaires in Swedish.
- •The patient has received written and oral information regarding the study and has signed the informed consent form.
排除标准
- •The patient has a pronounced hallux rigidus without mobility in the MTP-I joint (ROM = 0°).
- •The patient has previously received surgical treatment affecting the anatomy of the MTP-I joint.
- •The patient has a systemic rheumatic disease, ongoing infection, hallux valgus or is seriously ill.
结局指标
主要结局
Pain, function and alignment of the treated toe evaluated by the investigator using the American Orthopeadic Foot & Ankle Society (AOFAS) clinical rating system.
时间窗: pre-treatment and 12 months post-op
次要结局
未报告次要终点
研究者
研究点 (1)
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