NCT07538141招募中不适用
The Hyalex First-in-Human Study - A Prospective, Single-Arm, Feasibility Study of the HYALEX SLALOM MTP Hemiarthroplasty Implant
Hyalex Orthopaedics, Inc.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Freedom from implant rejection, infection
研究概览
简要总结
The HYALEX SLALOM MTP Hemiarthroplasty System consists of a synthetic implant designed to replace the distal metatarsal surface of the great toe for treatment of arthritis . The system is composed of the HYALEX MTP Implant and instrumentation. The implant consists of the HYALEX Cartilage material bonded to a titanium backing.
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
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21-75 years;
- •Body Mass Index (BMI) ≤ 38;
- •Degenerative or post-traumatic arthritis of the first metatarsal joint with ICRS grade 2, 3, or 4;
- •Pre-operative VAS pain score of >40;
- •Presence of good bone stock, without need for bone graft
排除标准
- •Known allergy to polyurethanes, bone cement, acrylic, or titanium;
- •Due to anatomy and/or lesion location, inability to position the implant flush or slightly proud relative to the articular surface precluding proper device placement;
- •Lack of 2mm of vital bone on all sides of implant site;
- •Cartilage lesions on the phalanx of ICRS Grade 3 - 4 opposite the lesion intended for treatment;
- •Additional ipsilateral lower limb (hip, knee, ankle, or foot) pathology that requires active treatment (e.g., surgery, brace);
- •Bilateral degenerative or post-traumatic arthritis of the MTP joints that would require simultaneous treatment of both MTP joints;
- •Previous cheilectomy resulting in inadequate bone stock;
- •Diagnosis of gout;
- •Hallux varus to any degree or hallux valgus >20;
- •Hyper mobility at proximal metatarsal joint;
- •Interphalangeal angle >15
研究组 & 干预措施
Implantation of HYALEX SLALOM MTP Hemiarthroplasty Implant
Experimental
干预措施: MTP Hemiarthroplasty (Device)
结局指标
主要结局
Freedom from implant rejection, infection
时间窗: Through 12 months
Assess the safety and performance of the HYALEX SLALOM MTP Hemiarthroplasty Implant
Improvement in VAS pain
时间窗: 12 months
VAS pain improvement over time
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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