NCT07079774招募中不适用
Post-Market Clinical Follow-up Study of the TrueLok Elevate Transverse Bone Transport System for the Treatment of Lower Limb Ulcers as Soft Tissue Defects
Orthofix s.r.l.14 个研究点 分布在 6 个国家目标入组 153 人开始时间: 2025年11月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 153
- 试验地点
- 14
- 主要终点
- Complete ulcer healing
研究概览
简要总结
The TrueLok Elevate Transverse Bone Transport System is a modular external fixation device designed for transverse bone transport. It promotes local vascular and wound healing through controlled corticotomy and gradual distraction. The system is intended for adult patients with bony and/or soft tissuedefects.
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
- •Aged 18 years or older at the time of surgery Willing and able to sign and date the study-specific informed consent form in accordance with national and institutional ethics requirements Willing and able to comply with requirements of the protocol, including follow-up requirements Indicated for surgical intervention using the TrueLok Elevate Transverse Bone Transport System for the treatment of soft tissue defects in the form of lower limb ulcers
- •Presence of a chronic ulcer, defined as:
- •Present for at least 3 months, and
- •Unresponsive to standard non-surgical or surgical wound management, including but not limited to debridement, negative pressure wound therapy (VAC), offloading, antibiotics, or vascular optimisation
排除标准
- •Mental or cognitive impairment or physiological or behavioural conditions that, in the opinion of the investigator, would preclude reliable adherence to postoperative care instructions, follow-up assessments, or study procedures
- •Known or presenting with the following signs of a systemic inflammatory response syndrome (SIRS) as exhibiting two or more of the following conditions:
- •Heart rate >90 beats/min
- •Respiratory rate >20 breaths/min
- •PaCO2 <32-mm Hg
- •White blood cell count >12.000 or <4.000/cu mm
- •10% immature (band) forms Known hypersensitivity or allergy to any material used in the TrueLok Elevate Transverse Bone Transport System (e.g., stainless steel, titanium) Current participation in another interventional clinical study that, in the opinion of the investigator, may interfere with the objectives or outcomes of this study Presence of active malignancy or systemic infection that, in the investigator's opinion, may interfere with wound healing or the study protocol Life expectancy of less than 12 months Simultaneous bilateral application of the TrueLok Elevate Transverse Bone Transport System Current incarceration at the time of enrolment Any condition or clinical circumstance that, in the opinion of the investigator, would make participation not in the best interest of the subject or would interfere with the study objectives
结局指标
主要结局
Complete ulcer healing
时间窗: 12 months
Proportion of subjects achieving complete ulcer healing within 12 months of device removal. Healing is defined as full epithelialisation with no open wound.
次要结局
未报告次要终点
研究者
研究点 (14)
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