Randomised Controlled Trial Comparing Partial Calcanectomy Plus Local Application Antibiotic Impregnated Bone Graft Substitute for Calcaneal Osteomyelitis vs Partial Calcanectomy Alone (The ACHILLS Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Rate of Wound Healing
研究概览
简要总结
The ACHILLS Trial is a multicentre randomised controlled feasibility study comparing partial calcanectomy with and without the use of an antibiotic-impregnated bone graft substitute (Cerament G) for treating calcaneal osteomyelitis, specifically on wound healing rates, re-infection, and overall efficacy in a sample of 30 patients over a one-year period.
详细描述
Calcaneal osteomyelitis is a severe infection of the heel bone, frequently linked to peripheral arterial disease and diabetes, which complicates the healing process. This condition can lead to chronic wounds, persistent pain, and, in extreme cases, the need for limb amputation. Standard treatment often involves partial or total calcanectomy, where the infected bone is surgically removed, significantly impacting patients' mobility and quality of life.
The ACHILLS Trial is a multicentre, randomised controlled feasibility study designed to assess the efficacy of partial calcanectomy with and without the use of Cerament G, an antibiotic-impregnated bone graft substitute.
The primary objective is to determine the rate of wound healing in patients undergoing partial calcanectomy for osteomyelitis who receive Cerament G.
Secondary objectives include assessing time to wound healing, rates of re-infection, hospital stay duration, need for extended antibiotic therapy, financial impact, and overall quality of life.
The trial will involve 30 participants, aged 18 and older, undergoing partial calcanectomy for osteomyelitis. Participants will be randomly assigned to one of two groups: one receiving partial calcanectomy with Cerament G, and the other receiving partial calcanectomy alone with standard antibiotic therapy. The study will monitor patients for one year, with data collected at multiple intervals to monitor wound healing, re-infection rates, and other outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •18 and over
- •Undergoing partial calcanectomy
- •Patients with Type1 or Type 2 Diabetes
- •Patients will be stratified by Pulse status and eGFR
排除标准
- •Patients unfit for surgery
- •Patients unable to provide informed consent
- •Patients with overwhelming sepsis that require major amputation
- •Patients with hypersensitivity to aminoglycosides
- •Pre-existing calcium metabolism disorder
- •Severe renal impairment
- •Patients in whom major limb amputation is deemed inevitable by the treating physician
研究组 & 干预措施
Partial Calcanectomy with Cerament G
Patients will undergo partial calcanectomy with the application of Cerament G.
干预措施: Cerament G (Device)
Standard Partial Calcanectomy
Patients will undergo partial calcanectomy with standard antibiotic therapy.
干预措施: Standard Surgical Managment (Other)
结局指标
主要结局
Rate of Wound Healing
时间窗: 12 months post-surgery
To determine the number of patients achieving complete wound healing in patients undergoing treatment with cerament G compared to those with partial calcanectomy alone by measuring wound volume
次要结局
- Time to Wound Healing(1, 3, 6, and 12 months post-surgery)
- Quality of life measured with the EQ5D5L (Health Questionnaire)(12 months post-surgery)
- Cost to Patients Questionaire (CoPaQ)(12 months post-surgery)
- Length of Hospital Stay(12 months post-surgery)
- Time to Wound Healing(1, 3, 6, and 12 months post-surgery)
- Quality of life measured with the EQ5D5L (Health Questionnaire)(12 months post-surgery)
- Cost to Patients Questionaire (CoPaQ)(12 months post-surgery)
- Length of Hospital Stay(12 months post-surgery)