Assessment of Functional Outcomes of Custom-made Articulating Spacers in Two Stage Arthroplasty for Treatment of Infected Hip Joint
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Functional outcomes of CUMARS during interstage period
研究概览
简要总结
The goal of this prospective observational study is to evaluate whether the use of a Custom-Made Articulating Spacer (CUMARS) can achieve satisfactory functional outcomes and effective infection control in patients undergoing two-stage revision for infected hip joints.
The main questions it aims to answer are:
Does the use of CUMARS provide acceptable functional outcomes during the interim period and after definitive reimplantation?
Does CUMARS result in effective infection eradication with acceptable perioperative parameters and complication rates?
Participants will:
Undergo first-stage removal of the infected hip prosthesis and implantation of a Custom-Made Articulating Spacer
Receive targeted systemic antibiotic therapy based on culture results
Be followed up clinically and radiologically to assess function, complications, and infection status
Undergo second-stage definitive hip reimplantation after confirmation of infection eradication
详细描述
Purpose: This prospective study aimed to evaluate the functional outcomes, perioperative parameters, complication rates, and infection eradication achieved with the use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints.
Methods: This prospective single-arm study was conducted at a tertiary referral center and included 25 patients with chronic hip joint infections . All patients underwent two-stage revision with implantation of a CUMARS construct at the first stage. Functional outcomes were assessed using the Modified Harris Hip Score (mHHS) and Visual Analogue Scale (VAS) for pain. Perioperative parameters, complication rates, and infection eradication were also evaluated during the 2 stage procedure . Minimum follow-up after reimplantation was 24 months.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 20-80 years old
- •Patients with PJI after hip arthroplasty according to MSIS criteria 2018 OR ICM
- •PJI > 4 weeks post operative
- •Patients with chronic septic hip arthritis (either native or on top of infected proximal femur implant)
排除标准
- •Age less than 20 years
- •Early postoperative PJI
- •Acute Hematogenous PJI
- •Fungal infection
- •Acute septic hip
- •gouty arthritis
研究组 & 干预措施
Participants with chronic periprothetic hip joint infection
Participants will:
Undergo first-stage removal of the infected hip prosthesis and implantation of a Custom-Made Articulating Spacer
Receive targeted systemic antibiotic therapy based on culture results
Be followed up clinically and radiologically to assess function, complications, and infection status
Undergo second-stage definitive hip reimplantation after confirmation of infection eradication
干预措施: the use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints. (Procedure)
结局指标
主要结局
Functional outcomes of CUMARS during interstage period
时间窗: both measured preoperative and 1 month -postoperative first stage for each patient
Functional outcomes were assessed using the Modified Harris Hip Score (mHHS) ( ranges from a minimum of 0 points (worst possible function/highest pain) to a maximum of 100 points (best possible function/no pain).
次要结局
- Impact on second stage(Perioperative parameters surgery time meaured during 1st stage and 2nd stage procedures)
- Impact on second stage(blood loss during 1st stage and 2nd stage procedures)
- Efficiency in controlling infection.(infection eradication rate 12 month post 2nd stage)
- Complication rate during interstage period(Complication rates during interstage period)