Prospective Randomised Controlled Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Materialise
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Acetabular cup positioning
研究概览
简要总结
A prospective, interventional, monocentric, controlled and randomized study will compare a conventional surgical technique to a surgical technique with the assistance of the Acetabular Cup Orientation Guide (ACOG, Materialise) System during total hip replacement (THR).
详细描述
Background: The Acetabular Cup Orientation Guide(ACOG) System from MATERIALISE NV was developed and is intended to be used as a surgical instrument to assist in the positioning of acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative computed tomography (CT) imaging scans.
Use of ACOG is a relative new technique. ACOG, based on CT imaging data, fit directly into the patient's anatomy and enable primary total hip replacement . Data showing extra benefit of this technique compared to conventional THR technique are not widely available.
Aim: To determine the safety of this new surgical technique compared to conventional THR.
Methods: 30 participants will be randomized to 2 groups. One group will be operated for a THR with the conventional technique and the other group will be operated for a THR with the assistance of the ACOG System. CT imaging will be taken pre and post operatively to measure cup orientation.
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
- Single (Outcomes Assessor)
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
- •Is selected to undergo a primary THR
- •Informed consent
排除标准
- •Is unable to undergo CT imaging of the full pelvis
- •Requires surgical treatment within less than 4 weeks of initiation
- •Is unable to undergo a THR through a anterolateral approach
- •Presents acute/chronic local or systemic infection
- •Is allergic to polyamide
- •Patient's BMI > 35
- •Patients with severe wear of the acetabular rim or other disorders that affect acetabular rim anatomy and bony landmark recognition.Patients exhibiting severe wear.
- •Has impaired decision-making capacity
- •Is a prisoner
- •Is pregnant
- •Has metal components that will result in scatter on the CT imaging
结局指标
主要结局
Acetabular cup positioning
时间窗: 2 Months post-operatively
Full leg computed tomography pre-operatively and post-operatively. Cup positioning will be recorded in both groups.
次要结局
- Surgery time(1 day)
- Acetabular cup size(2 months)