Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- a) Incidence of TFL tendinopathy
研究概览
简要总结
During direct anterior approach (DAA) for total hip arthroplasty (THA), ligation of the lateral femoral circumflex artery and vessel is always conducted. However, this standardized procedure may jeopardize blood muscle perfusion and cause tenderness in the tensor fascia lata muscle. The investigators want to investigate whether blood vessel-sparing surgery is feasible, reproducible, and would alter outcomes following DAA THA.
The surgical technique of the vessel-sparing procedure will be described and investigated in a prospective blinded RCT. The investigators hypothesize that the vessel-sparing technique is feasible in 60% of the patients. If these vessels were not sacrificed, the investigators expect the incidence of TFL tendinopathy to be lower.
详细描述
Primary objective: to compare a group with successful vessel-sparing with a vessel-sacrificed-group for:
- Incidence of TFL tendinopathy
- Patient-reported outcomes
- Component placement Secondary objective: to observe the feasibility of the vessel-sparing surgical technique.
This is a monocentric prospective randomized blinded clinical trial during a period of minimum 3 years or until 150% of the sample size is included (100 patients).
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants will be blinded and randomized into two cohorts. The selection and randomization protocol is as follows: participants eligible for the study are requested to participate and informed by the study nurse. If the patient agreed to participate, informed consent is obtained, and the patient is included in the study. At that time, the study nurse uses a mobile randomization application (Random, Dublin, Ireland) to allocate them either to the 'standard' (sacrificing the vessels) or 'vessel sparing' DAA.
Weighted randomization (1:2) is applied to compensate for a dropout of patients planned for vessel sparing surgery, but in whom the vessels were damaged unintendedly. In case a bilateral procedure will be performed, each side is randomized individually.
Surgery will be performed by the surgeon. Data collection before and after surgery is collected by personal assistant who is unaware of group assignment.
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
- •To be eligible to participate in this study, a subject must meet all criteria below;
- •Scheduled for THA by Dr. Frans-Jozef Vandeputte or Professor Dr. Kristoff Corten
- •Provide signed and dated informed consent
- •Males or females age > 18 years
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Neurological problems with sensorial and/or motoric disturbances (Multiple Sclerosis, Parkinson's disease, hemiplegia, …)
- •Previous surgery of the ipsilateral hip
- •Ipsilateral neck of femur fracture
- •Previous contralateral THA
- •Significant hip deformity: Crowe type 3 and 4 dysplasia, Leg-Calvé-Perthes
- •Avascular necrosis of the femoral head
- •Participating in another study that may interfere with participation in this study
研究组 & 干预措施
Sacrificing vessels
干预措施: Vessel ligation technique (Procedure)
Sparing vessels
干预措施: Vessel sparing technique (Procedure)
结局指标
主要结局
a) Incidence of TFL tendinopathy
时间窗: one year follow-up
Clinical examination to detect TFL tendinopathy
b-4) Patient-reported outcome 4: Hip disability and Osteoarthritis Outcome Score (HOOS).
时间窗: one year follow-up
Hip disability and Osteoarthritis Outcome Score (HOOS) minimum (worse) score = 0 maximum (best) score = 100
b-2) Patient-reported outcome 2: Hip And Groin Outcome Score (HAGOS)
时间窗: one year follow-up
Hip And Groin Outcome Score (HAGOS) minimum (worse) score = 0 maximum (best) score = 100
b-1) Patient-reported outcome 1: modified Harris Hip Score (HHS)
时间窗: one year follow-up
modified Harris Hip Score (HHS) minimum (worse) score = 0 maximum (best) score = 44
b-3) Patient-reported outcome 3: Forgotten Joint Score
时间窗: one year follow-up
Forgotten Joint Score minimum (worse) score = 0 maximum (best) score = 100
c) Component placement (x-rays)
时间窗: one year follow-up
Using pelvic anteroposterior radiographs, with both legs internally rotated 15°: Acetabular version (Lewinnek method). Acetabular inclination Femoral alignment Under-sizing in case the femoral component is not touching cortical bone.
次要结局
- Vessel sparing succesfull(end of surgery)