Direct Anterior Approach Versus Direct Lateral Approach in Cementless Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Muscle damage assay using Myoglobin biomarker
研究概览
简要总结
The purpose of this study is to compare the direct anterior approach and the direct lateral approach in primary total hip arthroplasty, regarding the postoperative function and pain, complications, radiological finds (X-ray), postoperative hemorrhage, markers for muscle damage (i.e creatine kinase (CK), lactate dehydrogenase(LDH/LD) , aspartate aminotransferase(AST), C-reactive protein (CRP),Troponin and Myoglobin) or other clinical outcomes.
详细描述
This is a prospective randomised controlled clinical trial and follow-up study comparing primary total hip arthroplasty performed either through a direct anterior approach or a lateral approach. At our hospital(i.e. Emergency County Hospital Cluj-Napoca), the lateral transgluteal approach was standard for more than 40 years. Starting 2008,the minimally invasive anterior approach was gradually implemented with the aim to facilitate early rehabilitation and improve functional results. Reduced blood loss, earlier functional recovery, low dislocation rates and shorter stays in hospital have been attributed to the muscle-sparing properties of the anterior approach.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiological diagnosis of coxarthrosis
- •Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.
排除标准
- •Previous surgery on affected hip
- •The patient has inflammatory arthritis.
- •The patient has any type of infection.
- •The subject has a known metal allergy.
- •Patients with co-existent ipsilateral knee disease or back problems
- •Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
- •Patients requiring bilateral hip replacement.
- •Patient with active major psychiatric illness
- •Patients whose body mass index (BMI; kg/m2) >
- •Patients with active or suspected infection or sepsis.
- •Patients with renal failure and/or renal insufficiency.
结局指标
主要结局
Muscle damage assay using Myoglobin biomarker
时间窗: Day of surgery
Before surgery, Myoglobin(ng/mL) baseline value is acquired in the morning, prior to any physical activity. Myoglobin value postoperatively is acquired at the 6 hour mark, when it reaches peak level. The change from baseline of the biomarker is calculated considering patient haemodilution.
Muscle damage assay using Troponin T biomarker
时间窗: Day of surgery
Before surgery, Troponin T(pg/mL) baseline value is acquired in the morning ,prior to any physical activity.Troponin T(TnT) value postoperatively is acquired at the 6 hour mark, when it reaches peak level. The change from baseline of the biomarker is calculated considering patient haemodilution.
次要结局
- Post Operative Pain Medication Usage(first 7 postoperative days - on a daily basis and then weekly for a 3 months period)
- Functional outcome using the 36-Item Short Form Health Survey (SF-36)(preoperative,and at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months)
- Muscle damage assay using Aspartate aminotransferase (AST)(Day of operation and next 7 consecutive days)
- radiological assessment of cup and stem osteointegration in the replaced hip(12 months postoperative)
- radiological assessment of stem positioning in the replaced hip(first day postoperative)
- Functional outcome using Harris Hip Score(preoperative,and at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months)
- Muscle damage - Creatine kinase (CK)(Day of operation and next 7 consecutive days)
- Functional outcome using the 20-meters-timed-walk(66 feet) test(at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months)
- Pain assessment using the Visual Numeric Scale(first 7 postoperative days - on a daily basis and then weekly for a 3 months period)
- Functional outcome using the Oxford Hip Score Survey(preoperative,and at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months)
- Functional outcome using the Stair Climbing Test (SCT)(at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months)
- radiological assessment of cup positioning in the replaced hip(first day postoperative)
- Muscle damage - Lactate dehydrogenase (LDH or LD)(Day of operation and next 7 consecutive days)
- Length of Hospital Stay(10 days postoperative)
研究者
Dan Viorel Nistor
Dan-Viorel Nistor MD
Iuliu Hatieganu University of Medicine and Pharmacy