Legs Dysmetria in Total Hip Replacement: Does Hip Approacches and Navigation Decrease the Risk?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Legs dysmetria in millimeters calculated in anteroposterior x-rays
研究概览
简要总结
The purpose of this study is to collect clinical and radiological data from the case series of patients surgically treated with total hip arthroplasty at the Rizzoli Orthopaedic Institute.
The primary objective is to evaluate in terms of safety and efficacy the reduction of legs dysmetria and proper acetabular cup inclination intraoperatively when comparing anterior, direct lateral, and postero-lateral hip approaches conducted via traditional or navigation-assisted surgery.
The secondary objectives of the study are to evaluate, by comparing navigation-assisted and non-navigation-assisted hip approaches, intraoperatively the correct positioning of the prosthesis by analyzing the acetabular cup version; surgical timing; and number of intraoperative radiographs taken. In addition, the accuracy of preoperative planning will be assessed and a clinical evaluation performed during a follow-up of one year.
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 (Participant)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50 and 80 years;
- •Signs and symptoms of hip osteoarthritis (pain intensity of at least 6 points of visual analogic scale pain - 0-10 scale in the previous week);
- •Radiographic signs of hip osteoarthritis (Grade 3-4 according to Tonnis classification);
排除标准
- •Patients unable to express consent;
- •Patients undergoing previous ipsilateral hip surgery;
- •Patients undergoing lower limb surgery to be treated in the previous 12 months;
- •Patients with malignant neoplasms;
- •Patients with rheumatic diseases;
- •Patients with uncontrolled diabetes;
- •Patients with uncontrolled thyroid metabolic disorders;
- •Patients abusing alcoholic beverages, drugs or medications;
- •Body Mass Index > 35;
- •Pregnant and/or fertile women.
- •Pain intensity less than 6 points in accordance with the visual analogic scale scale.
- •Patients with the presence of excessive deformity resulting from acetabular or femoral head dysplasia
- •Patients who have already undergone total hip arthroplasty surgery on the affected hip.
- •Previous extensive surgery of the reference joint (osteotomy around the hip, open or arthroscopic osteochondroplasty for femoral-acetabular conflict).
结局指标
主要结局
Legs dysmetria in millimeters calculated in anteroposterior x-rays
时间窗: Intraoperatory
Legs lenght dysmetria in total hip replacement surgery
次要结局
- Cup orientation in grade° calculated in anteroposterior x-rays(Intraoperatory)