Intraoperative Manual Correction of Iliosacral Displacement of the Sacroiliac Joint in Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Hip function assessment
研究概览
简要总结
Degenerative changes in the hip joint, which are indications for operative treatment, are observed in more than 30% over the age of 50. In most cases, the development of a degenerative process in the hip joint is accompanied by changes in the sacroiliac joint. To improve the quality of life, relieve pain, improve the clinical outcomes of rehabilitation after total hip arthroplasty (THA), an integrated approach to treatment is required.
The investigators have developed a technique for intraoperative manual correction of the ileosacral displacement of the sacroiliac joint during THA. This clinical study compares the use of this technique during THA and THA by standard method.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent of the patient to participate in the study
- •Patients with osteoarthritis of the hip joint.
- •The opportunity for observation during the entire study period (12 months)
- •Mental adequacy, ability, willingness to cooperate and follow the doctor's recommendations
排除标准
- •The refusal of a patient from surgery
- •The presence of contraindications to surgery
- •Severe forms of diabetes (glycosylated hemoglobin >9%)
- •Previously performed surgeries on the lumbar spine
- •Blood diseases (thrombopenia, thrombocytopenia, anemia with Hb< 90g\l)
- •The unwillingness of the patient to conscious cooperation.
结局指标
主要结局
Hip function assessment
时间窗: 12 months after surgery
The Harris Hip Score (HSS). The HHS is a measure of disfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Pain assessment
时间窗: 12 months after surgery
Visual Analogue Scale (VAS) - assessment or the severity of pain syndrome. The score is determined by measuring the distance (mm) on a 10 cm line between the no pain anchor point and the patient's mark, giving a value range from 0 to 100 (0 - min; 100- max)
次要结局
未报告次要终点