A Randomized, Prospective, Single-blind Controlled Clinical Trial to Systematically Assess the Need for Transosseous Anchoring in the Anterolateral Approach to Primary Hip Prosthetic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Trendelenburg Test
研究概览
简要总结
The study aims to discuss the challenges associated with breakage or failure of the abductor mechanism after total hip arthroplasty, which can lead to gait issues, instability, and the need for revision surgery. Sutures play a crucial role in preventing these failures, with two main types: transosseous and tendon sutures. Transosseous suturing involves using non-absorbable threads anchored in the bone, while tendon suturing uses absorbable threads for layered closure.
Both techniques are commonly used, but there is a lack of evidence to determine which is more beneficial for patients. Current studies are limited and often focus on cases requiring revision surgery due to complications, with transosseous sutures generally being the preferred method.
A meta-analysis indicated that transosseous repair may result in lower dislocation rates and less postoperative pain, but further randomized clinical trials with long-term follow-up are necessary for definitive conclusions. The text proposes a prospective study to compare transosseous suturing with the common absorbable tendon suturing in primary hip surgeries.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult population
- •Patients diagnosed with coxarthrosis (stages 2 and 3), confirmed by X-ray, according to D. Tonnis's classification of 1972
- •Willingness to follow up for up to 12 months
- •Patients capable of understanding the study and giving their informed consent
排除标准
- •Difficulty understanding and following the study procedure
- •Patients with previous surgery on the same hip
- •Patients with a diagnosis other than the inclusion criteria (e.g. acute femoral fracture requiring total hip arthroplasty
结局指标
主要结局
Trendelenburg Test
时间窗: preoperative and 3 months
It evaluates the paradoxical elevation of the pelvis in monopodal support on the observed limb. It suggests insufficiency or rupture of the abductor apparatus. It can be positive (+), that is, suggesting abductor pathology, or negative (-), that is, suggesting the absence of a clinical problem in that segment. This is a clinical test that is usually performed during preoperative and follow-up visits to the patient and does not present any risks for the patient. It is performed with the patient standing with body weight evenly distributed. The examiner stands behind the patient and identifies the iliac crests and posterior superior iliac spine. The patient raises the leg that is contralateral to the side being evaluated.
次要结局
- Pain Level(Preoperative at 24 and 48 hours and postoperative at 3, 6 and 12 months)
- Quality of life(Preoperative, 3, 6 and 12 months.)
- Surgeons sensation(3 and 12 months)
- Patient Satisfaction(3 and 12 months)
- Complications(Up to 1 year)
- Complementary tests(Up to 1 year)
研究者
Mireia Vinas Noguera
Doctor
Corporacion Parc Tauli