"Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 6
- 主要终点
- Ankle range of motion
研究概览
简要总结
The study analyzes the effectiveness of different ultrasound-guided surgical techniques to treat gastrocnemius contracture and equinus deformity, conditions that affect ankle dorsiflexion and can cause problems such as plantar fasciitis and metatarsalgia. Four techniques were compared: Strayer, Plantaris, Baumann and Gastro-soleo, evaluating their impact on the improvement of ankle motion.
详细描述
Equinus deformity is a common deformity caused by contracture of the triceps suralis, especially the gastrocnemius. This causes limitation of ankle dorsiflexion, pain and gait incompetence. Treatment includes surgical lengthening techniques such as gastrocnemius tendon recession (Strayer) or isolated plantar tendon transection.
The minimally invasive Strayer technique is effective but carries morbidity. Ultrasound-guided plantar tendon transection is a new minimally invasive technique but its effectiveness has not been well established.
The study will evaluate the effectiveness of four ultrasound-guided surgical techniques in improving ankle dorsiflexion in patients with equinus due to gastrocnemius contracture. The Strayer, Plantaris, Baumann, and Gastro-soleo techniques will be compared, analyzing their impact on mobility before and after surgery.
Patients will be assigned to different groups based on the applied technique, following specific inclusion and exclusion criteria for each procedure. For statistical analysis, Wilcoxon and paired Student's t-tests will be used, depending on data distribution. Additionally, a repeated-measures ANOVA with Tukey's post-hoc tests will be applied to compare the results between techniques and determine which achieves the greatest increase in dorsiflexion range.
All techniques are expected to significantly improve dorsiflexion, with differences in the magnitude of change. The Gastro-soleo technique is anticipated to show the highest absolute increase, while Strayer may be the most statistically effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
To reduce bias, the study will use double-blind blinding. Patients will not know the group to which they have been assigned. In addition, the assessors performing the ankle range of motion measurements by goniometry will be blinded to each patient's treatment group.
Randomization to each group will be performed using opaque sealed envelopes that will be opened in the operating room just prior to surgery. Neither the surgeon nor the patient will know the assignment until that time.
The statistical analysis will also be performed in a blinded manner, without the statistician knowing the intervention received by each group. Only after the analysis will the groups be unblinded.
In this way, the aim is to reduce the possibility of knowledge of the assigned treatment influencing the evaluation of the results, both on the part of the patients and of the evaluators and analysts.
入排标准
- 年龄范围
- 10 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiological diagnosis of clubfoot.
- •Limitation of passive dorsiflexion of the ankle (<10°).
- •Associated pain and functional limitation
- •Absence of previous ankle/foot surgeries
排除标准
- •Neurologic or congenital disease.
- •Advanced ankle joint osteoarthritis
- •Peripheral vascular insufficiency
- •Uncontrolled diabetes mellitus
- •Severe hepatic or renal disease
- •Coagulopathies or anticoagulant therapy
结局指标
主要结局
Ankle range of motion
时间窗: Pre-surgery, 2 months, 6months and 1 year.
Measurement in degrees of the passive dorsiflexion range of the ankle using a goniometer, with the patient in supine position and knee extended.
次要结局
- American Orthopedic Foot and Ankle Score(Pre-surgery,2 months,6months and 1 year.)
- Visual Analog Scale.(Pre-surgery,2 months,6months and 1 year.)
- Complications(Pre-surgery,2 months,6months and 1 year.)