Proximal Versus Distal Tenotomy of the Iliopsoas Tendon in the Surgical Treatment of Developmental Dysplasia of the Hip: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- hip flexion strength
研究概览
简要总结
The goal of this clinical trial is to compare the postoperative clinical outcome of iliopsoas tenotomy in open reduction operation for developmental dysplasia of the hip. The main aim is to compare the postoperative clinical outcome of division of iliopsoas tendon at two levels, proximally at the pelvic brim and distally just above the lesser trochanter.
详细描述
All the patients with DDH included in the current study underwent open reduction of their dislocated hip through the anterior approach. None of the included patients underwent hip surgery through the medial approach.
For the proximal level of psoas tenotomy at the pelvic brim, the hip was slightly flexed to relax the iliopsoas muscle; the iliacus muscle fibers were retracted anteriorly until the deeply seated posteromedially psoas tendon was isolated and transected. For the distal level of iliopsoas tenotomy just above the lesser trochanter, the thigh was put in the position of FABER (flexion, abduction, and external rotation). A curved right-angle hemostatic clamp was used to retract and bring the iliopsoas tendon into the field. Then, the tendinous fibers were transected.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The patients, their parents/guardians, and the person who assessed the primary outcome were blinded to the type of intervention and the randomization sequence. The primary outcome assessor was a physiotherapist already trained in rehabilitating children with orthopedic disorders and the manual muscle strength testing scale. The assessment of the primary outcome was done in the physiotherapy department of the EDCD center.
入排标准
- 年龄范围
- 1 Year 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with DDH.
- •Required open reduction of their hip problem.
排除标准
- •Patients who underwent hip surgery without the need for sectioning the iliopsoas tendon.
- •Children with mental retardation who were not cooperative in the assessment of the hip flexion strength.
研究组 & 干预措施
Group 1
For the proximal level of psoas tenotomy at the pelvic brim, the hip was slightly flexed to relax the iliopsoas muscle; the iliacus muscle fibers were retracted anteriorly until the deeply seated posteromedially psoas tendon was isolated and transected
干预措施: Proximal level (Procedure)
Group 2
. For the distal level of iliopsoas tenotomy just above the lesser trochanter, the thigh was put in the position of FABER (flexion, abduction, and external rotation). A curved right-angle hemostatic clamp was used to retract and bring the iliopsoas tendon into the field. Then, the tendinous fibers were transected.
干预措施: Distal level (Procedure)
结局指标
主要结局
hip flexion strength
时间窗: at 6th, 12th, and 24th months post-operatively
The strength was assessed clinically using the Medical Research Council Manual Muscle Testing scale. It evaluated muscle strength by testing the key muscle against gravity and the examiner's resistance. The scale graded muscle strength into six grades (from 0 to 5): Grade 0, no muscle activation and no movement; Grade 1, trace muscle activation, a flicker of movement, but without achieving full range of motion; Grade 2, muscle activation and achieving full range of motion with eliminated gravity; Grade 3, muscle activation and achieving full range of motion against gravity; Grade 4, muscle activation and achieving full range of motion against some resistance; Grade 5, muscle activation and achieving full range of motion against strong resistance.
次要结局
- complications(12 months)
研究者
Jagar Omar Doski
Assistant Professor
University of Duhok